Possibia

769158

Last Update Posted: 2012-02-07

Recruiting has ended

All Genders

accepted

21 Years-45 Years

4 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

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

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.

Eligibility

Relevant conditions:

Alcoholism

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

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Data sourced from ClinicalTrials.gov