Enhancing a High School Based Smoking Cessation Program

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145001
• Other study ID #: 020718574
• Secondary ID: P50DA009241-17
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: March 30, 2015
• Start date: November 2009
• Est. completion date: January 2015

Study information

• Verified date: June 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: January 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Behavioral:
• Cognitive Behavioural Therapy
Weekly CBT for all subjects
• Contingency Management
incentives given for abstinence based on urine analysis

Drug:
• Nicotine Transdermal Patch
14mg ir 21mg doses based on weight and #cigs/day

Locations

Country	Name	City	State
United States	CMHC	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence rates at the end of treatment	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.	6 weeks	No
Secondary	Abstinence rates during treatment	We will also examine continuous abstinence during the six week treatment period by urine analysis each week.	6 weeks	No