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Reward Sensitivity and Pharmacotherapy for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162849
Recruitment Status : Active, not recruiting
First Posted : June 13, 2014
Last Update Posted : May 20, 2019
Sponsor:
Collaborators:
NAL PHARMA
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Drug: Varenicline Drug: Nicotine Patch Drug: Placebo Patch Drug: Placebo Tablet Behavioral: Questionnaires Behavioral: Counseling Sessions Other: Lab Session Other: Saliva Test Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
Actual Study Start Date : December 14, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Varenicline + Placebo Patch

Varenicline 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.

Drug: Varenicline
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.
Other Name: Chantix

Drug: Placebo Patch
Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day for 11 weeks.

Behavioral: Questionnaires
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.
Other Name: Surveys

Behavioral: Counseling Sessions
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.

Other: Lab Session
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.

Other: Saliva Test
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.

Experimental: Nicotine Patch + Placebo Tablet

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.

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.

Drug: Nicotine Patch
Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11 weeks.

Drug: Placebo Tablet
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.
Other Name: Sugar pill

Behavioral: Questionnaires
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.
Other Name: Surveys

Behavioral: Counseling Sessions
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.

Other: Lab Session
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.

Other: Saliva Test
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.




Primary Outcome Measures :
  1. Continuous Nicotine Abstinence [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Continuous and Prolonged Nicotine Abstinence [ Time Frame: 3 months ]
    For prolonged abstinence, relapse defined by 7 or more consecutive days of smoking or smoking at least 1 cigarette over two consecutive weeks from the end of the grace period to a future time point (e.g., EOT, 3- and 6- months post-quit date).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 18-75 years old
  2. 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).
  3. Interested in treatment that might change smoking behavior
  4. Able to follow verbal and written instructions in English and complete all aspects of the study
  5. Provide informed consent and agree to all assessments and study procedures
  6. Have an address and telephone number where they may be reached
  7. Be the only participant in their household

Exclusion Criteria:

  1. 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.
  2. Current enrollment or plans to enroll in another smoking cessation program in the next 12 months
  3. Plan to use other nicotine substitutes ( i.e., OTC or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months
  4. Uncontrolled hypertension (systolic blood pressure; SBP greater than 180 or diastolic blood pressure; DBP greater than 110)
  5. 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
  6. Laboratory evaluations (kidney and liver) outside normal limits and of potential clinical significance in the opinion of the investigator
  7. Serious or unstable disease within the past 3 months
  8. 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.
  9. 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. 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 PRN use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month's duration.
  10. 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.
  11. Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI.
  12. Psychiatric hospitalization within 1 year of screening date.
  13. 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.
  14. 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.
  15. History of hypersensitivity or allergic reaction to Varenicline, NRT, or any component of these formulations.
  16. 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.
  17. 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.
  18. 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.
  19. Must not have visual problems that in the investigators opinion would interfere in the completion of the study assessments
  20. 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.
  21. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162849


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
NAL PHARMA
Pfizer
Investigators
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Principal Investigator: Paul Cinciripini, PHD, MS, BS M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02162849    
Other Study ID Numbers: 2014-0207
NCI-2014-01485 ( Registry Identifier: NCI CTRP )
RP140262 ( Other Grant/Funding Number: CPRIT )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Tobacco Use Cessation
Smoking Cessation
Cancer Prevention
Behavioral Counseling
Nicotine Replacement Therapy
NRT
Nicotine patch
Placebo patch
Placebo pill
Sugar pill
Varenicline
Chantix
Questionnaires
Surveys
Saliva test
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action