Smoking Lapse Behavior
Conditions
Keywords
smoking lapse behavior, smoking cessation, varenicline, bupropion, medication effect on smoking lapse behavior
Brief summary
The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.
Interventions
DRUGvarenicline
2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).
DRUGbupropion
300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).
DRUGPlacebo
Placebo
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* ages 18-55 * able to read and write in English * Smokers
Exclusion criteria
* any significant current medical or psychiatric conditions that would contraindicate smoking * current Diagnostic and Statistical Manual IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse * positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines * women who are pregnant or nursing * suicidal, homicidal, or evidence of current severe mental illness * participants prescribed any psychotropic drug in the 30 days prior to study enrollment * blood donation within the past 6 weeks * individuals seeking treatment for smoking cessation or have attempted to quit smoking within the past 3 months * specific exclusions for bupropion administration not already specified, including: have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology * known allergy to varenicline or taking H2blockers * participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Latency to Initiate Ad-lib Smoking Session | 0 to 50 minutes | minutes to start smoking (range 0 to 50 minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cigarettes Smoked During the 60 Minute Ad-lib Period | 60 minutes | number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline varenicline 2mg/day
varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8). | 20 |
| Bupropion Bupropion 300mg/day
bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8). | 21 |
| Placebo Placebo Control
Placebo: Placebo | 21 |
| Total | 62 |
Baseline characteristics
| Characteristic | Varenicline | Bupropion | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 34.95 years STANDARD_DEVIATION 11.36 | 34.95 years STANDARD_DEVIATION 9.7 | 36.47 years STANDARD_DEVIATION 10.95 | 35.47 years STANDARD_DEVIATION 6.95 |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 9 Participants | 26 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 12 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 13 / 20 | 13 / 21 | 13 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 | 0 / 21 |
Outcome results
Primary
Latency to Initiate Ad-lib Smoking Session
minutes to start smoking (range 0 to 50 minutes)
Time frame: 0 to 50 minutes
Population: Subsample with high nicotine dependence
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Latency to Initiate Ad-lib Smoking Session | 38.138 minutes | Standard Error 6.268 |
| Bupropion | Latency to Initiate Ad-lib Smoking Session | 39.416 minutes | Standard Error 5.939 |
| Placebo | Latency to Initiate Ad-lib Smoking Session | 19.249 minutes | Standard Error 6.196 |
Secondary
Number of Cigarettes Smoked During the 60 Minute Ad-lib Period
number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Number of Cigarettes Smoked During the 60 Minute Ad-lib Period | .713 number of cigarettes | Standard Error 0.351 |
| Bupropion | Number of Cigarettes Smoked During the 60 Minute Ad-lib Period | 1.287 number of cigarettes | Standard Error 0.342 |
| Placebo | Number of Cigarettes Smoked During the 60 Minute Ad-lib Period | 2.085 number of cigarettes | Standard Error 0.396 |