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Baclofen for Smoking Cessation in a Non-Psychiatric Population

NCT01228994 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-09-12

No results posted yet for this study

Summary

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.

Conditions

  • Nicotine Dependence

Interventions

DRUG

Baclofen 30 mg/day

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

DRUG

placebo pill

placebo pill

DRUG

Baclofen 60 mg/day

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

Sponsors & Collaborators

  • Canadian Tobacco Control Research Initiative

    collaborator OTHER

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Bernard Le Foll, MD, PhD · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01228994 on ClinicalTrials.gov