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

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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.


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Charlottesville, VA
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Richmond, Virginia 23294
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Richmond, VA
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