Cocaine/Crack and Reduction of Compulsion With Biperiden
Primary Purpose
Cocaine Dependence
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Biperiden
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine, crack, treatment, dependence, biperiden
Eligibility Criteria
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
Sites / Locations
- UDED - Drug Dependence Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Biperiden
Placebo
Arm Description
Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
Outcomes
Primary Outcome Measures
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
time/day - check: 1 point
times/day - check: 2 points
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01251393
First Posted
November 30, 2010
Last Updated
September 18, 2020
Sponsor
Federal University of São Paulo
Collaborators
Nacional Conseling of Scientific Development and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01251393
Brief Title
Cocaine/Crack and Reduction of Compulsion With Biperiden
Official Title
Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Nacional Conseling of Scientific Development and Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Cocaine, crack, treatment, dependence, biperiden
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biperiden
Arm Type
Experimental
Arm Description
Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
Intervention Type
Drug
Intervention Name(s)
Biperiden
Other Intervention Name(s)
Group psychotherapy
Intervention Description
Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Group psychotherapy
Intervention Description
Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
Primary Outcome Measure Information:
Title
Compulsion
Description
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
time/day - check: 1 point
times/day - check: 2 points
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.
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José C F. Galduróz
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
UDED - Drug Dependence Unit
City
São Paulo
ZIP/Postal Code
04024-003
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cocaine/Crack and Reduction of Compulsion With Biperiden
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