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Clinical Trials/NCT01061528
NCT01061528
Completed
Not Applicable

Distress Tolerance Treatment for Smoking Cessation

Butler Hospital1 site in 1 country116 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Transdermal Nicotine
Conditions
Nicotine Dependence
Sponsor
Butler Hospital
Enrollment
116
Locations
1
Primary Endpoint
Number of Participants With Biochemically Verified Smoking Abstinence
Status
Completed
Last Updated
7 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
October 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

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: Transdermal Nicotine

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: Transdermal Nicotine

Outcomes

Primary Outcomes

Number of Participants With Biochemically Verified Smoking Abstinence

Time Frame: Six months

1. Carbon monoxide of expired air 2. Salivary cotinine level of saliva

Study Sites (1)

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