NCT02697227

Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation

Low Reward Sensitivity and Behavioral Activation Therapy for Smoking Cessation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This randomized clinical trial studies how well behavioral activation therapy and nicotine replacement therapy work in increasing smoking cessation. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving behavioral activation therapy and nicotine replacement therapy may help patients quit smoking or change their smoking behavior.

Detailed description

PRIMARY OBJECTIVES: I. To determine the comparative effectiveness of Behavioral Activation Treatment for Smoking (BATS) plus nicotine replacement therapy (NRT) versus standard cessation treatment plus NRT on high reward sensitivity smokers (IRS+) and low reward sensitivity (IRS-) smokers. II. To identify mediators of the BATS plus NRT treatment effect in IRS- smokers. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (STANDARD CESSATION): Patients receive NRT patch daily for 8 weeks. Patients receive individual behavioral treatment sessions consisting of behavioral treatment strategies for smoking cessation and health education information over 45 minutes for 8 sessions. GROUP II (BATS): Patients receive NRT patch daily for 8 weeks. Patients receive individual treatment sessions consisting of standard cessation (SC) strategies and behavioral activation (BA) strategies over 45 minutes for 8 sessions. After completion of study intervention, patients are followed up at 3 months.

Conditions

• Cigarette Smoker
• Tobacco Use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Intervention	Receive BATS counseling
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Nicotine Patch	Receive nicotine patch
OTHER	Questionnaire Administration	Ancillary studies
BEHAVIORAL	Smoking Cessation Intervention	Receive standard smoking cessation counseling

Timeline

• Start date: 2016-08-05
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2016-03-03
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States