Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT01228994
Status:
TERMINATED
Last Update Posted:
2013-09-12
First Post:
2010-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Baclofen for Smoking Cessation in a Non-Psychiatric Population
Sponsor:
Centre for Addiction and Mental Health
Organization:
Study Overview
Official Title:
Testing the GABAergic Hypothesis of Nicotine Dependence: a Randomized Clinical Trial of Baclofen
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated because of difficulties recruiting subjects.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Baclofen
Brief 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.
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:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: