Los Angeles, California 90095

  • Alcohol Use Disorder

Purpose:

This study is a double-blind, placebo-controlled randomized clinical trial of IBUD (50mg BID) for the treatment of Alcohol Use Disorder (AUD). Eligible participants will undergo a 12-week medication treatment period and 5 in-person visits over 16 weeks.


Study summary:

The study design consists of a 12-week, double-blind, placebo-controlled randomized clinical trial of IBUD (50mg BID) for the treatment of Alcohol Use Disorder (AUD). The investigators will randomize 132 treatment-seekers with current AUD over the course of 4 years. As a behavioral support platform, all participants will complete the NIAAA-developed and computer-delivered program "Take Control" during the study. Participants will complete telephone screening, followed by in-person eligibility assessment, a physical exam for medical eligibility, randomization to study medication or matched placebo, and in-person follow-up visits at 4, 8, and 12 weeks of treatment. TLFB assessment of drinking outcomes will also occur by telephone on weeks 2, 6, and 10. A final safety check visit will occur on week 16, consisting of repeated clinical labs and ECG.


Criteria:

Inclusion Criteria: 1. Be between the ages of 18 and 65 2. Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for alcohol use disorder moderate or severe 3. Be treatment-seeking for AUD 4. Report drinking at least 28 drinks per week if male (21 drinks per week if female) in the 28 days prior to consent Exclusion Criteria: 1. Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine 2. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder 3. Have a positive urine screen for narcotics, amphetamines, or sedative hypnotics; 4. Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R) 5. Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile: - Oral contraceptives - Contraceptive sponge - Patch - Double barrier - Intrauterine contraceptive device - Etonogestrel implant - Medroxyprogesterone acetate contraceptive injection - Complete abstinence from sexual intercourse - Hormonal vaginal contraceptive ring 6. Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes) 7. Have AST, ALT, or GGT ≥ 3 times upper normal limit 8. Have attempted suicide in the past 3 years and/or have had serious suicidal intention or plan in the past year 9. Currently be on prescription medication that contraindicates use of IBUD, including alpha or beta agonists, theophylline, or other sympathomimetic 10. Currently be on any medications for AUD or any psychotropic medications (e.g., psychostimulants and benzodiazepines) with the exception of stable antidepressants (stable dose for ≥4 weeks) 11. Have any other circumstances that, in the opinion of the investigators, compromises participant safety.


NCT ID:

NCT03594435


Primary Contact:

Principal Investigator
Lara A. Ray, PhD
University of California, Los Angeles

Jessica Jenkins, MS
Phone: 310-206-6756
Email: jenkinsj@ucla.edu


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States

Jessica Jenkins, MA
Phone: 310-206-6756
Email: raylab@psych.ucla.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 20, 2021

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