Development of Ibudilast for Alcohol Use Disorder
Completed · Phase 1 · Has a placebo group
Conditions studied: Alcohol Use Disorders
In brief
The objective of this proposal is to advance medication development for alcoholism by conducting a safety and initial efficacy study of ibudilast, a neuroimmune modulator and phosphodiesterase inhibitor, for alcohol use disorders.
Key facts
- Study ID
- NCT02025998
- Run by
- University of California, Los Angeles
- People needed
- 24
- Starts
- 2013-12-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2016-02-23
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age between 21 and 65
- meet DSM-IV diagnostic criteria for alcohol abuse or dependence
- report drinking at least 48 standard drinks in a 30-day period, during the 90 days before enrollment
You may not qualify if…
- current treatment for alcohol problems, a history of treatment in the 30 days before enrollment or current treatment seeking;
- current (last 12 months) DSM-IV diagnosis of dependence on any psychoactive substances other than alcohol and nicotine;
- lifetime DSM-IV 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 ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R);
- pregnancy, nursing, or refusal to use reliable method of birth control (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 normal limit;
- 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 IBUD;
- any other circumstances that, in the opinion of the investigators, compromises participant safety
Where it is running
- UCLA Addictions Laboratory — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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