Development of Ibudilast for Alcohol Use Disorder

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ibudilast

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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