Study of the effects of biperiden in the treatment of alcoholism

Effects of biperiden in the treatment of alcohol use disorder: a randomized, double-blind, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-2v4qz72

Enrollment

Unknown

Registered

2023-09-18

Start date

2023-09-28

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

Disorders Related to Alcohol Use

Interventions

A randomized, double-blind, placebo-controlled clinical study with people who have a diagnosis of alcohol use disorder classified as severe (APA, 2013). The methods of the present study will follow th

D02.455.426.100.080.100

Eligibility

Sex/Gender

Male

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients with alcohol dependence, according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition; age between 18 and 50 years old; male; literate the ability to write and read in Portuguese

Exclusion criteria

Exclusion criteria: Present other serious psychiatric disorders, such as schizophrenia and bipolar mood disorder; present severe dependence criteria for other drugs, except tobacco; have severe cognitive impairment

Design outcomes

Primary

Measure	Time frame
It is expected to find a decrease in the compulsion for alcohol among participants who used biperiden, when compared to participants in the control group. The evaluations of the level of compulsion before and after treatment will be made by applying two scales: the Obsessive-Compulsive Drinking Scale, is a self-report scale that includes questions that assess the compulsion to stop drinking and the obsessive-compulsive components; Penn Alcohol Craving Scale, is a self-report scale that assesses compulsion for alcoholic beverages	—

Measure

Time frame

It is expected to find a decrease in the compulsion for alcohol among participants who used biperiden, when compared to participants in the control group. The evaluations of the level of compulsion before and after treatment will be made by applying two scales: the Obsessive-Compulsive Drinking Scale, is a self-report scale that includes questions that assess the compulsion to stop drinking and the obsessive-compulsive components; Penn Alcohol Craving Scale, is a self-report scale that assesses compulsion for alcoholic beverages

—

Secondary

Measure	Time frame
No secondary outcomes expected	—

Countries

Brazil

Contacts

Public ContactJosé Carlos Galduróz

Escola Paulista de Medicina - Universidade Federal de São Paulo

galduroz@unifesp.br+55 (11) 21490168

Outcome results

None listed

Source: REBEC (via WHO ICTRP)