Naltrexone for Heavy Drinking in Young Adults

Phase 4 Completed 140 enrolled Yale University National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

In this study, 140 heavy drinking young adults (aged 18-25) will be provided with brief counseling and either naltrexone, a medication that is FDA-approved for the treatment of alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for administering low-dose naltrexone, in which daily dosing will be combined with targeted dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted naltrexone will result in greater reductions in frequency of heavy and any drinking compared with daily + targeted placebo.

Timeline

Start: 2008-02
Primary completion: 2012-12
Completion: 2012-12

Outcome

Missed primary endpoint

paper During treatment, percent heavy drinking days (naltrexone: mean = 21.60, SD = 16.05; placebo: mean = 22.90, SD = 13.20) (P = .58) PMID 25742208 ↗

paper percent days abstinent (naltrexone: mean = 56.60, SD = 22.52; placebo: mean = 62.50, SD = 15.75) (P = .39) did not differ by group. PMID 25742208 ↗

Publications

O'Malley SS, Corbin WR, Leeman RF, DeMartini KS, Fucito LM, Ikomi J, Romano DM, Wu R, Toll BA, Sher KJ, Gueorguieva R, Kranzler HR. Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety. J Clin Psychiatry. 2015 Feb;76(2):e207-13. doi: 10.4088/JCP.13m08934.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naltrexone	Small molecule	25 mg	—