drugset / Trial / NCT00570388
Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive impairment and this in turn will lead to improved ability to resist alcohol related cues and enhance involvement in psychosocial treatment.
Timeline
- Start
- 2007-03
- Primary completion
- —
- Completion
- 2008-09
Publications
- Background Matching alcoholism treatments to client heterogeneity: treatment main effects and matching effects on drinking during treatment. Project MATCH Research Group. J Stud Alcohol. 1998 Nov;59(6):631-9. doi: 10.15288/jsa.1998.59.631.
- Background Barker MJ, Greenwood KM, Jackson M, Crowe SF. Cognitive effects of long-term benzodiazepine use: a meta-analysis. CNS Drugs. 2004;18(1):37-48. doi: 10.2165/00023210-200418010-00004.
- Background Bates ME, Pawlak AP, Tonigan JS, Buckman JF. Cognitive impairment influences drinking outcome by altering therapeutic mechanisms of change. Psychol Addict Behav. 2006 Sep;20(3):241-53. doi: 10.1037/0893-164X.20.3.241.
- Background Girdler NM, Lyne JP, Wallace R, Neave N, Scholey A, Wesnes KA, Herman C. A randomised, controlled trial of cognitive and psychomotor recovery from midazolam sedation following reversal with oral flumazenil. Anaesthesia. 2002 Sep;57(9):868-76. doi: 10.1046/j.1365-2044.2002.02785.x.
- Background Mason BJ. Treatment of alcohol-dependent outpatients with acamprosate: a clinical review. J Clin Psychiatry. 2001;62 Suppl 20:42-8.
- Background Mason BJ, Goodman AM, Chabac S, Lehert P. Effect of oral acamprosate on abstinence in patients with alcohol dependence in a double-blind, placebo-controlled trial: the role of patient motivation. J Psychiatr Res. 2006 Aug;40(5):383-93. doi: 10.1016/j.jpsychires.2006.02.002. Epub 2006 Mar 20.
- Background Rupp CI, Fleischhacker WW, Drexler A, Hausmann A, Hinterhuber H, Kurz M. Executive function and memory in relation to olfactory deficits in alcohol-dependent patients. Alcohol Clin Exp Res. 2006 Aug;30(8):1355-62. doi: 10.1111/j.1530-0277.2006.00162.x.
- Background Singh N, Sharma A, Singh M. Possible mechanism of alprazolam-induced amnesia in mice. Pharmacology. 1998 Jan;56(1):46-50. doi: 10.1159/000028181.
- Background Srisurapanont M, Jarusuraisin N. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD001867. doi: 10.1002/14651858.CD001867.pub2.
- Background Stewart SA. The effects of benzodiazepines on cognition. J Clin Psychiatry. 2005;66 Suppl 2:9-13.
- Background Tapert SF, Ozyurt SS, Myers MG, Brown SA. Neurocognitive ability in adults coping with alcohol and drug relapse temptations. Am J Drug Alcohol Abuse. 2004 May;30(2):445-60. doi: 10.1081/ada-120037387.
- Background Uekermann J, Daum I, Schlebusch P, Wiebel B, Trenckmann U. Depression and cognitive functioning in alcoholism. Addiction. 2003 Nov;98(11):1521-9. doi: 10.1046/j.1360-0443.2003.00526.x.
- Background Zinn S, Stein R, Swartzwelder HS. Executive functioning early in abstinence from alcohol. Alcohol Clin Exp Res. 2004 Sep;28(9):1338-46. doi: 10.1097/01.alc.0000139814.81811.62.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Flumazenil | Small molecule | 2 mg | Intravenous |
| Comparator | Gabapentin | Small molecule | 1200 mg | Oral |
| Comparator | Hydroxyzine | Small molecule | 50 mg | Oral |
| Comparator | N-acetylcysteine | Small molecule | — | Oral |