Combining Medications for the Treatment of Alcohol Dependence: An Inpatient Preliminary Study
| Status: | Archived |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2008 |
| End Date: | December 2010 |
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.
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.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials