Tobacco Use Disorder
Conditions
Brief summary
Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of this study is examine whether selegiline, given in the form of a skin patch, is effective in stopping smoking.
Detailed description
Most smokers relapse following smoking cessation treatment. More effective smoking cessation therapies are needed to prevent the high rates of relapse. Selegiline is a selective inhibitor of monoamine oxidase B (MAO B) and has been used clinically in combination with levodopa to treat Parkinson's disease. Selegiline permits the stabilization of dopamine (DA) levels in the brain by preventing the rapid degradation of DA by means of MAO B and is used as an adjunct to levodopa therapy causing a dose-sparing effect and enhancing dopaminergic transmission. Selegiline's effect on MAO B and the resulting effect on brain DA has interesting implications for the treatment of nicotine dependence because brain DA systems may play a key role in the mediation of reward learning behavior. Previous research suggests that the brains of living smokers show a 40% decrease in the level of MAO B relative to nonsmokers or former smokers. The purpose of this study is examine whether selegiline, administered in the form of a skin patch, is effective for smoking cessation. Participants will be randomly assigned to one of two treatments: 1) transdermal selegiline patch (STS) or 2) placebo. Treatment with STS or placebo will be given for a period of 8 weeks. Participants will be stratified by gender to evaluate the role that gender plays in moderating smoking cessation treatment. Study visits will take place once each week for 30 to 45 minutes, and will include adverse events monitoring, biochemical verification of smoking status, and a physical exam. Follow-up visits will occur at Weeks 24 and 52 to determine response to treatment.
Interventions
DRUGSelegiline
6mg/24 hrs for 8 weeks
OTHERmatching placebo
placebo/24hrs for 8 weeks
Sponsors
National Institute on Drug Abuse (NIDA)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Smokes greater than 20 cigarettes per day
Exclusion criteria
* History of Parkinson's disease, high blood pressure, or severe liver or kidney disease * Current substance abuse * Mental illness * Skin conditions that could interfere with patch use * Using antidepressant medications (e.g., levodopa/carbidopa, methyldopa, or any MAO inhibitor) * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expired-air Carbon Monoxide Confirmed Smoking Abstinence | 52 weeks | expired-air carbon monoxide confirmed smoking abstinence at 52 weeks |
Countries
United States
Participant flow
Pre-assignment details
The original target enrollment was 230. Over recruitment led to a study sample size =243
Participants by arm
| Arm | Count |
|---|---|
| Drug Selegiline 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks
Selegiline: 6mg/24 hrs for 8 weeks | 121 |
| Matching Placebo matching placebo worn 24 hours for 8 weeks
matching placebo: placebo/24hrs for 8 weeks | 122 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 17 |
Baseline characteristics
| Characteristic | Drug Selegiline | Matching Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 121 Participants | 122 Participants | 243 Participants |
| Region of Enrollment United States | 121 participants | 122 participants | 243 participants |
| Sex: Female, Male Female | 37 Participants | 37 Participants | 74 Participants |
| Sex: Female, Male Male | 84 Participants | 85 Participants | 169 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 110 / 121 | 108 / 122 |
| serious Total, serious adverse events | 0 / 121 | 0 / 122 |
Outcome results
Primary
Expired-air Carbon Monoxide Confirmed Smoking Abstinence
expired-air carbon monoxide confirmed smoking abstinence at 52 weeks
Time frame: 52 weeks
Population: intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Drug Selegiline | Expired-air Carbon Monoxide Confirmed Smoking Abstinence | 24 participants not smoking |
| Matching Placebo | Expired-air Carbon Monoxide Confirmed Smoking Abstinence | 25 participants not smoking |