Enhancing a High School Based Smoking Cessation Program

Study Overview
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Brief Summary
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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.

Official Title
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Contingency Management for Smoking Cessation in Adolescent Smokers - Phase IV, Enhancing a High School Based Smoking Cessation Program

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy
* Behavioral: Contingency Management
* Drug: Nicotine Transdermal Patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Nicotine Patch and Contingency Management<br>Subjects in this group will receive Contingency Management and active nicotine patch | Behavioral: Cognitive Behavioural Therapy<br>* Weekly CBT for all subjects<br>Behavioral: Contingency Management<br>* incentives given for abstinence based on urine analysis<br>Drug: Nicotine Transdermal Patch<br>* 14mg ir 21mg doses based on weight and #cigs/day<br>* Other names: Habitrol;|
| Active Comparator: Nicotine Patch with no Contingency Management<br>Subjects in this group will receive active nicotine patch without contingency management for abstinence | Behavioral: Cognitive Behavioural Therapy<br>* Weekly CBT for all subjects<br>Drug: Nicotine Transdermal Patch<br>* 14mg ir 21mg doses based on weight and #cigs/day<br>* Other names: Habitrol;|
| Placebo Comparator: Placebo patch and Contingency Management<br>Subjects in this group will receive a placebo transdermal patch and contingency management | Behavioral: Cognitive Behavioural Therapy<br>* Weekly CBT for all subjects<br>Behavioral: Contingency Management<br>* incentives given for abstinence based on urine analysis<br>|
| Placebo Comparator: Placebo Patch and no Contingency Management<br>Subjects in this group will receive a placebo patch and will not receive contingency management | Behavioral: Cognitive Behavioural Therapy<br>* Weekly CBT for all subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Abstinence During Treatment | We will also examine continuous abstinence during the six week treatment period by urine analysis each week. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, adolescents, contingency management, nicotine replacement therapy