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

May 26, 2010 updated by: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xavier Castells, MD
  • Phone Number: 0034 93 489 42 94
  • Email: xcc@icf.uab.cat

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Carlos Roncero, MD
        • Sub-Investigator:
          • Castells Xavier, MD
        • Sub-Investigator:
          • Gonzalvo Begoña, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of cocaine dependence, according to DSM-IV-TR criteria
  • age between 18 and 60 years
  • current cocaine use, confirmed by a positive urine drug screen for cocaine the week prior to admission.
  • demonstrated capacity to grant informed consent and sign the pertinent informed consent form.
  • place of residence compatible with attendance at the center.
  • for women, willingness to use effective contraceptive measures during the study.

Exclusion Criteria:

  • diagnosis of a severe medical disorder that could interfere with the study
  • presence of an organic pathology for which methylxanthines or biperidene administration is contraindicated
  • serum liver transaminase levels 3 times higher than normal values
  • pregnancy and breast-feeding
  • neuroleptic medication treatment in the past 6 weeks
  • current treatment, or anticipation that the patient may need to initiate treatment during the study, with drugs that may interact with study medication.
  • current diagnosis of a major mental disorder.
  • awareness of a situation that could prevent the patient's participation in the study (e.g. serving a sentence)
  • current participation in another research project.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
caffeine + placebo
Drug: caffeine
caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
Other Names:
  • Durvitan
Experimental: 2
caffeine + biperiden
Drug: caffeine
caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
Other Names:
  • Durvitan
Drug: Biperiden
Biperiden 2-4 mg/d, divided in 2 doses per day.
Other Names:
  • Akineton
Placebo Comparator: 3
Placebo+placebo
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival
Time Frame: 22 weeks
22 weeks
cocaine use
Time Frame: 22 weeks
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Miquel Casas, Prof., Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

June 29, 2007

First Submitted That Met QC Criteria

June 29, 2007

First Posted (Estimate)

July 2, 2007

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAF-MT
  • eudraCT 2005-06-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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