Enhancing a High School Based Smoking Cessation Program

Not Applicable

Completed

• Conditions: Nicotine Dependence
• Interventions: Behavioral: Cognitive Behavioural Therapy; Behavioral: Contingency Management; Drug: Nicotine Transdermal Patch

• Registration Number: NCT01145001
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-16
• Primary Completion: 2014-07
• Study Completion: 2015-01
• Results First Submitted: 2016-08-24
• Results First Submitted QC: 2016-08-24
• Results First Posted: 2016-10-19
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• High School aged
• Desire to quit smoking
• Smoking >5 cigarettes per day
• Able to read and write in English

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Exclusion Criteria

• Current dependence on other substances
• Medical conditions that would contraindicate the use of a nicotine patch

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Patch with no Contingency Management	Cognitive Behavioural Therapy	Subjects in this group will receive active nicotine patch without contingency management for abstinence
Placebo patch and Contingency Management	Cognitive Behavioural Therapy	Subjects in this group will receive a placebo transdermal patch and contingency management
Placebo patch and Contingency Management	Contingency Management	Subjects in this group will receive a placebo transdermal patch and contingency management
Placebo Patch and no Contingency Management	Cognitive Behavioural Therapy	Subjects in this group will receive a placebo patch and will not receive contingency management
Active Nicotine Patch and Contingency Management	Cognitive Behavioural Therapy	Subjects in this group will receive Contingency Management and active nicotine patch
Active Nicotine Patch and Contingency Management	Contingency Management	Subjects in this group will receive Contingency Management and active nicotine patch
Nicotine Patch with no Contingency Management	Nicotine Transdermal Patch	Subjects in this group will receive active nicotine patch without contingency management for abstinence
Active Nicotine Patch and Contingency Management	Nicotine Transdermal Patch	Subjects in this group will receive Contingency Management and active nicotine patch

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Continuous Abstinence During Treatment	6 weeks	We will also examine continuous abstinence during the six week treatment period by urine analysis each week.

Trial Locations

Locations (1)

CMHC; 🇺🇸 New Haven, Connecticut, United States