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.
Full Title of Study: “Low Reward Sensitivity and Behavioral Activation Therapy for Smoking Cessation”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: October 1, 2020
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.
- 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
Arms, Groups and Cohorts
- Active Comparator: Group I (NRT, SC)
- 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.
- Active Comparator: Group II (NRT, BATS)
- 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.
Clinical Trial Outcome Measures
- 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
- Time Frame: Up to 4 months
- Mediators of the behavioral activation treatment for smoking plus nicotine replacement therapy treatment effect in low reward sensitivity- smokers
- Time Frame: Up to 4 months
- 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
Participating in This Clinical Trial
- 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
- 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
- Other medications listed on the exclusionary medications list
- Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse – alcohol addendum-past 6 months only; current alcohol dependence), J (substance abuse – substance abuse addendum – past 6 months only; current substance dependence), K (psychotic disorder or mood disorder with psychotic features); individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the principal investigator
- 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
- Must not have visual problems that in the investigators opinion would interfere in the completion of the study assessments
- Unwilling to change hairstyle or remove a wig as necessary for the appointment to accommodate the net that is required to be worn on the scalp during the study procedure
- Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or phencyclidine (PCP)
- Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded
- Participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return for 90 days
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Jennifer A Minnix, Principal Investigator, M.D. Anderson Cancer Center
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