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Coping Skills Treatment for Smoking Cessation (Project-WIN)

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transdermal Nicotine
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring cigarette smoking, smoking cessation, nicotine dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-65 years old
  • regular smoker for at least one year
  • currently smoking 10 or more cigarettes per day

Exclusion Criteria:

  • Current Axis I disorder
  • Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
  • Current suicidal risk
  • Pregnancy or breast feeding
  • Use of nicotine replacement products or bupropion

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New Smoking Cessation Counseling

Standard Smoking Cessation Counseling

Arm Description

One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.

One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.

Outcomes

Primary Outcome Measures

Number of Participants With Biochemically Verified Smoking Abstinence
Carbon monoxide of expired air Salivary cotinine level of saliva

Secondary Outcome Measures

Full Information

First Posted
February 2, 2010
Last Updated
September 17, 2018
Sponsor
Butler Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01061528
Brief Title
Coping Skills Treatment for Smoking Cessation
Acronym
Project-WIN
Official Title
Distress Tolerance Treatment for Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.
Detailed Description
18-65 years of age, a regular smoker for at least one year, currently smoking 10 or more cigarettes per day, report motivation to quit smoking in the next month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
cigarette smoking, smoking cessation, nicotine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New Smoking Cessation Counseling
Arm Type
Experimental
Arm Description
One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Arm Title
Standard Smoking Cessation Counseling
Arm Type
Active Comparator
Arm Description
One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Intervention Type
Drug
Intervention Name(s)
Transdermal Nicotine
Other Intervention Name(s)
Nicoderm CQ
Intervention Description
Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.
Primary Outcome Measure Information:
Title
Number of Participants With Biochemically Verified Smoking Abstinence
Description
Carbon monoxide of expired air Salivary cotinine level of saliva
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-65 years old regular smoker for at least one year currently smoking 10 or more cigarettes per day Exclusion Criteria: Current Axis I disorder Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year Current suicidal risk Pregnancy or breast feeding Use of nicotine replacement products or bupropion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Brown, PhD
Organizational Affiliation
Butler Hospital/Brown Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Coping Skills Treatment for Smoking Cessation

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