N/A N=154 Randomized Double-blind Treatment

Enhancing a High School Based Smoking Cessation Program

Nicotine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01145001 ↗

Enrolled (actual)

154

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcome: Primary: Abstinence Rates at the End of Treatment — 35.1; 24.3; 38.6; 36.1 percentage of participants not smoking

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cognitive Behavioural Therapy (Behavioral); Contingency Management (Behavioral); Nicotine Transdermal Patch (Drug)
Age: Pediatric, Adult · 14+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Abstinence Rates at the End of Treatment	35.1; 24.3; 38.6; 36.1	—
SECONDARY Continuous Abstinence During Treatment	26.1; 26.6; 29; 30	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01145001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.