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Enhancing a High School Based Smoking Cessation Program

This study is currently recruiting participants.
Verified June 2012 by Yale University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Suchitra Krishnan-Sarin, Yale University
ClinicalTrials.gov Identifier:
NCT01145001
First received: June 14, 2010
Last updated: July 2, 2012
Last verified: June 2012
History of Changes
  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:

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.


Estimated Enrollment: 240
Study Start Date: November 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145001

Contacts
Contact: Dana Cavallo, Ph.D. 203-974-7607 dana.cavallo@yale.edu
Contact: Thomas Liss, BS 203-974-7555 thomas.liss@yale.edu

Locations
United States, Connecticut
CMHC Recruiting
New Haven, Connecticut, United States, 06519
Contact: Tom Liss, BS     203-974-7555     thomas.liss@yale.edu    
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Suchitra Krishnan-Sarin, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01145001     History of Changes
Other Study ID Numbers: 020718574, P50DA009241-17
Study First Received: June 14, 2010
Last Updated: July 2, 2012
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
Smoking
Substance-Related Disorders
Mental Disorders
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013