drugset / Trial / NCT01057862
Investigation of Naltrexone for Pathological Gambling
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The investigators plan to investigate the safety, tolerability, and efficacy of the opioid antagonist naltrexone in Pathological Gambling. We hypothesize that naltrexone will be superior to placebo in reducing gambling urges and behavior, when combined with adjuvant non-pharmacological treatment as usual.
Timeline
- Start
- 2009-02
- Primary completion
- 2016-02
- Completion
- 2017-01
Publications
- Background Dannon PN, Lowengrub K, Gonopolski Y, Musin E, Kotler M. Pathological gambling: a review of phenomenological models and treatment modalities for an underrecognized psychiatric disorder. Prim Care Companion J Clin Psychiatry. 2006;8(6):334-9. doi: 10.4088/pcc.v08n0603.
- Background Grant JE, Kim SW, Hartman BK. A double-blind, placebo-controlled study of the opiate antagonist naltrexone in the treatment of pathological gambling urges. J Clin Psychiatry. 2008 May;69(5):783-9. doi: 10.4088/jcp.v69n0511.
- Background Grant JE, Potenza MN, Hollander E, Cunningham-Williams R, Nurminen T, Smits G, Kallio A. Multicenter investigation of the opioid antagonist nalmefene in the treatment of pathological gambling. Am J Psychiatry. 2006 Feb;163(2):303-12. doi: 10.1176/appi.ajp.163.2.303.
- Background Kim SW, Grant JE. An open naltrexone treatment study in pathological gambling disorder. Int Clin Psychopharmacol. 2001 Sep;16(5):285-9. doi: 10.1097/00004850-200109000-00006.
- Background Kim SW, Grant JE, Adson DE, Shin YC. Double-blind naltrexone and placebo comparison study in the treatment of pathological gambling. Biol Psychiatry. 2001 Jun 1;49(11):914-21. doi: 10.1016/s0006-3223(01)01079-4.
- Background Melville KM, Casey LM, Kavanagh DJ. Psychological treatment dropout among pathological gamblers. Clin Psychol Rev. 2007 Dec;27(8):944-58. doi: 10.1016/j.cpr.2007.02.004. Epub 2007 Mar 2.
- Background Pallesen S, Mitsem M, Kvale G, Johnsen BH, Molde H. Outcome of psychological treatments of pathological gambling: a review and meta-analysis. Addiction. 2005 Oct;100(10):1412-22. doi: 10.1111/j.1360-0443.2005.01204.x.
- Background Pallesen S, Molde H, Arnestad HM, Laberg JC, Skutle A, Iversen E, Stoylen IJ, Kvale G, Holsten F. Outcome of pharmacological treatments of pathological gambling: a review and meta-analysis. J Clin Psychopharmacol. 2007 Aug;27(4):357-64. doi: 10.1097/jcp.013e3180dcc304d.
- Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 50 mg | Oral |