Coping Skills Treatment for Smoking Cessation (Project-WIN)

Butler Hospital

Status: Completed

Conditions: Nicotine Dependence

Treatments: Drug: Transdermal Nicotine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01061528

PHI0906-002

R01DA017332 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

116 participants in 2 patient groups

New Smoking Cessation Counseling

Experimental group

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.

Treatment:

Drug: Transdermal Nicotine

Standard Smoking Cessation Counseling

Active Comparator group

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.

Treatment:

Drug: Transdermal Nicotine