Enhancing a High School Based Smoking Cessation Program - Full Text View

Purpose

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	Intervention
Nicotine Dependence	Behavioral: Cognitive Behavioural Therapy Behavioral: Contingency Management Drug: Nicotine Transdermal Patch


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Contingency Management for Smoking Cessation in Adolescent Smokers - Phase IV, Enhancing a High School Based Smoking Cessation Program

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Abstinence rates at the end of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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:

Abstinence rates during treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
We will also examine continuous abstinence during the six week treatment period by urine analysis each week.


Enrollment:	169
Study Start Date:	November 2009
Study Completion Date:	January 2015
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	14 Years to 19 Years (Child, Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145001

Locations


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

Sponsors and Collaborators

Yale University

National Institutes of Health (NIH)

Investigators


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

More Information


Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT01145001 History of Changes
Other Study ID Numbers:	020718574 P50DA009241-17
Study First Received:	June 14, 2010
Last Updated:	March 30, 2015
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2016