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

Cocaine Related Disorders Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Related Disorders
• Cocaine-Related Disorders

• NCT number: NCT00495092
• Study type: Interventional
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2005
• Completion date: October 2010