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Enhancing a High School Based Smoking Cessation Program

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Contingency Management
Nicotine Transdermal Patch
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring smoking, adolescents, contingency management, nicotine replacement therapy

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CMHC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Active Nicotine Patch and Contingency Management

Nicotine Patch with no Contingency Management

Placebo patch and Contingency Management

Placebo Patch and no Contingency Management

Arm Description

Subjects in this group will receive Contingency Management and active nicotine patch

Subjects in this group will receive active nicotine patch without contingency management for abstinence

Subjects in this group will receive a placebo transdermal patch and contingency management

Subjects in this group will receive a placebo patch and will not receive contingency management

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Continuous Abstinence During Treatment
We will also examine continuous abstinence during the six week treatment period by urine analysis each week.

Full Information

First Posted
June 14, 2010
Last Updated
November 4, 2016
Sponsor
Yale University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01145001
Brief Title
Enhancing a High School Based Smoking Cessation Program
Official Title
Contingency Management for Smoking Cessation in Adolescent Smokers - Phase IV, Enhancing a High School Based Smoking Cessation Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
smoking, adolescents, contingency management, nicotine replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Nicotine Patch and Contingency Management
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive Contingency Management and active nicotine patch
Arm Title
Nicotine Patch with no Contingency Management
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive active nicotine patch without contingency management for abstinence
Arm Title
Placebo patch and Contingency Management
Arm Type
Placebo Comparator
Arm Description
Subjects in this group will receive a placebo transdermal patch and contingency management
Arm Title
Placebo Patch and no Contingency Management
Arm Type
Placebo Comparator
Arm Description
Subjects in this group will receive a placebo patch and will not receive contingency management
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
Weekly CBT for all subjects
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
incentives given for abstinence based on urine analysis
Intervention Type
Drug
Intervention Name(s)
Nicotine Transdermal Patch
Other Intervention Name(s)
Habitrol
Intervention Description
14mg ir 21mg doses based on weight and #cigs/day
Primary Outcome Measure Information:
Title
Abstinence Rates at the End of Treatment
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Continuous Abstinence During Treatment
Description
We will also examine continuous abstinence during the six week treatment period by urine analysis each week.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suchitra Krishnan-Sarin, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMHC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Enhancing a High School Based Smoking Cessation Program

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