Phase 3
N=111
Cocaine/Crack and Reduction of Compulsion With Biperiden
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01251393 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Compulsion — 5.9; 5.5 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Biperiden (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Federal University of São Paulo
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compulsion |
5.9; 5.5 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01251393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.