Nicotine Dependence
Conditions
Keywords
cigarette smoking, smoking cessation, nicotine dependence
Brief summary
The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.
Detailed description
1. 18-65 years of age, 2. a regular smoker for at least one year, 3. currently smoking 10 or more cigarettes per day, 4. report motivation to quit smoking in the next month.
Interventions
Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.
Sponsors
National Institute on Drug Abuse (NIDA)
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-65 years old * regular smoker for at least one year * currently smoking 10 or more cigarettes per day
Exclusion criteria
* Current Axis I disorder * Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year * Current suicidal risk * Pregnancy or breast feeding * Use of nicotine replacement products or bupropion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biochemically Verified Smoking Abstinence | Six months | 1. Carbon monoxide of expired air 2. Salivary cotinine level of saliva |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Smoking Cessation Counseling * One 60-minute individual session
* Seven 2-hour group sessions
* Two individual brief telephone contacts over an eight-week period.
* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. | 62 |
| Standard Smoking Cessation Counseling * One 60-minute individual session
* Seven 2-hour group sessions
* Two individual brief telephone contacts over an eight-week period.
* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. | 54 |
| Total | 116 |
Baseline characteristics
| Characteristic | Standard Smoking Cessation Counseling | New Smoking Cessation Counseling | 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 | 54 Participants | 62 Participants | 116 Participants |
| Age, Continuous | 47.31 years STANDARD_DEVIATION 10.98 | 44.97 years STANDARD_DEVIATION 11.45 | 46.06 years STANDARD_DEVIATION 11.23 |
| Region of Enrollment United States | 54 participants | 62 participants | 116 participants |
| Sex: Female, Male Female | 22 Participants | 26 Participants | 48 Participants |
| Sex: Female, Male Male | 32 Participants | 36 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 54 |
| other Total, other adverse events | 0 / 62 | 0 / 54 |
| serious Total, serious adverse events | 0 / 62 | 0 / 54 |
Outcome results
Primary
Number of Participants With Biochemically Verified Smoking Abstinence
1. Carbon monoxide of expired air 2. Salivary cotinine level of saliva
Time frame: Six months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Distress Tolerance Cessation Counseling | Number of Participants With Biochemically Verified Smoking Abstinence | 11 Participants |
| Standard Smoking Cessation Counseling | Number of Participants With Biochemically Verified Smoking Abstinence | 12 Participants |