Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
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.
|Cocaine Related Disorders||Drug: Caffeine Drug: Biperiden Drug: Placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients|
- 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. ]
|Study Start Date:||January 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
This study arm will receive caffeine+placebo
Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d
this study arm will receive Caffeine+Biperiden
Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/dDrug: Biperiden
Biperiden 2-4 mg/d p.o.
Placebo Comparator: 3
this study arm will receive placebo+placebo
Placebo + Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495092
|Hospital Universitari Vall d'Hebron|
|Barcelona, Catalonia, Spain, 08035|
|Principal Investigator:||Miquel Casas, Prof.||Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain|