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D000437: Alcoholism

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (24)


Name (Synonyms) Correlation
drug490 BCG-Denmark Wiki 0.41
drug4801 [14C]-radiolabelled BI 1358894 Wiki 0.35
drug3204 Placebo (for Zonisamide) Wiki 0.35
Name (Synonyms) Correlation
drug496 BI 1358894 Wiki 0.35
drug488 BCG vaccine (Freeze-dried) Wiki 0.35
drug3194 Pitolisant Wiki 0.35
drug1614 FITSTART+ PBI Wiki 0.35
drug738 CBD Isolate Wiki 0.35
drug1719 Full Spectrum CBD Oil Wiki 0.35
drug2270 Ketamine Hydrochloride Wiki 0.35
drug492 BGB DXP593 Wiki 0.35
drug1776 General Parenting Advice Wiki 0.35
drug4284 Take Control Wiki 0.35
drug4754 Woebot Substance Use Disorder Wiki 0.35
drug2746 Naltrexone 380 MG Wiki 0.35
drug1509 Enhanced linkage Wiki 0.35
drug1847 HaRTC Wiki 0.35
drug3230 Placebo Oil Wiki 0.35
drug493 BGB-DXP593 Wiki 0.35
drug4796 Zonisamide Wiki 0.35
drug3844 Saline Wiki 0.21
drug486 BCG Vaccine Wiki 0.18
drug487 BCG vaccine Wiki 0.18
drug3195 Placebo Wiki 0.06

Correlated MeSH Terms (7)


Name (Synonyms) Correlation
D000428 Alcohol Drinking NIH 0.50
D019966 Substance-Related Disorders NIH 0.27
D015775 Fractures, Stress NIH 0.25
Name (Synonyms) Correlation
D000435 Alcoholic Intoxication NIH 0.25
D020920 Dyssomnias NIH 0.13
D020447 Parasomnias NIH 0.12
D004194 Disease NIH 0.06

Correlated HPO Terms (0)


Name (Synonyms) Correlation

Clinical Trials

Navigate: Correlations   HPO

There are 8 clinical trials


1 Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism

Alcoholism is the third leading cause of preventable death in the US, accounting for 80,000 deaths annually. Almost 18 million US adults have alcohol use disorder (AUD); however, approved medications for the treatment of AUD has shown limited effectiveness. Zonisamide (ZON), a broad spectrum anticonvulsant, has proven to be more effective than a placebo in reducing alcohol intake in individuals with alcohol dependence. ZON's mechanism of action seems to be quite distinct from currently approved anti-alcoholism medications, which holds promise for treatment of individuals who are not responsive to conventional medications. However, much remains unknown about ZON's therapeutic mechanisms and ZON's efficacy in treating patients with a diagnosis of AUD. To fill in these gaps, the investigators will conduct a double-blind randomized controlled study that assesses ZON's treatment mechanisms and effectiveness in reducing alcohol consumption in patients with AUD. Participants will be randomized to one of two conditions: 1) treatment with ZON and a computerized psychotherapy platform called Take Control (TC); 2) treatment with a placebo (PLC) and TC. To understand the neurobiology behind ZON's potential therapeutic effects on AUD, fMRI will be used to compare the brain activity of the ZON+TC versus PLC+TC group while participants perform an alcohol and emotional-word Stroop task, as well as an alcohol related cues task.

NCT02901041
Conditions
  1. Alcohol Dependence
Interventions
  1. Drug: Zonisamide
  2. Behavioral: Take Control
  3. Drug: Placebo (for Zonisamide)
MeSH:Alcoholism

Primary Outcomes

Description: Drinking measures derived from Time Line Follow Back data will include the percent days drinking, the number of drinks consumed per day, and the percent days heavy drinking. Heavy drinking will be defined as 4 or more drinks per day for women and 5 or more drinks per day for men.

Measure: Alcohol Consumption

Time: Change from baseline following 12-week treatment

Secondary Outcomes

Description: The Risk Task (Rogers et al., 1999) measures decision-making under risk.

Measure: Risk Task - Risk Taking Behavior

Time: Change from baseline at conclusion of 12-week treatment

Description: The cued go no-go task (Fillmore, 2003) measures impulse control by the ability to inhibit instigated, "prepotent" responses.

Measure: Cued Go/No-go Task - Impulsivity

Time: Change from baseline at conclusion of 12-week treatment

Description: The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior. The BART models real-world risk behavior through the conceptual frame of balancing the potential for reward versus loss.

Measure: Balloon Analogue Risk Task - Risk Taking Behavior

Time: Change from baseline at conclusion of 12-week treatment

Description: The Continuous Performance Task (CPT) measures brain damage

Measure: Connors Continuous Performance Task - Impulsivity

Time: Change from baseline at conclusion of 12-week treatment
2 Development and Evaluation of Harm Reduction Talking Circles for Urban American Indians and Alaska Natives With Alcohol Use Disorders - Phase III Randomized Clinical Trial

This randomized clinical trial will compare participants who receive HaRTC versus the nontreatment control arm to see if HaRTC helps urban American Indians and Alaska Natives who meet criteria for an alcohol use disorder to increase their engagement in cultural practices, enhance their quality of life, and reduce their alcohol-related harm.

NCT04267692
Conditions
  1. Alcohol Use Disorder
Interventions
  1. Other: HaRTC
MeSH:Alcoholism Alcohol Drinking

Primary Outcomes

Description: Alcohol and Substance Use Frequency Assessment items were adapted from the Addiction Severity Index-Fifth Edition (ASI-5th Ed) and will be used to assess frequency of alcohol use in the past 30 days. Scores range from 0 to 30 with higher scores indicating more frequent drinking.

Measure: Change in Alcohol frequency

Time: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

Description: The Alcohol Quantity and Use Assessment was created by the research team for previous studies with a similar population and will be used to record the quantity of alcohol consumed on participants' heaviest, typical, and lightest drinking days in the past month. Scores are expressed in number of standard drinks with higher numbers indicating heavier drinking.

Measure: Change in Peak alcohol use

Time: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

Description: The Short Inventory of Problems-2nd Revision (SIP-2R), a psychometrically reliable and valid 15-item, Likert-scale questionnaire, measures social, occupational, and psychological problems related to alcohol use. Scores range from 0 to 45 with higher scores indicating more severe alcohol-related harm.

Measure: Change in Alcohol-related harm

Time: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

Description: The EuroQoL-5 Dimensional-5 Level is a widely used generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). Each domain is rated on a 5 point likert scale. Scores range from 5-25, with higher scores indicating poorer health related quality of life.

Measure: Change in EuroQoL-5 Dimensional-5 Level

Time: Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

Description: **Self-report data for cost-effectiveness analyses -The Non-Study Resources Form: documents change in medical and nonmedical resources used by participants.

Measure: Change in Cost effectiveness

Time: 6 months before study participation compared to 6 months after enrollment.

Description: Ethyl glucuronide (EtG) urine tests will be used to validate self-reported alcohol use at each assessment. EtG, a metabolite of ethyl alcohol formed in the body after ethanol exposure, reflects alcohol consumption over the previous 72 hours. EtG (cutoff 300 mg/nl) will serve as a secondary outcome in analyses.

Measure: Change in Ethyl glucuronide

Time: Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

Other Outcomes

Description: The Cultural Connectedness Scale is a 29-item Likert type measure consisting of 3 dimensions: identity, traditions, and spirituality. Scores can range from 29-145, with higher scores indicating a greater degree of cultural connectedness. Criterion validity was demonstrated with cultural connectedness dimensions adequately correlating with other indicators of wellness. The resulting scale scores will represent the proposed mediator in this study.

Measure: Change in Cultural connectedness

Time: Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
3 Isolated During COVID-19: Effects of COVID-19's Social Restrictions on Loneliness and Psychosocial Symptomatology

This study seeks to gather data and insight on epidemiologic trends of loneliness and other behaviors in the wake of the CDC recommended "social distancing" during the COVID-19 pandemic. The objective of this study is to use a cross-sectional survey to assess the impact of COVID-19's associated recommendations (social distancing, self-isolation, and self-quarantine) on loneliness and psychosocial symptomatology (depression, anxiety, substance abuse) on young adults (18-35 years old).

NCT04440098
Conditions
  1. Loneliness
  2. Depression
  3. Anxiety
  4. Alcohol Abuse
  5. Drug Abuse
MeSH:Alcoholism Substance-Related Disorders

Primary Outcomes

Description: University of California Los Angeles ( UCLA) Loneliness Scale is a 20-item self-report questionnaire that evaluates subjective feelings of loneliness and social isolation. Participants rate items on a 4-point Likert scale ranging from 1 (never) to 4 (often).Items are summed to create a score that can range from 20-80, higher scores being indicative of greater loneliness.

Measure: Loneliness as evaluated by the UCLA loneliness scale

Time: Day 1

Description: Alcohol Use Disorder Identification Test (AUDIT) is a 10-item self-reported questionnaire used to identify individuals whose alcohol consumption could be hazardous for their health. Participants rate items in a 5-point Likert scale, indicating amount (0 to 10 drinks or more), frequency (never to daily or almost daily), and indication of problems caused by alcohol (yes or no). Items were summed up to create a score that can range from 0 to 50. A score of 1 to 7 indicates low risk consumption, whereas a score of 8-15 suggests risky or hazardous drinking, a score of more than 15 is likely to indicate high-risk drinking and alcohol dependence.

Measure: Alcohol Use as evaluated by the AUDIT

Time: Day 1

Description: The Drug Abuse Screening Test (DAST-10) is a 10-item self-reported screening test that provides a quantitative index of the degree of consequences related to drug abuse. Participants rate items yes or no, positive responses corresponding to 1 point. Items are summed up to create a score that can range from 0-10. A score of 1-2 represents risky behaviors related to drugs, 3-5 represents moderate problems, 6-8 represents substantial problems, and 9-10 represents severe problems.

Measure: Drug Use as evaluated by the DAST-10

Time: Day 1

Description: The General Anxiety Disorder Scale (GAD- 7) is a 7- item self-reported screening tool that assess presence and severity of Generalized Anxiety Disorder. Participants rated frequency of problems in a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed up to create a score with scores of 5, 10, and 15 being the cut-off points for mild, moderate and severe anxiety, respectively.

Measure: Anxiety as evaluated by GAD-7

Time: Day 1

Description: The Center for Epidemiologic Studies Depression scale (CES-D-10) is a 10-item self-reported measure that assesses the frequency of symptoms of depression. Participants rate frequency of symptoms in a 4-point Likert scale from 0 (rare or none of the time) to 3 (most or almost all the time). Items are summed up to create a score that ranges from 0 to 30, with higher scores representing greater depressive symptoms. A score of 16 or more represents clinical depression.

Measure: Depression as assessed by CES-D-10

Time: Day 1
4 Woebot for Substance Use Disorders During COVID-19

The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic. This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.

NCT04460027
Conditions
  1. Substance Use Disorders
  2. Alcohol Use Disorder
Interventions
  1. Other: Woebot Substance Use Disorder
MeSH:Disease Alcoholism Substance-Related Disorders

Primary Outcomes

Measure: Change of number of days drinking

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Change of number of days drug use

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Secondary Outcomes

Measure: Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (AUDADIS-5 (AUDADIS-V)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Short Inventory of Problems - Alcohol and Drugs (SIP-AD)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Drug Abuse Screening Test (DAST-10)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Brief Situational Confidence Questionnaire (BSCQ)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Craving rating

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Range from 0-100 (no pain to worst pain imaginable)

Measure: Pain rating

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Total score between 0-27, higher scores indicate greater levels of depression

Measure: Patient Health Questionnaire-9 (PHQ-9)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Total score between 0-21, higher scores indicate greater levels of anxiety

Measure: General Anxiety Disorder-7 (GAD-7)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: CAIR Pandemic Impact Questionnaire (CAIR-PIQ)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Range from 8 to 32, with higher values indicating higher satisfaction

Measure: Client Satisfaction Questionnaire (CSQ)

Time: Post-treatment (8 weeks from baseline)

Measure: Usage Rating Profile Intervention (URPI)

Time: Post-treatment (8 weeks from baseline)
5 Extension and Online Adaptation of the FITSTART Parent-based Intervention to Reduce Drinking Among First-year Students

