Status:
WITHDRAWN
Development of a Selective ALDH2 Inhibitor to Treat AUD
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Amygdala Neurosciences
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
Alcohol use disorder (AUD) represents a highly prevalent, costly, and often untreated condition in the United States. Pharmacotherapy offers a promising avenue for treating AUD and for improving clini...
Eligibility Criteria
Inclusion
- 21 years and older (adult, older adult);
- meeet DSM-5 diagnostic criteria for alcohol use disorder (moderate or severe);
- report drinking at least 48 standard drinks in a 30-day period, during the 90 days before enrollment.
Exclusion
- current treatment for alcohol problems;
- a history of treatment for alcohol problems in the 30 days before enrollment;
- currently seeking treatment for alcohol problems;
- current DSM-5 diagnosis of dependence on any psychoactive substances other than alcohol or nicotine;
- lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
- positive urine screen for narcotics, amphetamines, or sedative hypnotics;
- serious alcohol withdrawal symptoms as indicated by a score of ≥10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)
- pregnant, nursing, or refusal to use reliable birth control method (if female);
- medical condition that may interfere with safe study participation (e.g. unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes);
- AST, ALT, or GGT ≥ 3 times upper limit of normal;
- attempted suicide in the past 3 years and/or serious suicidal intention or plan in the past year;
- currently on prescription medication that contraindicates use of ANS-6637;
- other circumstances that, in the opinion of the investigators, compromises participant safety
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04311294
Start Date
April 1 2020
End Date
March 1 2022
Last Update
May 25 2021
Active Locations (1)
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1
UCLA Addictions Lab
Los Angeles, California, United States, 90095