Nicotine Dependence
Conditions
Brief summary
The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.
Interventions
DRUGSelegiline Transdermal Patch
Selegiline cm(2) via transdermal system
DRUGPlacebo
Matching placebo via transdermal system
BEHAVIORALSmoking Cessation Counseling
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Sponsors
VA Office of Research and Development
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be at least 18 years of age * Be in good general health * Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for nicotine dependence * Be currently smoking \> 15 cigarettes/day, and have smoked cigarettes for the past 5 years * Subjects must be motivated to quite smoking * If female and of child bearing potential, agrees to use birth control and subject * Subject must be able to understand and provide written informed consent. Exclusion Criteria: * Please contact site for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quit Rate | Study weeks 6 through 9 | The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence | week 14 | The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Selegiline Transdermal System Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks | 121 |
| Placebo Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks | 125 |
| Total | 246 |
Baseline characteristics
| Characteristic | Placebo | Total | Selegiline Transdermal System |
|---|---|---|---|
| Age, Continuous | 47.3 years STANDARD_DEVIATION 13.6 | 46.5 years STANDARD_DEVIATION 14 | 45.6 years STANDARD_DEVIATION 14.2 |
| Gender Female | 59 Participants | 121 Participants | 62 Participants |
| Gender Male | 66 Participants | 125 Participants | 59 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 59 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 87 Participants | 173 Participants | 86 Participants |
| Region of Enrollment United States | 125 participants | 246 participants | 121 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 99 / 121 | 76 / 125 |
| serious Total, serious adverse events | 3 / 121 | 0 / 125 |
Outcome results
Primary
Quit Rate
The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).
Time frame: Study weeks 6 through 9
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selegiline Transdermal System | Quit Rate | 18 participants |
| Matching Placebo | Quit Rate | 15 participants |
Secondary
Abstinence
The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group.
Time frame: week 14
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selegiline Transdermal System | Abstinence | 16 participants |
| Matching Placebo | Abstinence | 10 participants |