drugset / Trial / NCT00498628
Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency
Phase 2
Completed
224 enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
AstraZeneca · collabNational Institute on Drug Abuse (NIDA) · collabUS Department of Veterans Affairs · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.
Timeline
- Start
- 2007-12
- Primary completion
- 2009-08
- Completion
- 2010-03
Outcome
Missed primary endpoint
paper No differences between the quetiapine and placebo groups were detected in the primary outcome, percentage heavy-drinking days, or other drinking outcomes. PMID 21950727 ↗
paper This multisite clinical trial showed no efficacy for quetiapine compared with placebo at reducing alcohol consumption in heavy-drinking alcohol-dependent patients. PMID 21950727 ↗
Publications
- Results Litten RZ, Fertig JB, Falk DE, Ryan ML, Mattson ME, Collins JF, Murtaugh C, Ciraulo D, Green AI, Johnson B, Pettinati H, Swift R, Afshar M, Brunette MF, Tiouririne NA, Kampman K, Stout R; NCIG 001 Study Group. A double-blind, placebo-controlled trial to assess the efficacy of quetiapine fumarate XR in very heavy-drinking alcohol-dependent patients. Alcohol Clin Exp Res. 2012 Mar;36(3):406-16. doi: 10.1111/j.1530-0277.2011.01649.x. Epub 2011 Sep 26.
- Vatsalya V, Kong M, Marsano LM, Kurlawala Z, Chandras KV, Schwandt ML, Ramchandani VA, McClain CJ. Interaction of Heavy Drinking Patterns and Depression Severity Predicts Efficacy of Quetiapine Fumarate XR in Lowering Alcohol Intake in Alcohol Use Disorder Patients. Subst Abuse. 2020 Sep 9;14:1178221820955185. doi: 10.1177/1178221820955185. eCollection 2020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Quetiapine | Small molecule | — | — |