Alcohol Use clinical trials at UCLA
6 in progress, 2 open to eligible people
CM for Patients With ALD After Liver Transplant
open to eligible people ages 18-99
Alcohol associated liver disease (ALD) refers to liver injury, such as cirrhosis, that is caused by alcohol use. It affects 2 million adults in the U.S. and is now the leading cause of cirrhosis-related hospitalizations, cirrhosis- related deaths, and liver transplantation. Alcohol use disorder (AUD), the root cause of ALD, affects 15 million Americans each year. While research studies have shown that behavioral therapy and medications specific for alcohol use have helped people overcome their alcohol use disorder, there has not been enough information related to how successful these treatments are specifically for people with ALD. This study will look at a behavioral treatment called "contingency management" (CM) that has shown to be effective with people with other substance use disorders. CM is based on the principles of operant conditioning that involves offering prize-based or monetary incentives to patients with substance use disorders to reduce substance use. This study will look at the efficacy and acceptability of CM in patients who received a liver transplant and have evidence of recurrent alcohol use. The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant; 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual (TAU or control). Subjects will be asked to complete 12 study visits (including Screening and Baseline Visits) that will last 1 to 2 hours each depending on the visit. All visits will be completed via Zoom or by phone. Study staff will instruct participants on how to use Zoom, if necessary. During the Screening and Baseline Visits, subjects will be: 1) asked to provide a urine test and blood draw, 2) complete the SCID-5 AUD, a semi-structured interview guide for making the major DSM-5 diagnoses, 3) complete the Iowa Gambling Test which looks at decision-making skills, 4) complete a survey that looks at the subject's quality of life after liver transplant, 4) review how much alcohol the subject has consumed in the last 30 days, 5) and if the subject has received any current AUD treatments. Once the Screening and Baseline visits are completed, subjects will be randomized to either the CM group or the TAU group. During the weekly visits, subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit. All subjects will receive $20 for completing the visits. For those in the CM group, subjects will also receive a CM reward for negative urine and/or blood tests, depending on which results we receive first-with rewards ranging from $5 to $80 depending on the week. Additionally, during weeks 1, 5, and 10, those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility.
Los Angeles, California
Motivation for IV Alcohol Self-Administration in Humans
open to eligible people ages 21-65
The goal of this translational study is to understand different reasons why people between the ages of 21 and 65 with alcohol use disorder are motivated to self-administer alcohol. The main questions it aims to answer are: - How does a person's desire for a reward affect their motivation to self-administer alcohol? - How does a person's emotions affect their motivation to self-administer alcohol? - How does a person's cognitive functioning affect their motivation to self-administer alcohol? Participants will be asked to complete questionnaires about their mood, habits, and functioning and will complete an IV alcohol administration that will include pressing a button to receive additional doses of IV alcohol.
Los Angeles, California
Oral AFA-281 in Patients with Alcohol Use Disorder
Sorry, not yet accepting patients
This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain thresholds, anxiety, depression, and sleep.
Los Angeles, California
Alcoholic Liver Disease and the Gut Microbiome
Sorry, in progress, not accepting new patients
Background: Significant sex differences exist in regard to alcohol use disorder (AUD) and alcoholic liver disease (ALD). To date, no studies have examined the brain-gut-microbiome (BGM) axis (which is the relationship between the gut, brain, and the bacteria within the gut) and sex-differences in AUD and ALD. Aims: 1) Demonstrate baseline sex differences in the microbiome and metatranscriptome of AUD and ALD and correlate those differences to severity, 2) determine if these baseline sex differences predicts abstinence or ALD related outcomes, and 3) show how altering the microbiome can decrease the severity of AUD and ALD in a sexdependent manner. Hypothesis: Our project is aimed to explore the hypothesis that sex-related differences of the BGM axis in AUD and ALD explains the variation in patient severity and outcome by sex, and that alterations of the BGM axis can decrease the severity of AUD and ALD in a sex-dependent manner. Methods: A pilot randomized placebo (VSL#3 vs placebo) control trial will be performed in patients with AUD and ALD for 6 months. Questionnaire data, clinical labs, serum, and feces for shotgun metagenomics will be collected at baseline, 3-months, and 6-months. Anticipated Results: Patients with severe AUD/ALD will have more microbes and microbial genes associated with inflammation. These differences will predict outcomes at 6-months and that changes of this baseline microbiome with VSL#3 will lead to more positive outcomes than placebo, with men having greater benefit from VSL#3 than women. Implications and Future Studies: The discovery of the mechanisms underlying sex-related differences in AUD/ALD is needed for the development of personalized recommendations for prevention and treatment in men and women
Los Angeles, California
Suvorexant for Treatment of AUD and PTSD
Sorry, not yet accepting patients
This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.
Los Angeles, California and other locations
TACUNA (Traditions and Connections for Urban Native Americans)
Sorry, in progress, not accepting new patients
This study responds to Request For Application-DA-19-035, HEAL (Helping End Addiction Long Term) initiative: Preventing OUD in Older Adolescents and Young Adults (ages 16-30) by developing and implementing a culturally centered intervention to address opioid use among urban AI/AN emerging adults in California. The primary goal of this study is to compare AI/AN emerging adults who receive TACUNA plus a Wellness Circle (WC) to those AI/AN emerging adults who receive an opioid education workshop on outcomes (e.g., opioid misuse and alcohol and other drug use) over a period of 12 months. TACUNA will be a motivational interviewing group intervention that incorporates traditional practices and discussion of how to cultivate healthy social networks and cultural worlds. The Wellness gathering will be for emerging adults and people in their social network, and will focus on how social networks and cultural connectedness influence healthy behaviors. Opioid education will focus on discussion of opioid misuse within the AI/AN urban community and ways to reduce use in a culturally appropriate manner. Investigators expect those who receive TACUNA + WG will report less opioid and AOD (alcohol and other drug) use frequency, fewer consequences, less time spent around peers who use opioids and AOD, and less perceived prevalence of peer use compared to opioid education over a period of 12 months. Also, investigators will evaluate the intervention's effects on secondary outcomes of social networks and cultural connectedness. Survey data is collected at baseline, 3-months, 6-months and 12-months. Longitudinal analyses will compare intervention participant and control participants on primary and secondary outcomes.
Los Angeles, California and other locations
Our lead scientists for Alcohol Use research studies include Lara Ray, PhD, MA Arpan A. Patel, MD Tien S. Dong, MD.
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