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OpenTrials
Completed

NCT Number: NCT01145001

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.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders Tobacco Use Disorder

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMHC

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

Weekly CBT for all subjects

Contingency Management

Behavioral

incentives given for abstinence based on urine analysis

Nicotine transdermal patch

Drug

14mg ir 21mg doses based on weight and #cigs/day

Other names: Habitrol

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Contingency Management for Smoking Cessation in Adolescent Smokers - Phase IV, Enhancing a High School Based Smoking Cessation Program

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Jun 16, 2010
Registry last updated
Dec 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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