Development of Ivermectin for Alcohol Use Disorders

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Alcohol Use Disorder

Treatments: Drug: Placebo; Drug: Ivermectin; Drug: Alcohol

Study type: Interventional

Funder types: Other

Identifiers

NCT02046200

UL1TR000124 (U.S. NIH Grant/Contract)

IVM

Details and patient eligibility

About

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.

Full description

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. We will enroll 10 alcohol dependent individuals in a placebo-controlled randomized pilot safety trial of IVM (30 mg orally once) over a 2-day (1-night) inpatient stay at the UCLA CTRC and employ a well-characterized battery of behavioral paradigms (i.e., alcohol administration and cue exposure). The goals of the study are to test: (a) the safety of combining IVM, at a dose currently shown to be safe in humans (30 mg), with moderate doses of alcohol (0.08 g/dl); and (b) whether IVM reduces the reinforcing effects of alcohol during alcohol administration and whether it reduces alcohol craving during cue exposure, as compared to placebo.

Enrollment: 11 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 21 and 65;
• meet current DSM-V diagnostic criteria for an alcohol use disorder

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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11 participants in 2 patient groups, including a placebo group

Ivermectin

Experimental group

Description:

Ivermectin 30 mg single dose

Treatment:

Drug: Alcohol

Drug: Ivermectin

Sugar pill

Placebo Comparator group

Description:

Matched placebo, single dose

Treatment:

Drug: Alcohol

Drug: Placebo