NCT00495092

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cocaine Related Disorders

Interventions

Type	Name	Description
DRUG	Caffeine	Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d
DRUG	Biperiden	Biperiden 2-4 mg/d p.o.
DRUG	Placebo	Placebo + Placebo

Timeline

• Start date: 2005-01-01
• Primary completion: 2009-12-01
• Completion: 2010-10-01
• First posted: 2007-07-02
• Last updated: 2012-03-01

Locations

1 site across 1 country: Spain