FITSTART (Feedback Intervention Targeting Student Transitions and Risk Trajectories) is a parent-based social norms intervention that has been shown to reduce risky drinking in incoming first year students.This program uses normative feedback to correct parents overestimation of other parents negative alcohol-related parenting practices (e.g., number of drinks parents would permit their college student to consume). Theory and research suggests that correcting those common misperceptions can motivate parents to adjust their own behaviors (e.g., reducing the number of drinks they would permit), which, in turn, can impact college student drinking. Despite FITSTARTs success, the design of the program limits participation to only students who have parents who can attend on-campus orientation sessions during the summer months before the start of the Fall semester. To address this limitation and extend the previous work, the proposed randomized clinical trial (RCT) will evaluate the efficacy of an online adaptation of the FITSTART(+) PBI program. To examine the efficacy of the newly developed FITSTART+ PBI web app, the proposed RCT will use a longitudinal design to examine if students self-report drinking and related negative consequences during their first semester in college significantly differed between FITSTART+ PBI (intervention app) and a control version of the app. Self-reported drinking and consequences are expected to be lower amongst students with parents randomized to FITSTART+ PBI relative to those with parents randomized to the control app.

NCT04549454
Conditions
  1. Alcohol Drinking
  2. Alcohol Problem Drinking
  3. Parenting
Interventions
  1. Behavioral: FITSTART+ PBI
  2. Behavioral: General Parenting Advice
MeSH:Alcoholism Alcohol Drinking

Primary Outcomes

Description: Assesses number of drinks consumed during an average week over the past month

Measure: Change from Baseline Daily Drinking at 1 Month

Time: baseline, 1 month

Description: Assesses number of drinks consumed during an average week over the past month.

Measure: Change from Baseline Daily Drinking at 3 Months

Time: baseline, 3 months

Description: Assesses reported frequency of negative alcohol outcomes over the past month

Measure: Change from Baseline Frequency of Alcohol Consequences at 1 Month

Time: baseline, 1 month

Description: Assesses reported frequency of negative alcohol outcomes over the past month

Measure: Change from Baseline Frequency of Alcohol Consequences at 3 Months

Time: baseline, 3 months

Description: Assesses frequency and quantity of alcohol consumption over the past month

Measure: Change from Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month

Time: baseline, 1 month

Description: Assesses frequency and quantity of alcohol consumption over the past month

Measure: Change from Baseline Quantity/Frequency/Peak Alcohol Use at 3 Months

Time: baseline, 3 months

Description: Assesses frequency heavy episodic drinking events over the past month

Measure: Change from Baseline heavy episodic drinking at 1 Month

Time: baseline, 1 month

Description: Assesses frequency heavy episodic drinking events over the past month

Measure: Change from Baseline heavy episodic drinking at 3 Months

Time: baseline, 3 months
6 Single-dose Interventions to Reduce Re-admissions for Hospitalized Patients With Refractory Alcohol Use Disorder: A Randomized Pilot Feasibility Study.

Every year, alcohol use disorder (AUD) generates millions of emergency department (ED) visits and hospital admissions, costing the U.S. health sector over $90 billion. These hospital admissions are critical opportunities to start patients on addiction pharmacotherapy, but factors like medication non-adherence and post-discharge relapse contribute to frequent re-admissions. Two single-dose interventions are well suited to facilitate treatment retention and prevent re-admissions due to their prolonged, adherence-independent effects: extended-release (XR) naltrexone injection and intravenous (IV) ketamine infusion. These have not been thoroughly investigated in the hospital setting among high-utilizer, safety-net populations. Therefore, the investigators aim to: 1. Test the feasibility of randomizing hospitalized patients (n=45-60, age 18-65) with multiple AUD-related admissions to treatment with either extended-release (XR) naltrexone, intravenous (IV) ketamine, or no single-dose medication, all with enhanced linkage to care. Feasibility outcomes such as recruitment rate, patient acceptability, post-discharge follow-up rate, and adverse events will help to identify key lessons for a future comparative effectiveness study. 2. Estimate the 30-day re-admission rate for patients randomized to treatment with XR naltrexone, with IV ketamine, or no single-dose medication, all with enhanced linkage to care. The investigators hypothesize that the re-admission rate will be lower for each of the two single-dose medication groups than for the "linkage-alone" group.

