Phase 2 N=11 Randomized Triple-blind Treatment

Development of Ivermectin for Alcohol Use Disorders

Alcohol Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02046200 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Heart Rate — 64.57; 68.36; 66.82; 62.82 BPM — p=0.0563

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ivermectin (Drug); Placebo (Drug); Alcohol (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Heart Rate	64.57; 68.36; 66.82; 62.82; 66.09; 64.27	0.0563
PRIMARY Systolic Blood Pressure	121; 111.64; 118.64; 117; 120.64; 116.27	0.0342 sig
PRIMARY Diastolic Blood Pressure	79.64; 75.55; 77.45; 75.18; 78.82; 74.91	0.1597
PRIMARY Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)	2.58; 2.90; 3.14; 3.27; 3.02; 3.19	0.7617
PRIMARY Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale	1.36; 0.91; 2.73; 3.45; 3.82; 4.82	0.93
PRIMARY Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale	4.09; 4.09; 5.36; 5.36; 6.18; 5.55	0.95
PRIMARY Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale	1.64; 3.18; 4.91; 6.27; 5.45; 6.00	0.43
PRIMARY Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale	0.91; 0.09; 2.64; 3.27; 4.00; 5.36	0.06
PRIMARY Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale	18.09; 17.36; 20.00; 23.73; 21.73; 20.09	0.21
PRIMARY Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale	14.18; 10.64; 11.00; 13.09; 10.91; 16.00	0.09
PRIMARY Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ)	3.59; 4.07	0.99
PRIMARY Adverse Effects	0; 1; 1; 0; 0; 0	—
SECONDARY Ivermectin Pharmacokinetics: Peak Concentration (Cmax)	406.03	—
SECONDARY Ivermectin Pharmacokinetics: Time to Cmax (Tmax)	9.09	—
SECONDARY Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC)	5078	—
SECONDARY Ivermectin Pharmacokinetics: Half-life (T1/2)	15.75	—
SECONDARY Stress-induced Alcohol Craving	—	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02046200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.