Clinical trial NCT02697227: Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation
Official title: Low Reward Sensitivity and Behavioral Activation Therapy for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cigarette Smoker
Tobacco Use Disorder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Up to 4 months
measure: Mediators of the behavioral activation treatment for smoking plus nicotine replacement therapy treatment effect in low reward sensitivity- smokers
timeFrame: Up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jennifer A Minnix
role: PRINCIPAL_INVESTIGATOR
References: