Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00257894 |
The purpose of this study is to determine whether baclofen is effective in reducing smoking urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers.
Condition | Intervention |
---|---|
Nicotine Dependence Nicotine Use Disorder Smoking Tobacco Use Disorder |
Drug: Baclofen |
Study Type: | Interventional |
Study Design: | Double Blind (Subject, Outcomes Assessor), Efficacy Study, Parallel Assignment, Placebo Control, Randomized, Treatment |
Official Title: | Baclofen Effects on Smoking Urge and Withdrawal |
Estimated Enrollment: | 64 |
Study Start Date: | December 2005 |
Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Healthy people from the surrounding community who smoke at least 10 cigarettes per day and not ready to quit smoking
|
Drug: Baclofen
Dosing taken orally for a total of 12 days: 40mg/day vs. 20mg/day vs. 0mg/day (placebo tabs). The 40mg condition will receive 15mg/day the first 3 days(Days 1,2,3), 30mg/day for 3 days(Days 4,5,6), and 40mg/day for 3 days(Days 7,8,9). The 20mg/day condition will receive 15mg/day the first 3 days(Days 1,2,3) and 20mg/day for the next 6 days(Days4-9). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day 11), and 10mg/day(Day 12). 20mg/day condition will receive 20mg/day(Day10), 10mg/day(Day11), and 5mg/day(Day12).
|
OBJECTIVES: The long-term objective of this research program is to improve treatments for tobacco smokers by investigating the effects of medications on self-reported and psychophysiological responses to smoking cues and on behavioral-economic measures of smoking reinforcement during a period of tobacco deprivation. The specific objectives of the present application are to investigate the dose-response effects of baclofen (a GABA-B agonist), 1) on urge, and withdrawal, and 2) on the reinforcement value of smoking as measured by choices for puffs on cigarettes versus an alternative reinforcer among current smokers after 4 hours of smoking deprivation. RESEARCH PLAN: The study will use a randomized placebo-controlled between-subjects design with 64 smokers to investigate the effects of placebo and two doses (20 or 40 mg/day) of baclofen on urge to smoke and withdrawal and on choices for smoking versus money after 4 hours of deprivation.
METHODS: Participants will be healthy people who smoke at least 10 cigarettes per day and who are motivated for future smoking cessation. On Day 0, a baseline session will occur after 4 hours of smoking deprivation and on Day 10 of medication the same assessments will be repeated after the final medication dose has been stabilized for at least 3 days and after 4 hours of supervised smoking deprivation has occurred. Medication differences in urge and withdrawal and in the reinforcement value of smoking cigarettes will be investigated. Dependent measures of urge and withdrawal will be by self-report. The dependent measure of reinforcement value is the ratio of choices for cigarette puffs versus money during a subsequent 2-1/2 hr period.
The choice procedure will clarify the relative reinforcement value of smoking while controlling for non-specific decreases in general activity level resulting from sedation. Nicotine self-administration during the medication period will be quantified using saliva cotinine, as a secondary effect. CLINICAL RELEVANCE: More effective interventions for tobacco use could result in less suffering and mortality and in considerable savings in health care costs associated with cardiovascular disease, pulmonary disorders, and cancer.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Rhode Island | |
VA Medical Center, Providence | |
Providence, Rhode Island, United States, 02908 |
Principal Investigator: | Damaris Rohsenow, PhD | VA Medical Center, Providence |
Responsible Party: | Department of Veterans Affairs ( Rohsenow, Damaris - Principal Investigator ) |
Study ID Numbers: | NEUA-029-04F |
Study First Received: | November 21, 2005 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00257894 History of Changes |
Health Authority: | United States: Federal Government |
Baclofen Conditioning, Classical Nicotine Smoking |
Nicotine polacrilex Smoking Neurotransmitter Agents Nicotine Mental Disorders GABA Agonists |
Muscle Relaxants, Central Tobacco Use Disorder Baclofen Substance-Related Disorders Disorders of Environmental Origin |
Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Tobacco Use Disorder Baclofen Physiological Effects of Drugs Disorders of Environmental Origin Neuromuscular Agents Pharmacologic Actions Smoking |
Habits Pathologic Processes Mental Disorders GABA Agonists Therapeutic Uses Muscle Relaxants, Central Substance-Related Disorders GABA Agents Peripheral Nervous System Agents Central Nervous System Agents |