Coping Skills Treatment for Smoking Cessation (Project WIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard Brown, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01061528
First received: February 2, 2010
Last updated: June 10, 2013
Last verified: June 2013

February 2, 2010
June 10, 2013
September 2009
August 2013   (final data collection date for primary outcome measure)
Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Self-reported smoking abstinence via Timeline Followback (TLFB) [ Time Frame: One year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01061528 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Coping Skills Treatment for Smoking Cessation
Distress Tolerance Treatment for Smoking Cessation

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.

  1. 18-65 years of age,
  2. a regular smoker for at least one year,
  3. currently smoking 10 or more cigarettes per day,
  4. report motivation to quit smoking in the next month.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Nicotine Dependence
Drug: Transdermal Nicotine
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.
Other Name: Nicoderm CQ
  • Experimental: New Smoking Cessation Counseling
    • 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: Drug: Transdermal Nicotine
  • Active Comparator: Standard Smoking Cessation Counseling
    • 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: Drug: Transdermal Nicotine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
128
October 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01061528
PHI0906-002, R01DA017332
Yes
Richard Brown, Butler Hospital
Butler Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Richard A Brown, PhD Butler Hospital/Brown Medical School
Butler Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP