Baclofen Effects on Smoking Urge and Withdrawal
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.
Nicotine Use Disorder
Tobacco Use Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Baclofen Effects on Smoking Urge and Withdrawal|
- Two measures are equally important: 1) Total score on Questionnaire of Smoking Urges; 2) Minnesota Nicotine Withdrawal Scale [ Time Frame: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation. ] [ Designated as safety issue: No ]Questionnaire of Smoking Urges assesses cravings to smoke. Minesota Nicotine Withdrawal Questionnaire assesses nicotine withdrawal
- Nicotine self-administration as quantified by salivary cotinine boost during a behavioral self-administration task. [ Time Frame: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation. ] [ Designated as safety issue: No ]
- Cigarette choice task [ Time Frame: Tenth day of medication titration ] [ Designated as safety issue: No ]Number of choices for cigarette puffs vs. financial incentive in a behavioral economics procedure.
|Study Start Date:||December 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: Arm 1
Healthy people from the surrounding community who smoke at least 10 cigarettes per day and not ready to quit smoking
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257894
|United States, Rhode Island|
|VA Medical Center, Providence|
|Providence, Rhode Island, United States, 02908|
|Principal Investigator:||Damaris Rohsenow, PhD||VA Medical Center, Providence|