Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation

NCT02697227 | Active Not Recruiting

• 3 other identifiers: 2015-0879NCI-2016-00674R34DA037391
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cigarette Smoker; Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

• Effectiveness of behavioral activation treatment for smoking plus nicotine replacement therapy versus standard cessation treatment plus nicotine replacement therapy defined as abstinence rate in low reward sensitivity- and + smokers

  Up to 4 months

• Mediators of the behavioral activation treatment for smoking plus nicotine replacement therapy treatment effect in low reward sensitivity- smokers

  The primary outcome measure is cigarettes per day (CPD) as measured by Time Line Follow Back. This self-report will be biochemically verified by either carbon monoxide breath sample or nicotine sample

  Up to 4 months

Study Arms (2)

Group I (NRT, SC)

ACTIVE COMPARATOR

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.

Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention

Group II (NRT, BATS)

ACTIVE COMPARATOR

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.

Behavioral: Behavioral Intervention; Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Group I (NRT, SC); Group II (NRT, BATS)

Nicotine Patch DRUG

Receive nicotine patch

Also known as: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch

Group I (NRT, SC); Group II (NRT, BATS)

Smoking Cessation Intervention BEHAVIORAL

Receive standard smoking cessation counseling

Also known as: Smoking and Tobacco Use Cessation Interventions

Group I (NRT, SC)

Behavioral Intervention BEHAVIORAL

Receive BATS counseling

Also known as: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, BEHAVIORAL THERAPY, Behavioral Treatment, Behavioral Treatments

Group II (NRT, BATS)

Questionnaire Administration OTHER

Ancillary studies

Group I (NRT, SC); Group II (NRT, BATS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Interested in treatment that might change smoking behavior
• Able to follow verbal and written instructions in English and complete all aspects of the study
• Provide informed consent and agree to all assessments and study procedures
• Have an address and telephone number where they may be reached
• Be the only participant in their household

You may not qualify if:

• Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
• Current enrollment or plans to enroll in another smoking cessation program in the next 6 months
• Plan to use other nicotine substitutes (i.e., over-the-counter \[OTC\] or prescription medication for smoking cessation) or smoking cessation treatments in the next 6 months
• Uncontrolled hypertension (systolic blood pressure \[SBP\] greater than 180 or diastolic blood pressure \[DBP\] greater than 110)
• Reports diagnosis of seizure disorder or a history of neurological illness or closed head injury that in the opinion of the principal investigator (PI) or designated expert(s) feels that it would affect the results of the electroencephalogram (EEG)
• Current use of certain medications:
• Smoking cessation meds (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix
• Certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (amitriptyline), or
• Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by module B of the MINI
• Psychiatric hospitalization within 1 year of screening date
• A positive urine pregnancy test during the screening period; women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
• Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
• History of hypersensitivity or allergic reaction to NRT, or any component of its formulation
• Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator
• Subject considered by the investigator as unsuitable candidate for receipt of NRT, or unstable to be followed up throughout the entire duration of the study

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Behavior Therapy; Tobacco Use Cessation Devices; Nicotine; Smoking Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jennifer A Minnix

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 3, 2016
• Study Start: August 5, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)