Development of Ivermectin for Alcohol Use Disorders



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 65
Updated:8/10/2018
Start Date:February 2014
End Date:March 2015

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Repositioning Ivermectin for the Treatment of Alcohol Use Disorders

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.

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.

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.
We found this trial at
1
site
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
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