Enhancing a High School Based Smoking Cessation Program

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01145001
First received: June 14, 2010
Last updated: June 18, 2014
Last verified: June 2014

June 14, 2010
June 18, 2014
November 2009
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01145001 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Enhancing a High School Based Smoking Cessation Program
Contingency Management for Smoking Cessation in Adolescent Smokers - Phase IV, Enhancing a High School Based Smoking Cessation Program

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Nicotine Dependence
  • 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: Active Nicotine Patch and Contingency Management
    Subjects in this group will receive Contingency Management and active nicotine patch
    Interventions:
    • Behavioral: Cognitive Behavioural Therapy
    • Behavioral: Contingency Management
    • Drug: Nicotine Transdermal Patch
  • Active Comparator: Nicotine Patch with no Contingency Management
    Subjects in this group will receive active nicotine patch without contingency management for abstinence
    Interventions:
    • Behavioral: Cognitive Behavioural Therapy
    • Drug: Nicotine Transdermal Patch
  • Placebo Comparator: Placebo patch and Contingency Management
    Subjects in this group will receive a placebo transdermal patch and contingency management
    Interventions:
    • Behavioral: Cognitive Behavioural Therapy
    • Behavioral: Contingency Management
  • Placebo Comparator: Placebo Patch and no Contingency Management
    Subjects in this group will receive a placebo patch and will not receive contingency management
    Intervention: Behavioral: Cognitive Behavioural Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
January 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
14 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01145001
020718574, P50DA009241-17
Yes
Yale University
Yale University
National Institutes of Health (NIH)
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP