Cocaine/Crack and Reduction of Compulsion With Biperiden

NCT01251393 | Completed Phase 3 Results DMC

• 1 other identifier: ACJC2010
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine Dependence

Keywords

Cocaine; crack; treatment; dependence; biperiden

Outcome Measures

Primary Outcomes (1)

• Compulsion

  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

Study Arms (2)

Biperiden

EXPERIMENTAL

Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.

Drug: Biperiden

Placebo

PLACEBO COMPARATOR

Thirty volunteers will take three pills of Placebo (6mg/day) during two months.

Drug: Placebo

Interventions

Biperiden DRUG

Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.

Also known as: Group psychotherapy

Biperiden

Placebo DRUG

Thirty volunteers will take three pills of Placebo (6mg/day) during two months.

Also known as: Group psychotherapy

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Nacional Conseling of Scientific Development and Technology: collaborator

Study Sites (1)

UDED - Drug Dependence Unit

São Paulo, 04024-003, Brazil

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Biperiden; Psychotherapy, Group

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Bridged Bicyclo Compounds; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azabicyclo Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: PhD José Carlos F. Galduróz
• Organization: Universidade Federal de São Paulo

galduroz@unifesp.br

Study Officials

• José C F. Galduróz

  Universidade Federal de São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: November 1, 2012
• Last Updated: October 14, 2020
• Results First Posted: February 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)