Coping Skills Treatment for Smoking Cessation

Nicotine Dependence Clinical Trial

— Project-WIN  

Official title:

Distress Tolerance Treatment for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061528
• Other study ID #: PHI0906-002
• Secondary ID: R01DA017332
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: October 2013

Study information

• Verified date: September 2018
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Biochemically Verified Smoking Abstinence	Carbon monoxide of expired air; Salivary cotinine level of saliva	Six months