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

NCT00495092 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2012-03-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Miquel Casas, Prof. · Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-12-31
Completion
2010-10-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00495092 on ClinicalTrials.gov