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D000428: Alcohol Drinking

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 (25)


Name (Synonyms) Correlation
drug421 Attention Control Text Messaging Wiki 0.35
drug488 BCG vaccine (Freeze-dried) Wiki 0.35
drug3194 Pitolisant Wiki 0.35
Name (Synonyms) Correlation
drug1614 FITSTART+ PBI Wiki 0.35
drug485 BCG GROUP Wiki 0.35
drug3592 Real-time chat-based support through IM Apps Wiki 0.35
drug2270 Ketamine Hydrochloride Wiki 0.35
drug486 BCG Vaccine Wiki 0.35
drug266 Alcohol brief intervention Wiki 0.35
drug1779 General health through IM Apps Wiki 0.35
drug3050 PLACEBO GROUP Wiki 0.35
drug467 BAT2020 Wiki 0.35
drug1776 General Parenting Advice Wiki 0.35
drug2746 Naltrexone 380 MG Wiki 0.35
drug4835 attendance by ambulance crew Wiki 0.35
drug1509 Enhanced linkage Wiki 0.35
drug1847 HaRTC Wiki 0.35
drug487 BCG vaccine Wiki 0.35
drug29 12-page health warning leaflet Wiki 0.35
drug3620 Regular messages through Instant Messaging (IM) Wiki 0.35
drug739 CBT Text Messaging Wiki 0.35
drug157 AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong Wiki 0.35
drug490 BCG-Denmark Wiki 0.20
drug3844 Saline Wiki 0.11
drug3195 Placebo Wiki 0.06

Correlated MeSH Terms (6)


Name (Synonyms) Correlation
D000435 Alcoholic Intoxication NIH 0.50
D000437 Alcoholism NIH 0.50
D019973 Alcohol-Related Disorders NIH 0.35
Name (Synonyms) Correlation
D000374 Aggression NIH 0.35
D013315 Stress, Psychological NIH 0.12
D004630 Emergencies NIH 0.06

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0000718 Aggressive behavior HPO 0.35

Clinical Trials

Navigate: Correlations   HPO

There are 8 clinical trials


1 Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students: a Pragmatic Randomized Controlled Trial

This study aims to assess the effect of personalized support using instant messaging application on alcohol drinking reduction in university students proactively recruited from universities in Hong Kong.

NCT04025151
Conditions
  1. Alcohol Misuse
Interventions
  1. Behavioral: Alcohol brief intervention
  2. Behavioral: 12-page health warning leaflet
  3. Behavioral: Regular messages through Instant Messaging (IM)
  4. Behavioral: Real-time chat-based support through IM Apps
  5. Behavioral: General health through IM Apps
  6. Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong
MeSH:Alcohol Drinking

Primary Outcomes

Description: Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 6-month after baseline.

Measure: Amount of alcohol consumption per week (gram/week) at 6-month follow-up

Time: 6-month after baseline

Description: To estimate large, moderate and null (same as the control) treatment effects and check whether ITT, AP and PP analysis estimates are biased compared with CACE estimates (alcohol consumption per week at 6-month follow-up)

Measure: Compare the primary outcome using intention-to-treat (ITT), per-protocol (PP) and as-treated (AP) analysis with Compliance Average Causal Effect (CACE) analysis

Time: 6-month after baseline

Secondary Outcomes

Description: Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 12-month after baseline.

Measure: Amount of alcohol consumption per week (gram/week) at 12-month follow-up

Time: 12-month after baseline

Description: Assessed by Alcohol Use Disorders Identification Test (ranged 0-40 with higher score indicating problematic alcohol use) and compare the AUDIT between intervention and control group at 6-month after baseline.

Measure: AUDIT scores at 6-month follow-up

Time: 6-month after baseline

Description: Assessed by Alcohol Use Disorders Identification Test (ranged 0-40 with higher score indicating problematic alcohol use) and compare the AUDIT between intervention and control group at 12-month after baseline.

