drugset / Trial / NCT00811720
Efficacy of Nalmefene in Patients With Alcohol Dependence
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
Timeline
- Start
- 2008-12
- Primary completion
- 2010-10
- Completion
- 2010-11
Outcome
Met primary endpoint
registry Placebo vs Nalmefene 18.06 mg; p = 0.002; Mean Difference (Final Values) -2.33 (95% CI -3.81 to -0.85) NCT00811720 ↗
registry Placebo vs Nalmefene 18.06 mg; p <0.001; Mean Difference (Final Values) -10.96 (95% CI -16.81 to -5.11) NCT00811720 ↗
Publications
- Results Mann K, Bladstrom A, Torup L, Gual A, van den Brink W. Extending the treatment options in alcohol dependence: a randomized controlled study of as-needed nalmefene. Biol Psychiatry. 2013 Apr 15;73(8):706-13. doi: 10.1016/j.biopsych.2012.10.020. Epub 2012 Dec 11.
- Aubin HJ, Reimer J, Nutt DJ, Bladstrom A, Torup L, Francois C, Chick J. Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients. Eur Addict Res. 2015;21(3):160-168. doi: 10.1159/000371547. Epub 2015 Mar 31.
- Laramee P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, Francois C, Toumi M, Daeppen JB, Rehm J. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014 Sep 16;4(9):e005376. doi: 10.1136/bmjopen-2014-005376.
- van den Brink W, Aubin HJ, Bladstrom A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 Sep-Oct;48(5):570-8. doi: 10.1093/alcalc/agt061. Epub 2013 Jul 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nalmefene | Small molecule | 18.06 mg | Oral |