Cocaine/Crack and Reduction of Compulsion With Biperiden
This study has been completed.
Sponsor:
Federal University of São Paulo
Collaborators:
Nacional Conseling of Scientific Development and Technology, Brazil
Association for Psychopharmacological Research, Brazil
Information provided by (Responsible Party):
JGalduroz, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01251393
First received: November 30, 2010
Last updated: November 23, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence Crack Cocaine Dependence |
Drug: Biperiden Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden |
Resource links provided by NLM:
MedlinePlus related topics:
Obsessive-Compulsive Disorder
Drug Information available for:
Cocaine hydrochloride
U.S. FDA Resources
Further study details as provided by Federal University of São Paulo:
Primary Outcome Measures:
- Compulsion score [ Time Frame: 24 months ] [ Designated as safety issue: No ]The complusion for cocaine/crack will be measured by Minessota Craving Scale and Cocaine/crack Consumption Scale
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251393
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251393
Locations
| Brazil | |
| UDED - Drug Dependence Unit | |
| São Paulo, Brazil, 04024-003 | |
Sponsors and Collaborators
Federal University of São Paulo
Nacional Conseling of Scientific Development and Technology, Brazil
Association for Psychopharmacological Research, Brazil
Investigators
| Principal Investigator: | José C F. Galduróz | Universidade Federal de São Paulo |
More Information
| Responsible Party: | JGalduroz, Dr., Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01251393 History of Changes |
| Other Study ID Numbers: | ACJC2010 |
| Study First Received: | November 30, 2010 |
| Last Updated: | November 23, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of São Paulo:
|
Cocaine crack treatment dependence biperiden |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Cocaine Biperiden Biperiden lactate Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on September 29, 2016