NCT00769158

Combining Medications for the Treatment of Alcohol Dependence: An Inpatient Preliminary Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Bankole Johnson · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

We propose to conduct an inpatient pilot study to test the safety and potential efficacy of topiramate and naltrexone in combination for the treatment of alcoholism.

Detailed description

Eight (n = 8) alcohol-dependent research volunteers, not seeking treatment, will complete a placebo-controlled, within-subject cross-over design in which alcohol-related and control cues are presented as stimuli to induce alcohol-seeking behavior under controlled laboratory conditions after repeated dose (chronic) treatment with double-blind doses of placebo or topiramate + naltrexone.Subjects will reside in an inpatient environment for two separate 9-day blocks interspersed by a 1-week washout period. During separate blocks, topiramate + naltrexone and placebo doses will be administered orally on a twice-daily regimen (08:00 h and 20:00 h) for 8 days.Doses will start the evening of day 1 and the last dose will be given the morning of day 8. No doses will be given the evening of day 8 or the morning of day 9. On Days 7 and 8 of the dosing regimen, subjects will receive alcohol and alcohol-related cues or the corresponding control cues.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Topiramate and Naltrexone	Topiramate 200 mg and Naltrexone 50 mg
OTHER	Placebo	Placebo Comparator

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-10-01
• Completion: 2010-12-01
• First posted: 2008-10-08
• Last updated: 2012-02-07

Locations

2 sites across 1 country: United States