|drug1780||Ketamine Hydrochloride Wiki||0.45|
|drug2513||Placebo (for Zonisamide) Wiki||0.45|
|drug397||BI 1569912 Wiki||0.45|
|drug1393||General Parenting Advice Wiki||0.45|
|drug1279||FITSTART+ PBI Wiki||0.45|
|drug3726||Woebot Substance Use Disorder Wiki||0.45|
|drug1194||Enhanced linkage Wiki||0.45|
|drug2149||Naltrexone 380 MG Wiki||0.45|
|drug3369||Take Control Wiki||0.45|
|drug399||BI 474121 Wiki||0.32|
|D000428||Alcohol Drinking NIH||0.40|
|D019966||Substance-Related Disorders NIH||0.27|
There are 5 clinical trials
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.
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
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 damageMeasure: Connors Continuous Performance Task - Impulsivity Time: Change from baseline at conclusion of 12-week treatment
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).
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
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.
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 depressionMeasure: 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 anxietyMeasure: General Anxiety Disorder-7 (GAD-7) Time: Difference between baseline and post-treatment (8 weeks from baseline)
Description: Range from 8 to 32, with higher values indicating higher satisfactionMeasure: Client Satisfaction Questionnaire (CSQ) Time: Post-treatment (8 weeks from baseline)
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.
Description: Assesses number of drinks consumed during an average week over the past monthMeasure: 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 monthMeasure: 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 monthMeasure: 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 monthMeasure: 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 monthMeasure: 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 monthMeasure: Change from Baseline heavy episodic drinking at 1 Month Time: baseline, 1 month
Description: Assesses frequency heavy episodic drinking events over the past monthMeasure: Change from Baseline heavy episodic drinking at 3 Months Time: baseline, 3 months
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.
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 periodMeasure: Feasibility - recruitment rate (# per month) Time: The enrollment period is 5 months
Description: Percentage of patients who presented to 1 week follow-up appointmentMeasure: Feasibility - follow-up rate (%) Time: The enrollment period is 5 months
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 reviewMeasure: 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-upMeasure: 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.
Data processed on September 26, 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.Drug Reports MeSH Reports HPO Reports