Development of Ivermectin for Alcohol Use Disorders

NCT ID: NCT02046200

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-03-31

Brief Summary

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.

Detailed 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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ivermectin

Ivermectin 30 mg single dose

Group Type: EXPERIMENTAL

Ivermectin

Intervention Type: DRUG

Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin.

Alcohol

Intervention Type: DRUG

Sugar pill

Matched placebo, single dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo

Alcohol

Intervention Type: DRUG

Interventions

Ivermectin

Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin.

Intervention Type: DRUG

Placebo

Matched placebo

Intervention Type: DRUG

Alcohol

Intervention Type: DRUG

Other Intervention Names

Stromectol; Sugar pill; 5% ethanol IV solution

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Lara Ray, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lara Ray, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Daniel Roche, PhD

Role: STUDY_DIRECTOR

University of California, Los Angeles

Locations

UCLA Addictions Laboratory

Los Angeles, California, United States

Countries

United States

Related Links

http://addictions.psych.ucla.edu

UCLA Addictions Laboratory

Other Identifiers

UL1TR000124

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IVM

Identifier Type: -

Identifier Source: org_study_id