NCT04562779
Conditions
  1. Alcohol Use Disorder, Severe
Interventions
  1. Drug: Naltrexone 380 MG
  2. Drug: Ketamine Hydrochloride
  3. Behavioral: Enhanced linkage
MeSH:Alcoholism Alcohol Drinking

Primary Outcomes

Description: Binary outcome: any all-cause hospitalization ascertained by chart review (our EHR includes records from several local hospitals)

Measure: Rate (%) of 30-day hospital re-admission

Time: Within 30 days of index hospital discharge. The enrollment period is 5 months.

Description: Number of participants recruited per month during the enrollment period

Measure: Feasibility - recruitment rate (# per month)

Time: The enrollment period is 5 months

Description: Percentage of patients who presented to 1 week follow-up appointment

Measure: Feasibility - follow-up rate (%)

Time: The enrollment period is 5 months

Secondary Outcomes

Description: Within-subject differences in readiness to change between inpatient enrollment and outpatient follow-up.

Measure: Average within-subject difference in readiness-to-change (SOCRATES-8A score)

Time: Follow-up planned to be within one week of discharge

Description: Binary outcome: any all-cause ED visit ascertained by chart review

Measure: Rate (%) of 30-day emergency department visit

Time: Within 30 days of index hospital discharge. The enrollment period is 5 months.

Description: Obtained by urine EtG at outpatient follow-up

Measure: Rate (%) of urine Ethyl Glucuronide (EtG) at follow-up

Time: Follow-up planned to be within one week of discharge. The enrollment period is 5 months.

Description: Self reported at outpatient follow-up, ascertained by Timeline Follow-Back Method.

Measure: Rate (%) of self-reported binge drinking since discharge

Time: Follow-up planned to be within one week of discharge. The enrollment period is 5 months.
7 The Effects of the Histamine-3 Receptor Inverse Agonist Pitolisant on Alcohol Self-Administration in Heavy Drinkers

This is a double-blind, randomized, placebo-controlled, crossover design trial that will test the effect of pitolisant on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this proposal is to determine whether pitolisant has effects on alcohol consumption and craving

NCT04596267
Conditions
  1. Alcohol Use Disorder
  2. Alcohol Drinking
Interventions
  1. Drug: Pitolisant
  2. Drug: Placebo
MeSH:Alcoholism Alcoholic Intoxication Alcohol Drinking

Primary Outcomes

Description: Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was not consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.

Measure: Alcohol Consumption

Time: 2.6 hours

Description: Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving and the other end meaning intense alcohol craving. The Participant marks a point on the line that matches their amount of alcohol craving.

Measure: Alcohol Craving

Time: 2.6 hours

Description: The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly disagree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Lower scores are associated with less urge for an alcoholic drink.

Measure: Alcohol Urge

Time: 2.6 hours

Secondary Outcomes

Description: Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively.

Measure: Alcohol-induced stimulation

Time: 2.6 hours

Description: The Visual Analog Scale (VAS) will be used to assess alcohol craving during the medication exposure period. The VAS is a 10 cm straight line with one end meaning no alcohol craving and the other end meaning intense alcohol craving. Higher scores are associated with more cravings.

Measure: Alcohol craving during 4-day drug exposure

Time: 4 days

Description: Alcohol consumption during the 4 days of drug exposure will be measured using the timeline followback method

Measure: Alcohol consumption during the 4-day drug exposure

Time: 4 days
8 Use of CBD Oil for Reducing the Negative Emotional Impact of COVID-19: A Randomized Placebo-Controlled Clinical Trial

The overarching objective of the proposed project is to test the relative clinical efficacy of CBD isolate, full-spectrum CBD oil, and placebo in in reducing COVID-Induced stress, anxiety, depression, anger, and sleep disturbance.

