Reward Sensitivity and Pharmacotherapy for Smoking Cessation
The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
3 other identifiers
interventional
204
1 country
1
Brief Summary
The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2014
CompletedFirst Posted
Study publicly available on registry
June 13, 2014
CompletedStudy Start
First participant enrolled
December 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
February 9, 2026
February 1, 2026
12.2 years
June 11, 2014
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Continuous Nicotine Abstinence
Continuous abstinence over the last 4 weeks of treatment (i.e. EOT-end of treatment) will serve as the primary outcome measure. Saliva will be collected to measure cotinine level.
8 weeks
Secondary Outcomes (1)
Continuous and Prolonged Nicotine Abstinence
3 months
Study Arms (2)
Varenicline + Placebo Patch
EXPERIMENTALVarenicline dosing follows the recommended 12 week course: 0.5 milligram mg/day by mouth for Days 1-3, 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter. Participant takes Varenicline 1-10 days after Visit 1. Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day. Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape. Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
Nicotine Patch + Placebo Tablet
EXPERIMENTALParticipant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening. Starting on Day 8, and then every day after that, participant applies 1 nicotine patch. Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
Interventions
Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day for 11 weeks.
Varenicline Dosing: 0.5 mg/day by mouth for Days 1-3; 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter.
Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11 weeks.
Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. Questionnaires should take about 30-45 minutes total to complete. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. These sessions take about 15 minutes each time.
Participant asked to watch slides. During the lab session, brain electrical activity checked with an electroencephalogram (EEG). Participant completes computer tasks, including questionnaires, that will measure emotions and attention level. These tasks should take about 90 minutes to complete. The lab session may last up to 2 hours.
Saliva tested to check cotinine level at baseline, on Days 8 and 17, end of treatment visit, and at 3 months and 6 months after quitting smoking.
Eligibility Criteria
You may qualify if:
- Age: 18-75 years old
- Smoking 5 or more cigarettes, Little cigars and/or cigarillos per day, on average, within the 2 months preceding the screening visit and expired CO ≥ 6ppm (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
You may not qualify if:
- Standard criteria for transdermal nicotine and varenicline smoking cessation trials will be used.
- Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars and/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., OTC or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months
- Uncontrolled hypertension (SBP greater than 180 or 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 PI feels that it would affect the results of the EEG
- 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 meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, NRT, Chantix, (2) Certain medications to treat depression (last 14 days), i.e.
- 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 postmenopausal, 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 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, PCP, or 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- NAL PHARMAcollaborator
- Pfizercollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVEDHartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PMID: 34611902DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason D Robinson, PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2014
First Posted
June 13, 2014
Study Start
December 14, 2015
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
February 28, 2028
Last Updated
February 9, 2026
Record last verified: 2026-02