Nicotine Dependence
Conditions
Keywords
smoking, adolescents, contingency management, nicotine replacement therapy
Brief summary
The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Subjects will be randomly assigned to receive either a nicotine transdermal patch or a placebo patch as well as being randomly assigned to receive either CM or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that subjects receiving both active nicotine patch and CM will have higher rates of abstinence from tobacco than subjects in the other groups.
Interventions
BEHAVIORALCognitive Behavioural Therapy
Weekly CBT for all subjects
BEHAVIORALContingency Management
incentives given for abstinence based on urine analysis
14mg ir 21mg doses based on weight and #cigs/day
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* High School aged * Desire to quit smoking * Smoking \>5 cigarettes per day * Able to read and write in English
Exclusion criteria
* Current dependence on other substances * Medical conditions that would contraindicate the use of a nicotine patch
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence Rates at the End of Treatment | 6 weeks | Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Abstinence During Treatment | 6 weeks | We will also examine continuous abstinence during the six week treatment period by urine analysis each week. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Nicotine Patch and Contingency Management Subjects in this group will receive Contingency Management and active nicotine patch
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day | 36 |
| Nicotine Patch With no Contingency Management Subjects in this group will receive active nicotine patch without contingency management for abstinence
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day | 37 |
| Placebo Patch and Contingency Management Subjects in this group will receive a placebo transdermal patch and contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis | 44 |
| Placebo Patch and no Contingency Management Subjects in this group will receive a placebo patch and will not receive contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects | 37 |
| Total | 154 |
Baseline characteristics
| Characteristic | Nicotine Patch With no Contingency Management | Placebo Patch and Contingency Management | Active Nicotine Patch and Contingency Management | Placebo Patch and no Contingency Management | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 36 Participants | 42 Participants | 34 Participants | 37 Participants | 149 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 5 Participants |
| Age, Continuous | 16.62 years STANDARD_DEVIATION 1.233 | 16.66 years STANDARD_DEVIATION 1.01 | 16.53 years STANDARD_DEVIATION 1.276 | 16.30 years STANDARD_DEVIATION 1.151 | 16.53 years STANDARD_DEVIATION 1.161 |
| Gender Female | 14 Participants | 17 Participants | 11 Participants | 17 Participants | 59 Participants |
| Gender Male | 23 Participants | 27 Participants | 25 Participants | 20 Participants | 95 Participants |
| Region of Enrollment United States | 37 participants | 44 participants | 36 participants | 37 participants | 154 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 32 / 36 | 33 / 37 | 42 / 44 | 33 / 37 |
| serious Total, serious adverse events | 0 / 36 | 0 / 37 | 0 / 44 | 0 / 37 |
Outcome results
Primary
Abstinence Rates at the End of Treatment
Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Nicotine Patch and Contingency Management | Abstinence Rates at the End of Treatment | 35.1 percentage of participants not smoking |
| Nicotine Patch With no Contingency Management | Abstinence Rates at the End of Treatment | 24.3 percentage of participants not smoking |
| Placebo Patch and Contingency Management | Abstinence Rates at the End of Treatment | 38.6 percentage of participants not smoking |
| Placebo Patch and no Contingency Management | Abstinence Rates at the End of Treatment | 36.1 percentage of participants not smoking |
Secondary
Continuous Abstinence During Treatment
We will also examine continuous abstinence during the six week treatment period by urine analysis each week.
Time frame: 6 weeks
Population: this is the intent to treat group-all starters (not treatment completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Nicotine Patch and Contingency Management | Continuous Abstinence During Treatment | 26.1 consecutive days of abstinence | Standard Deviation 14.1 |
| Nicotine Patch With no Contingency Management | Continuous Abstinence During Treatment | 26.6 consecutive days of abstinence | Standard Deviation 13.7 |
| Placebo Patch and Contingency Management | Continuous Abstinence During Treatment | 29 consecutive days of abstinence | Standard Deviation 14.7 |
| Placebo Patch and no Contingency Management | Continuous Abstinence During Treatment | 30 consecutive days of abstinence | Standard Deviation 13 |