Measure: AUDIT scores at 12-month follow-up

Time: 12-month after baseline

Description: Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 6-month

Measure: Number of standard drinks (10g of alcohol) per week at 6-month follow-up

Time: 6-month after baseline

Description: Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 12-month

Measure: Number of standard drinks (10g of alcohol) per week at 12-month follow-up

Time: 12-month after baseline

Description: Defined by 5 standard drink [male] or 4 standard drink [female] in one occasion for binge drinking and compare the episode of binge drinking between intervention group and control at baseline and 6-month follow-up questionnaires

Measure: Episode of binge drinking in the past 30-day at 6-month follow up

Time: at 6-month after baseline

Description: Defined by 5 standard drink [male] or 4 standard drink [female] in one occasion for binge drinking and compare the episode of binge drinking between intervention group and control at baseline and 12-month follow-up questionnaires

Measure: Episode of binge drinking in the past 30-day at 12-month follow up

Time: at 12-month after baseline

Description: Defined by 15 standard drink [male] or 8 standard drink[female] in a week for heavy drinking and compare the episode of heavy drinking between intervention group and control at baseline and 6-month follow-up questionnaires

Measure: Episode of heavy drinking in the past 30-day at 6-month follow up

Time: at 6 -month after baseline

Description: Defined by 15 standard drink [male] or 8 standard drink [female] in a week for heavy drinking and compare the episode of heavy drinking between intervention group and control at baseline and 12-month follow-up questionnaires

Measure: Episode of heavy drinking in the past 30-day at 12-month follow up

Time: at 12-month after baseline

Description: Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 6-month follow-up questionnaires

Measure: Planned drinking measured in the coming 30-day at 6-month follow up

Time: at 6-month after baseline

Description: Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 12-month follow-up questionnaires

Measure: Planned drinking measured in the coming 30-day at 12-month follow up

Time: at 12-month after baseline

Description: The four items in this scale addressed the number of times the student had been 'late to class', 'missed class', was 'unable to concentrate' and 'failed to complete assignment' (score range 0-16). The responses included 'not at all', 'once', 'twice', 'three times' and 'four times or more'. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires

Measure: Academic Role Expectation and Alcohol Scale at 6-month follow-up

Time: at 6-month after baseline

Description: The four items in this scale addressed the number of times the student had been 'late to class', 'missed class', was 'unable to concentrate' and 'failed to complete assignment' (score range 0-16). The responses included 'not at all', 'once', 'twice', 'three times' and 'four times or more'. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires

Measure: Academic Role Expectation and Alcohol Scale at 12-month follow-up

Time: at 12-month after baseline

Description: The 14-item measure of alcohol-related personal, social, sexual, and legal problems (eg, being physically aggressive toward someone while under the influence of alcohol).The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires

Measure: Alcohol Problems Scale at 6-month follow-up

Time: at 6-month after baseline

Description: The 14-item measure of alcohol-related personal, social, sexual, and legal problems (eg, being physically aggressive toward someone while under the influence of alcohol).The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires

Measure: Alcohol Problems Scale at 12-month follow-up

Time: at 12- month after baseline

Description: Mediation analysis of 6-month factors (knowledge of alcohol drinking, perception of alcohol drinking, intention to quit drinking, mental health) on weekly amount of alcohol consumption at 12-month

Measure: Mediation analysis of variables at 6-month on weekly amount of alcohol consumption at 12-month

Time: at 12- month after baseline

Description: Subgroup analysis to check whether the intervention is more effective with participants with intention to quit/reduce drinking on outcomes

Measure: Subgroup analysis of baseline intention to quit/reduce drinking

Time: at 12- month after baseline

Description: The conversations between the participants and the nurse will be analyzed and categorized into different sub-type of BCT taxonomy

Measure: Content analysis of IM Apps conversation using alcohol BCT taxonomy

Time: at 12- month after baseline

Description: Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires

Measure: Patient Health Questionnaire 4-item (PHQ-4) at 6-month

Time: at 6-month after baseline

Description: Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires

Measure: Patient Health Questionnaire 4-item (PHQ-4) at 12-month

Time: at 12-month after baseline

Description: Subjects' responses are measured on a five-point scale (0 = never, 1 = almost never, 2 =sometimes, 3 = fairly often, 4 = very often). Scoring: PSS-4 scores are obtained by summing across all four items. Scoring items 2 and 3 require reverse coding. This involves assigning the opposite score. For example, a score of 0=4, 1=3, 2=2, 3=1, and 4=0. The higher the score, the more perceived stress. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires

Measure: Perceived Stress Scale 4-item (PSS-4) at 6-month

Time: at 6-month after baseline

Description: Subjects' responses are measured on a five-point scale (0 = never, 1 = almost never, 2 =sometimes, 3 = fairly often, 4 = very often). Scoring: PSS-4 scores are obtained by summing across all four items. Scoring items 2 and 3 require reverse coding. This involves assigning the opposite score. For example, a score of 0=4, 1=3, 2=2, 3=1, and 4=0. The higher the score, the more perceived stress. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires

Measure: Perceived Stress Scale 4-item (PSS-4) at 12-month

Time: at 12-month after baseline

Description: Score ranges from 0 to 10 with higher score indicates a higher level of usefulness of our intervention.

