Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute