Biperiden effect to reduce the desire to use cocaine/crack

Phase 3

• Conditions: Cocaine-related Disorders; C25.775

• Registration Number: RBR-8dzrvjg
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-01-08
• Study Start: 2022-01-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

male; age between 18 and 70 years; severe disorder related to the use of cocaine or crack according to the Diagnostic and Statistical Manual of Mental Disorders criteria, 5th edition (DSM-5 criteria) (published by American Psychiatric Association, 2013)

Exclusion Criteria

other severe psychiatric disorders severe, such as schizophrenia and bipolar mood disorder; severe dependence criteria for other drugs (except tobacco); severe cognitive impairment; Illiteracy; compulsory hospitalization; hearing deficiency; transference to other health service with no partnership with the project; hospitalization discharge due to agressive issues or at the request of the participant; previous use of biperiden

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1: Verify the possible reduction in the number and intensity of relapses, that is, whether or not there were episodes of substance use in patients dependent on crack or cocaine who received biperiden during 3 months of hospitalization, using the Timeline Followback questionnaire , comparing pre-intervention and post-intervention data.;Outcome found 1: the group that received biperiden had a lower amount of substance consumption, compared to the control group, in the evaluation of two months after the start of treatment and six months after the start of treatment, using the Timeline Followback questionnaire, comparing the baseline measurement (pre-intervention) with the measurement after 1, 2 and 3 months of treatment and a 6-month follow-up. The group that received biperiden also had a longer latency of time to make the first consumption in the same evaluations, that is, after 2 and 6 months after the beginning of the treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected.