Enhancing a High School Based Smoking Cessation Program

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Nicotine Dependence	Behavioral: Cognitive Behavioural Therapy; Behavioral: Contingency Management; Drug: Nicotine Transdermal Patch	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	154 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Care Provider)
Primary Purpose:	Treatment
Official Title:	Contingency Management for Smoking Cessation in Adolescent Smokers - Phase IV, Enhancing a High School Based Smoking Cessation Program
Study Start Date :	November 2009
Actual Primary Completion Date :	July 2014
Actual Study Completion Date :	January 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Abstinence Rates at the End of Treatment [ Time Frame: 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 :

1. Continuous Abstinence During Treatment [ Time Frame: 6 weeks ]
   We will also examine continuous abstinence during the six week treatment period by urine analysis each week.

Eligibility Criteria

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Ages Eligible for Study:	14 Years to 19 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Connecticut
CMHC
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

National Institutes of Health (NIH)

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Suchitra Krishnan-Sarin, Ph.D.	Yale University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT01145001 History of Changes
Other Study ID Numbers:	020718574; P50DA009241-17 ( U.S. NIH Grant/Contract )
First Posted:	June 16, 2010
Results First Posted:	October 19, 2016
Last Update Posted:	December 29, 2016
Last Verified:	November 2016

Keywords provided by Yale University:

smoking; adolescents; contingency management; nicotine replacement therapy

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Nicotine; Ganglionic Stimulants; Autonomic Agents	Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action