A Phase 2 interventional study of Baclofen and Placebo in Nicotine Use Disorder, Nicotine Dependence and Smoking, sponsored by VA Office of Research and Development. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-11-04.
Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment
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.
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 gamma-aminobutyric acid 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.
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This study's enrollment of 41 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
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Exclusion Criteria:
Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
Drug: Baclofen
Placebo capsules identical to active medication, 3/day for 12 days.
Drug: Placebo
Dosing taken orally for a total of 12 days: 40mg/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). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day 11), and 10mg/day(Day 12).
Also known as: Seroquel
Matched placebo capsules containing inert filler taken orally for a total of 12 days
Total Score on Questionnaire of Smoking Urges
Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge). These data are only available on the subset of participants who participated through Day 10.
Time frame: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.
Minnesota Nicotine Withdrawal Questionnaire
Measure of degree of nicotine withdrawal at the time. Scored as the mean of 8 5-point ratings so the total score ranges from 0 (no withdrawal) to 4 (severe withdrawal). These data are only available on the subset of participants who participated through Day 10.
Time frame: Day 10
Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task.
Expired carbon monoxide (CO) assessed before and after a 2.5-h period when they make choices for cigarette puffs versus money. CO Boost is the difference score, possibly ranging from -25 (improved) to +25 (worse). These data are only available on the subset of participants who participated through Day 10..
Time frame: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.
Cigarette Choice Task
At 20 times spaced over a 2.5 h period, participants chose between smoking two puffs (of pre-determined size) of a cigarette and receiving US$0.10. The primary behavioral outcome measure was number of cigarette choices, ranging from 0 (no smoking) to 20 (smoking the most allowed). These data are only available on the subset of participants who participated through Day 10.
Time frame: Tenth day of medication titration
Participants were veterans recruited from the Veterans Affairs Medical Center, Veterans Affairs Medical Center staff, visitors, and smokers recruited from the community.
| Milestone | Baclofen Condition | Placebo Condition |
|---|---|---|
| Started | 21 | 20 |
| Completed | 17 | 15 |
| Not completed | 4 | 5 |
Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge). These data are only available on the subset of participants who participated through Day 10.
| units on a scale | Baclofen Condition | Placebo Condition |
|---|---|---|
| Total Score on Questionnaire of Smoking Urges | 5.5 ± 2.1 | 5.3 ± 2.3 |
Expired carbon monoxide (CO) assessed before and after a 2.5-h period when they make choices for cigarette puffs versus money. CO Boost is the difference score, possibly ranging from -25 (improved) to +25 (worse). These data are only available on the subset of participants who participated through Day 10..
| units on a scale | Baclofen Condition | Placebo Condition |
|---|---|---|
| Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task. | 4.69 ± 4.16 | 5.27 ± 5.90 |
At 20 times spaced over a 2.5 h period, participants chose between smoking two puffs (of pre-determined size) of a cigarette and receiving US$0.10. The primary behavioral outcome measure was number of cigarette choices, ranging from 0 (no smoking) to 20 (smoking the most allowed). These data are only available on the subset of participants who participated through Day 10.
| choices | Baclofen Condition | Placebo Condition |
|---|---|---|
| Cigarette Choice Task | 15.4 ± 5.7 | 18.2 ± 4.8 |
Measure of degree of nicotine withdrawal at the time. Scored as the mean of 8 5-point ratings so the total score ranges from 0 (no withdrawal) to 4 (severe withdrawal). These data are only available on the subset of participants who participated through Day 10.
| units on a scale | Baclofen Condition | Placebo Condition |
|---|---|---|
| Minnesota Nicotine Withdrawal Questionnaire | 1.06 ± 1.73 | 1.58 ± 2.35 |
Collected over 1 year 11 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Baclofen Condition | — | 0/21 (0%) | 0/21 (0%) |
| Placebo Condition | — | 1/20 (5%) | 0/20 (0%) |
| Event | Baclofen Condition | Placebo Condition |
|---|---|---|
| HospitalizationMusculoskeletal and connective tissue disorders | 0/21 | 1/20 |
| Age, Continuous(years) | Baclofen Condition | Placebo Condition | Total |
|---|---|---|---|
| Mean | 47.4 ± 10.7 | 43.5 ± 9.8 | 45.6 ± 10.3 |
| Sex: Female, Male(Participants) | Baclofen Condition | Placebo Condition | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 11 | 8 | 19 |
| Region of Enrollment(participants) | Baclofen Condition | Placebo Condition | Total |
|---|---|---|---|
| United States | 17 | 15 | 32 |
| Fagerstrom Test for Nicotine Dependence(units on a scale) | Baclofen Condition | Placebo Condition | Total |
|---|---|---|---|
| Mean | 6.18 ± 1.59 | 5.93 ± 2.76 | 6.06 ± 2.18 |
| Number of cigarettes smoked per day(cigarettes) | Baclofen Condition | Placebo Condition | Total |
|---|---|---|---|
| Mean | 20.4 ± 7.6 | 19.0 ± 8.1 | 19.7 ± 7.8 |
| Number of years smoked daily(years) | Baclofen Condition | Placebo Condition | Total |
|---|---|---|---|
| Mean | 28.5 ± 11.9 | 24.9 ± 11.7 | 26.9 ± 11.7 |
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