Development of Ivermectin for Alcohol Use Disorders

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the development of effective treatments for AUDs represents an important public health objective. Repositioning, i.e. using existing approved drugs for other indications, represents a fast and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting that it may be useful in the treatment of AUDs in humans. The goal of this project is to provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to treat AUDs.

Key facts

Study ID

NCT02046200

Run by

University of California, Los Angeles

People needed

11

Starts

2014-02-01

Expected to finish

2015-03-01

Last updated by the study team

2018-08-08

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 current DSM-V diagnostic criteria for an alcohol use disorder

You may not qualify if…

• current treatment for alcohol problems, a history of treatment in the 30 days before enrollment or current treatment seeking;
• a current (last 12 months) DSM-V diagnosis of dependence on any psychoactive substances other than alcohol and nicotine;
• a 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);
• a 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;
• currently on prescription medication that contraindicates use of IVN;
• 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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