Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation
NCT ID: NCT02697227
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
85 participants
INTERVENTIONAL
2016-08-05
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
Laboratory Biomarker Analysis
Correlative studies
Nicotine Patch
Receive nicotine patch
Questionnaire Administration
Ancillary studies
Smoking Cessation Intervention
Receive standard smoking cessation counseling
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.
Behavioral Intervention
Receive BATS counseling
Laboratory Biomarker Analysis
Correlative studies
Nicotine Patch
Receive nicotine patch
Questionnaire Administration
Ancillary studies
Interventions
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Behavioral Intervention
Receive BATS counseling
Laboratory Biomarker Analysis
Correlative studies
Nicotine Patch
Receive nicotine patch
Questionnaire Administration
Ancillary studies
Smoking Cessation Intervention
Receive standard smoking cessation counseling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jennifer A Minnix
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2016-00674
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0879
Identifier Type: OTHER
Identifier Source: secondary_id
2015-0879
Identifier Type: -
Identifier Source: org_study_id