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Enhancing a High School Based Smoking Cessation Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01145001
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : October 19, 2016
Last Update Posted : December 29, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking

Arms and Interventions
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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145001


Locations
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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
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Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01145001    
Other Study ID Numbers: 020718574
P50DA009241-17 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2010    Key Record Dates
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:
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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