Measure: Perceived usefulness of IM app intervention at 12-month

Time: at 12-month after baseline

Description: Ask for intention to use (yes/no) IM app intervention to reduce/quit drinking at 12-month

Measure: Intention to continue using IM app intervention at 12-month

Time: at 12-month after baseline

Description: Perceived difficulty, confidence and importance of quitting/reducing to drink will be asked. Score ranges from 0 to 10 with higher score indicates a high level. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires

Measure: Self-efficacy to reduce/quit drinking at 6-month

Time: at 6-month after baseline

Description: Perceived difficulty, confidence and importance of quitting/reducing to drink will be asked. Score ranges from 0 to 10 with higher score indicates a high level. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires

Measure: Self-efficacy to reduce/quit drinking at 12-month

Time: at 12-month after baseline

Description: Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic

Measure: Covid-19 related drinking behavioral changes at baseline

Time: at baseline

Description: Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic. The changes will be compared between the intervention group and control group at 6-month

Measure: Covid-19 related drinking behavioral changes at 6-month

Time: at 6-month

Description: Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic. The changes will be compared between the intervention group and control group at 12-month

Measure: Covid-19 related drinking behavioral changes at 12-month

Time: at 12-month
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 COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study

Background: The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global threat to people, communities, and health systems. Researchers are concerned about the mental health effects of the pandemic. They want to learn more about how it is affecting people s alcohol use and problems, and how it may continue to affect them over time. Objective: To study the impact of the COVID-19 pandemic on alcohol use and consequences in individuals across the spectrum of alcohol use and those with alcohol use disorder. Eligibility: Participants who have been screened under the NIAAA Screening, Assessment and Management Protocol (14-AA-0181) Design: Participants will complete a baseline survey by phone. It will ask about alcohol use, alcohol dependence, and stress. It covers 2 time periods: the 12 months before the pandemic started and the time since it started. Participants will get an ID code and a link to an online survey. They will complete the online survey within a week of the phone survey. Participants will complete a series of online surveys over 24 months. For the first year, surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8 weeks, and then every 1-2 months for the rest of the year. For the second year, surveys will be completed every 6 months. Surveys will cover the following topics: - Alcohol use and its consequences - Other substance use - Stress - Impact of the COVID-19 pandemic - Pain - Physical health - Sleep - Quality of life. Because the course of the pandemic may change, the frequency of the surveys may change. Participation lasts 2 years.

NCT04391816
Conditions
  1. Alcohol Drinking
  2. Alcohol-Related Disorders
  3. Pandemic
  4. Psychological Stress
MeSH:Alcohol-Related Disorders Alcohol Drinking Stress, Psychological

Primary Outcomes

Description: Alcohol Use Disorder Identification Test (AUDIT): This is a 10-item questionnaire designed to screen for AUD. The first 3 questions constitute the AUDIT-C and provides a measure of alcohol consumption. The total score provides a continuous quantification of AUD severity.

Measure: AUDIT Score

Time: 24 months

Description: Alcohol Dependence Scale (ADS): This 25-item scale will be used to measure severity of alcohol dependence. This scale covers alcohol withdrawal symptoms, impaired control over drinking, awareness of a compulsion to drink, increased tolerance to alcohol, and salience of drink-seeking behavior.

Measure: ADS Score

Time: 24 months

Secondary Outcomes

Description: Life Events Questionnaire (LEQ): This questionnaire assesses positive and negative life events and their impact on participants

Measure: Life Events Questionnaire (LEQ) Score

Time: 24 monhts

Description: UCLA Loneliness Scale (UCLALS): This is a 20-item scale designed to measure a person s subjective feeling of loneliness and social isolation in the last month

Measure: UCLA Loneliness Scale (UCLALS) Score

Time: 24 months

Description: Perceived stress scale (PSS): This is a 10-item scale to measure perception of stress

Measure: Perceived Stress Scale (PSS) Score

Time: 24 months
4 Ambulance Calls for Substance Use and Alcohol in a Pandemic (ASAP): Exploring Attendance at Incidents Involving Substance and/or Alcohol Use During COVID-19 Pandemic

The Primary objective is to explore ambulance service attendance at incidents involving alcohol and/or substance use over the period of the pandemic lockdown, and the following months. This will be to determine prevalence and explore factors such as patient gender, age, ethnicity or location. Analysis will examine the calls over the course of the year prior to the lockdown, and then compare this to the period of lockdown and following months.

