Cocaine/Crack and Reduction of Compulsion With Biperiden

September 18, 2020 updated by: Jose Carlos Fernandes Galduroz MD, Federal University of São Paulo

Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden

Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15 and 64 years old. The drug dependence has been described by many authors as a dysfunction of the brain reward system. Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be study. This is a double-blind controlled and randomized placebo study. All the patients will be treated with brief intervention therapy (BIT), and half of them will receive biperiden (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated through the comparison between the values obtained on the following measures before and after the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite (benzoylecgonine) on urine.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • 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

  • Brazil
      • São Paulo, Brazil, 04024-003
        • UDED - Drug Dependence Unit

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)

Exclusion Criteria:

  • Being under treatment with psychoactive drugs
  • Have been diagnosed for other Psychiatric Disorders
  • Have dependence diagnosis for other drugs, except for tabacco

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: Biperiden
Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
Drug: Biperiden
Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
Other Names:
  • Group psychotherapy
Placebo Comparator: Placebo
Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
Drug: Placebo
Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
Other Names:
  • Group psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compulsion
Time Frame: 3 months

The patients answered the Minnesota Cocaine Craving Scale (Halikas et al., 1991).

INTENSITY: Evaluation of crack strength by cocaine in the previous week:

Zero (no craving)---------------------------- -----10 (Intense craving)

Ranges from 0 to 10 (zero = no craving; 10 intense craving). Using a rule starting from 0, we determine the number that corresponds to the compulsion. The farther from 0 the more intense the compulsion will be.

Frequency of craving onset: How many times a day 0 time/day - check: 0 point

  1. time/day - check: 1 point
  2. times/day - check: 2 points
  3. to 5 times/day - check: 3 points

6 to 10 times/day - check: 4 points 11 to 20 times/day - check: 5 points more than 20 times/day - check: 6 points

Ranges from 0 to 6 points (zero = no craving; 1-2 points: Light; 3-4 points: moderate; 5- 6: intense craving).

The sum of the points of the subscales provides the final score.
3 months

Collaborators and Investigators

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

Sponsor

Federal University of São Paulo

Collaborators

Nacional Conseling of Scientific Development and Technology

Investigators

  • Principal Investigator: José C F. Galduróz, Universidade Federal de São Paulo

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

May 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 30, 2010

First Submitted That Met QC Criteria

November 30, 2010

First Posted (Estimate)

December 1, 2010

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACJC2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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