Clinical Trial: Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients

Brief Summary:

The aim of this study is to assess the efficacy of caffeine compared to placebo in detoxifying cocaine dependent patients. Caffeine potentiation with biperiden will be also studied.

108 with cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) or caffeine (300 - 1200 mg t.i.d.) with placebo or placebo during 6 months.

Primary efficacy outcomes will be 1) patient comfort assessed with abstinence symptomatology, craving for cocaine and mental status during detoxifying period, 2) study retention and 3) cocaine use.

Brain dopamine system will be assessed thru IBZM-SPECT and the apomorphine test.

Detailed Summary:
Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Current Primary Outcome: 1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use. [ Time Frame: 12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hospital Universitari Vall d'Hebron Research Institute

Dates:
Date Received: June 29, 2007
Date Started: January 2005
Date Completion:
Last Updated: February 29, 2012
Last Verified: February 2012