NCT04474444
Conditions
  1. Alcohol Use, Unspecified
  2. Substance Use
  3. Intoxication Alcohol
  4. Emergencies
  5. COVID-19 Pandemic
  6. Treatment
Interventions
  1. Other: attendance by ambulance crew
MeSH:Emergencies Alcoholic Intoxication Alcohol Drinking

Primary Outcomes

Description: Counts of attendances for alcohol and drug use by the East Midland's Ambulance Service over the time period. This will be a number per day of people attended.

Measure: Attendances for alcohol and drug use

Time: Full data set 23/03/2019 compared to 22/03/2021 to look at interruption (lockdown) in the time series.
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 Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence

We will recruit sexual and gender minority couples to complete 56 days of daily surveys in order to evaluate (1) the impact of COVID-19 stress and sexual and gender minority stress on heavy episodic drinking and intimate partner violence (IPV) perpetration, and (2) a brief, mobile-phone delivered text messaging intervention to mitigate the effects of these stressors. This project has high potential to inform how pandemic stress contributes to etiological models of alcohol-related IPV perpetration in sexual and gender minority couples and inform a culturally-sensitive, low burden, and easy to disseminate intervention to mitigate these effects critical during a pandemic when access to care is limited.

NCT04625465
Conditions
  1. Alcohol Consumption
  2. Violence, Domestic
  3. Stress, Psychological
  4. Aggression
Interventions
  1. Behavioral: CBT Text Messaging
  2. Behavioral: Attention Control Text Messaging
MeSH:Aggression Alcohol Drinking Stress, Psychological
HPO:Aggressive behavior

Primary Outcomes

Description: Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.

Measure: Intimate Partner Violence Events (Burst 1)

Time: Burst 1, Daily for 14 days

Description: Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.

Measure: Intimate Partner Violence Events (Burst 2)

Time: Burst 2, Daily for 14 days

Description: Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.

Measure: Intimate Partner Violence Events (Burst 3)

Time: Burst 3, Daily for 14 days

Description: Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.

Measure: Intimate Partner Violence Events (Burst 4)

Time: Burst 4, Daily for 14 days

Description: Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.

Measure: Drinking Episodes (Burst 1)

Time: Burst 1, Daily for 14 days

Description: Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.

Measure: Drinking Episodes (Burst 2)

Time: Burst 2, Daily for 14 days

Description: Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.

Measure: Drinking Episodes (Burst 3)

Time: Burst 3, Daily for 14 days

Description: Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.

Measure: Drinking Episodes (Burst 4)

Time: Burst 4, Daily for 14 days

Secondary Outcomes

Description: Participants will be asked if they experienced discrimination related to their sexual or gender identity.

Measure: Sexual or Gender Minority Stress (Burst 1)

Time: Burst 1, Daily for 14 days

Description: Participants will be asked if they experienced discrimination related to their sexual or gender identity.

Measure: Sexual or Gender Minority Stress (Burst 2)

Time: Burst 2, Daily for 14 days

Description: Participants will be asked if they experienced discrimination related to their sexual or gender identity.

Measure: Sexual or Gender Minority Stress (Burst 3)

Time: Burst 3, Daily for 14 days

Description: Participants will be asked if they experienced discrimination related to their sexual or gender identity.

Measure: Sexual or Gender Minority Stress (Burst 4)

Time: Burst 4, Daily for 14 days

Description: Participants will be asked if they experienced stress related to the COVID-19 pandemic.

Measure: COVID-19 Stress (Burst 1)

Time: Burst 1, Daily for 14 days

Description: Participants will be asked if they experienced stress related to the COVID-19 pandemic.

Measure: COVID-19 Stress (Burst 2)

Time: Burst 2, Daily for 14 days

Description: Participants will be asked if they experienced stress related to the COVID-19 pandemic.

Measure: COVID-19 Stress (Burst 3)

Time: Burst 3, Daily for 14 days

Description: Participants will be asked if they experienced stress related to the COVID-19 pandemic.

Measure: COVID-19 Stress (Burst 4)

Time: Burst 4, Daily for 14 days

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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