Biperiden effect to reduce the desire to use cocaine/crack

Effects of biperiden (muscarinic antagonist) on cocaine/crack dependence

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-8dzrvjg

Enrollment

Unknown

Registered

2022-01-06

Start date

2018-06-09

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine-related Disorders

Interventions

Intervention Group: 67 participants in this group take, orally, 1 capsule of biperiden every 8 hours, that is, 3 capsules a day, for 3 months. Biperiden capsules contained 2 mg of biperiden. Placebo G

Minnesota Cocaine Craving Scale

Beck Anxiety Scale

Beck Depression Scale

Motivational Stages Scale for Change. This entire assessment procedure took about 1 hour and a half. Participants were evaluated 1, 2 and 3 months after starting the intervention. An attempt was also

F14.2

Eligibility

Sex/Gender

Male

Age

18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Secondary outcomes are not expected.	—

Countries

Brazil

Contacts

Public ContactJosé Galduroz

galduroz@unifesp.br+55 11 21490155

Outcome results

None listed

Source: REBEC (via WHO ICTRP)