Development of Ivermectin for Alcohol Use Disorders
Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Use Disorder
Intervention: Ivermectin (Drug); Placebo (Drug); Alcohol (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: University of California, Los Angeles Official(s) and/or principal investigator(s): Lara Ray, PhD, Principal Investigator, Affiliation: University of California, Los Angeles Daniel Roche, PhD, Study Director, Affiliation: University of California, Los Angeles
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.
Clinical Details
Official title: Repositioning Ivermectin for the Treatment of Alcohol Use Disorders
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Heart rate, blood pressure (Safety)Subjective effects using the Alcohol urge questionnaire (AUQ), Drug Effects Questionnaire, and Biphasic Alcohol Effects Scale (BAES) Cue-induced craving using the Alcohol Urge Questionnaire (AUQ) Adverse effects scores on the SAFTEE
Secondary outcome: Stress-induced alcohol cravingIvermectin pharmacokinetics: peak concentration (Cmax) Ivermectin pharmacokinetics: time to Cmax (Tmax) Ivermectin pharmacokinetics: area under the time-concentration curve (AUC) Ivermectin pharmacokinetics: half-life
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
UCLA Addictions Laboratory, Los Angeles, California 90095, United States
Additional Information
UCLA Addictions Laboratory
Starting date: February 2014
Last updated: August 18, 2015
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