Behavioral Activation + Nicotine Patches for Smoking Cessation

Overseen by Jennifer A. Minnix

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jennifer A. Minnix

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adult cigarette smokers who smoke at least 5 cigarettes a day, want to quit or change their smoking habits, and can follow instructions in English. They must be the only participant from their household and have contact details. People with uncontrolled high blood pressure, certain neurological conditions, or using specific medications cannot join. Pregnant women or those not using effective birth control are also excluded.

Inclusion Criteria

Be the only participant in their household

Smoking 5 or more cigarettes, little cigars or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm); (if < 6, then NicAlert Strip > 2)

Able to follow verbal and written instructions in English and complete all aspects of the study

Exclusion Criteria

I have not been hospitalized for psychiatric reasons in the last year.

I plan to use nicotine substitutes or smoking cessation treatments soon.

I am not pregnant, post-menopausal for two years, or have had surgery to prevent pregnancy.

Treatment Details

Interventions

• Behavioral Activation Therapy (Behavioural Intervention)
• Nicotine Patch (Nicotine Replacement Therapy)

Trial Overview The study tests whether combining behavioral activation therapy (a method that helps people react differently to triggers) with nicotine patches helps smokers quit or modify their behavior more effectively than other methods.

Participant Groups

Group I: Group I (NRT, SC) Active Control 4 Interventions

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: Group II (NRT, BATS) Active Control 4 Interventions

Patients receive NRT patch daily for 8 weeks. Patients complete individual treatment sessions consisting of SC strategies and BA strategies over 45 minutes for 8 sessions.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School