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

February 29, 2012 updated by: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Hospital Universitari Vall d'Hebron

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of intranasal 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 centre.
  • 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, iodine or apomorphine 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
This study arm will receive caffeine+placebo
Drug: Caffeine
Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d
Experimental: 2
this study arm will receive Caffeine+Biperiden
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.
Placebo Comparator: 3
this study arm will receive placebo+placebo
Drug: Placebo
Placebo + Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use.
Time Frame: 12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3.
12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3.

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, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

October 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)

March 1, 2012

Last Update Submitted That Met QC Criteria

February 29, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAF-DTX-1
  • INT/71525/2003

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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