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Study of the effects of Biperiden drug on reducing the desire to quit smoking

Study of the acute effects of Biperiden on nicotine cravings: double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-7qtvbh3
Enrollment
Unknown
Registered
2025-04-17
Start date
2023-10-20
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

Tobacco Use Disorder

Interventions

This is a two-arm, double-blind, randomized controlled clinical study. A total of 40 people who meet the eligibility criteria will be probabilistically allocated to one or another intervention group u
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Sponsors

Escola Paulista de Medicina
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients with nicotine use disorder, according to DSM-5 criteria; who have intense compulsion, according to the Questionnaire of Smoking Urges-Brief (43 or more points); aged between 18 and 60 years; male and literate (with the ability to write and read Portuguese)

Exclusion criteria

Exclusion criteria: Present other psychiatric disorders (serious such as schizophrenia and bipolar mood disorder); severe disorder criteria when using other drugs or severe cognitive impairment

Design outcomes

Primary

MeasureTime frame
It is expected to observe a decrease in the compulsion to use nicotine and the number of cigarettes used per day, as well as changes in anxiety, depression and degree of dependence.

Secondary

MeasureTime frame
No secondary internships are expected.

Countries

Brazil

Contacts

Public ContactJosé Galduróz

Universidade Federal de São Paulo

galduroz@unifesp.br+55(11) 2149 0155

Outcome results

None listed

Source: REBEC (via WHO ICTRP)