NCT04603781
Conditions
  1. Anxiety Depression
  2. Alcohol Abuse
  3. Substance Abuse
  4. Anger
  5. Sleep Disturbance
  6. Stress Reaction
Interventions
  1. Dietary Supplement: CBD Isolate
  2. Dietary Supplement: Full Spectrum CBD Oil
  3. Dietary Supplement: Placebo Oil
MeSH:Dyssomnias Parasomnias Substance-Related Disorders Alcoholism Fractures, Stress

Primary Outcomes

Description: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Emotional Distress Index

Time: Week 0-Baseline

Description: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Emotional Distress Index

Time: Week 1-Treatment

Description: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Emotional Distress Index

Time: Week 2-Treatment

Description: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Emotional Distress Index

Time: Week 3-Treatment

Description: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Emotional Distress Index

Time: Weeks 4-Treatment

Description: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Emotional Distress Index

Time: Week 5-Treatment

Description: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Emotional Distress Index

Time: Week 6-Treatment

Description: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Emotional Distress Index

Time: Week 7-Follow-up

Description: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Emotional Distress Index

Time: Week 8-Follow-up

Secondary Outcomes

Description: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Depression Scale

Time: Week 0-Baseline

Description: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Depression Scale

Time: Week 1-Treatment

Description: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Depression Scale

Time: Week 2-Treatment

Description: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Depression Scale

Time: Week 3-Treatment

Description: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Depression Scale

Time: Week 4-Treatment

Description: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Depression Scale

Time: Week 5-Follow-up

Description: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Depression Scale

Time: Week 6-Follow-up

Description: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anxiety Scale

Time: Week 0 Baseline

Description: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anxiety Scale

Time: Week 1-Treatment

Description: This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anxiety Scale

Time: Week 2-Treatment

Description: This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anxiety Scale

Time: Week 3-Treatment

Description: This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anxiety Scale

Time: Week 4-Treatment

Description: This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anxiety Scale

Time: Week 5-Follow-up

Description: This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anxiety Scale

Time: Week 6-Follow-up

Description: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anger Scale

Time: Week 0 Baseline

Description: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anger Scale

Time: Week 1 Treatment

Description: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anger Scale

Time: Week 2 Treatment

Description: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anger Scale

Time: Week 3 Treatment

Description: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anger Scale

Time: Week 4 Treatment

Description: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anger Scale

Time: Week 5 Follow-up

Description: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Anger Scale

Time: Week 6 Follow-up

Description: This measure is an 8-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Alcohol Negative Consequences Scale

Time: Week 0 Baseline

Description: This measure is an 8-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Alcohol Negative Consequences Scale

Time: Week 1 Treatment

Description: This measure is an 8-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Alcohol Negative Consequences Scale

Time: Week 2 Treatment

Description: This measure is an 8-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

Measure: PROMIS Alcohol Negative Consequences Scale

Time: Week 3 Treatment

Description: This measure is an 8-item patient-rated index of substance use severity. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Almost Always).

Measure: PROMIS Alcohol Negative Consequences Scale

Time: Week 4 Treatment

Description: This measure is an 8-item patient-rated index of substance use severity. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Almost Always).

Measure: PROMIS Alcohol Negative Consequences Scale

Time: Week 5 Follow-up

Description: This measure is an 8-item patient-rated index of substance use severity. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Almost Always).

Measure: PROMIS Alcohol Negative Consequences Scale

Time: Week 6 Follow-up

Description: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

Measure: PROMIS Sleep Disturbance Scale

Time: Week 0 Baseline

Description: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

Measure: PROMIS Sleep Disturbance Scale

Time: Week 1 Treatment

Description: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

Measure: PROMIS Sleep Disturbance Scale

Time: Week 2 Treatment

Description: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

Measure: PROMIS Sleep Disturbance Scale

Time: Week 3 Treatment

Description: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

Measure: PROMIS Sleep Disturbance Scale

Time: Week 4 Treatment

Description: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

Measure: PROMIS Sleep Disturbance Scale

Time: Week 5 Follow-up

Description: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

Measure: PROMIS Sleep Disturbance Scale

Time: Week 6 Follow-up

Description: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

Measure: COVID-19 Coping Self-Efficacy

Time: Week 0 Baseline

Description: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

Measure: COVID-19 Coping Self-Efficacy

Time: Week 1 Treatment

Description: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

Measure: COVID-19 Coping Self-Efficacy

Time: Week 2 Treatment

Description: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

Measure: COVID-19 Coping Self-Efficacy

Time: Week 3 Treatment

Description: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

Measure: COVID-19 Coping Self-Efficacy

Time: Week 4 Treatment

Description: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

Measure: COVID-19 Coping Self-Efficacy

Time: Week 5 Follow-up

Description: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

Measure: COVID-19 Coping Self-Efficacy

Time: Week 6 Follow-up

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on December 13, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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