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Baclofen for Smoking Cessation in a Non-Psychiatric Population

NCT ID: NCT01228994

Last Updated: 2013-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-08-31

Brief Summary

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The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures.

The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i.e. take the medication as directed for the trial period) than those in the placebo group.

The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.

Detailed Description

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This study will test a new medication strategy designed to help smokers quit. It will evaluate Baclofen, a drug currently approved and available in Canada as a myorelaxant. Forty five nicotine-dependent smokers will enroll in this study. Fifteen will receive placebo (inactive pill), fifteen will receive baclofen 30 mg/day, and fifteen will receive baclofen 60 mg/day. Once enrolled, subjects will visit CAMH on a weekly basis for assessment of smoking behaviour, a brief health check (vitals, BP and AE screening), delivery of brief individual smoking cessation counselling, and collection of breath, blood and urine samples (as scheduled) to a) measure levels of nicotine and its metabolites, b) conduct pregnancy and tox testing. The medication phase of this study lasts 12 weeks. Two follow-up visits will be scheduled at week 13 and at six months after trial completion.

Conditions

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Nicotine Dependence

Keywords

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smoking cessation treatment baclofen Smoking cessation counselling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Baclofen 30 mg/day

Baclofen medication

Group Type ACTIVE_COMPARATOR

Baclofen 30 mg/day

Intervention Type DRUG

Baclofen 30 mg/day for 8 weeks with 2 week induction and 2 week decrease

Placebo pill

placebo pill

Group Type PLACEBO_COMPARATOR

placebo pill

Intervention Type DRUG

placebo pill

Baclofen 60 mg/day

Baclofen medication high dose

Group Type ACTIVE_COMPARATOR

Baclofen 60 mg/day

Intervention Type DRUG

baclofen 60 mg/day for 8 weeks with 2 week induction and 2 week decrease

Interventions

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Baclofen 30 mg/day

Baclofen 30 mg/day for 8 weeks with 2 week induction and 2 week decrease

Intervention Type DRUG

placebo pill

placebo pill

Intervention Type DRUG

Baclofen 60 mg/day

baclofen 60 mg/day for 8 weeks with 2 week induction and 2 week decrease

Intervention Type DRUG

Other Intervention Names

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Lioresal, Kemstro Lioresal, Kemstro

Eligibility Criteria

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Inclusion Criteria

* Male or female adults (18 years or older).
* Meet DSM-IV criteria for nicotine dependence,
* Smoke ≥10 cigarettes/day,
* Baseline FTND score ≥4, CO level ≥10,
* have had at least one failed quit attempt in the past and are motivated to quit within 30 days of initial intake.
* No previous use of medication for smoking cessation in 1 month prior to randomization.
* BMI between 15 and 40 inclusive.

Exclusion Criteria

* Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder, or a current or past history of bipolar disorder or schizophrenia
* Have a past history of major depression, with historical evidence of suicidal or homicidal behaviour, or psychotic symptom,
* Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 3 months prior to randomization
* Demonstrate serious medical conditions, unstable cardiovascular disease, significant blood abnormalities)
* Are pregnant, are trying to become pregnant or are currently breastfeeding
* Baclofen hypersensitivity .
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Tobacco Control Research Initiative

OTHER

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Bernard Le Foll

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernard Le Foll, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health- 33 Russell St

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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http://www.camh.net/research

Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre

Other Identifiers

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1632009

Identifier Type: -

Identifier Source: org_study_id