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Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence

NCT00495183 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2010-05-27

No results posted yet for this study

Summary

The aim of this study is to assess the efficacy of caffeine compared to placebo as a maintenance treatment for cocaine dependence. Caffeine potentiation with biperiden will be also studied.

Ninety patients with snorted/sniffed cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) caffeine (300 - 1200 mg t.i.d.) with placebo or placebo during 10 days in an in-hospital setting.

Conditions

  • Cocaine Dependence

Interventions

DRUG

caffeine

caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.

DRUG

Biperiden

Biperiden 2-4 mg/d, divided in 2 doses per day.

DRUG

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
2009-01-31
Primary Completion
2010-07-31
Completion
2010-07-31

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 NCT00495183 on ClinicalTrials.gov