Behavioral Counseling and Nicotine Replacement Therapy or Varenicline in Helping Smokers Quit
- 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 =< 5, 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 12 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 12 months
- Uncontrolled hypertension (systolic blood pressure; SBP greater than 180 or diastolic blood pressure; DBP greater than 110)
- History of severe kidney disease (e.g. chronic or acute kidney failure) with creatinine clearance below 30 and/or severe liver disease with liver tests over 4 times the upper normal level
- Laboratory evaluations (kidney and liver) outside normal limits and of potential clinical significance in the opinion of the investigator
- Serious or unstable disease within the past 3 months
- History (last 3 months) of abnormal heart rhythms, cardiovascular disease (stroke, angina, heart attack) may result in ineligibility; these conditions will be evaluated on a case by case basis by the study physician
- Current use of certain medications: (1) smoking cessation medications (meds) (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix, (2) certain medications used to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however as needed (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month’s duration)
- 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 (current/lifetime psychotic disorder or current/lifetime 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 and/or study physician
- 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 of 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 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 varenicline, NRT, or any component of these formulations
- Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician
- Subject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the study
- Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, phencyclidine (PCP), or delta-9-tetrahydrocannabinol (THC); A: participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; B: participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return
- 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
- Reports diagnosis of seizure disorder or a history of neurological illness or closed head injury that in the opinion of the principal investigator (PI) feels that it would affect the results of the electroencephalogram (EEG)
I. To conduct a (proof of concept) clinical trial comparing the effectiveness of varenicline versus (vs.) nicotine replacement therapy (NRT: patch) for smoking cessation among smokers high (intrinsic reward sensitivity [IRS]+) and low (IRS-) in reward sensitivity.
II. To evaluate the relationship between late positive potential (LPP) defined reward sensitivity and other measures of reward system deficiency including anhedonia and reward valuation.
OUTLINE: Participants are randomized to 1 of 2 treatment arms.
ARM I: Participants receive varenicline orally (PO) twice daily (BID) for 12 weeks (once daily [QD] on days 1-3 of week 1). Beginning on day 8, participants also receive placebo NRT patch for 11 weeks.
ARM II: Participants receive varenicline placebo PO BID for 12 weeks (QD on days 1-3 of week 1). Beginning on day 8, participants also receive NRT patch for 11 weeks.
In both arms, participants undergo brief individual behavioral smoking cessation counseling per recommended standard for use with pharmacotherapy during the 12 week active treatment phase, consisting of 4 in-person counseling visits, 4 telephone call visits, and 2 brief supportive telephone calls.
After completion of study treatment, participants are followed up at 3 and 6 months.
Trial Phase Phase IV
Trial Type Prevention
M D Anderson Cancer Center
- Primary ID 2014-0207
- Secondary IDs NCI-2014-01485
- Clinicaltrials.gov ID NCT02162849