Coping Skills Treatment for Smoking Cessation

NCT ID: NCT01061528

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-10-31

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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transdermal Nicotine

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Transdermal Nicotine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Nicoderm CQ

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard A Brown, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital/Brown Medical School

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

R01DA017332

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PHI0906-002

Identifier Type: -

Identifier Source: org_study_id