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Varenicline and Combined Nicotine Replacement Therapy (NRT) for Smoking Cessation

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tobacco Use Cessation

Intervention: Varenicline (Drug); Placebo Patch (Other); Nicotine Patch (Drug); Placebo Lozenges (Other); Nicotine Lozenge (Drug); Questionnaires (Behavioral); Counseling (Behavioral); Phone Calls (Behavioral)

Phase: Phase 4

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Paul Cinciripini, PHD, MS, BS, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Paul Cinciripini, PHD, MS, BS, Phone: 713-792-0919

Summary

Objectives: The goal of this clinical research study is to test two therapies that may help people quit smoking to determine if one is more effective than the other. The two therapies are Chantix (varenicline) and a combination of a nicotine patch and nicotine lozenge. For subjects who have not achieved smoking abstinence after 6 weeks, the objective is to determine if it is more effective to continue with the same therapy, change the therapy or augment the current therapy with an increased dose. Aim 1: To estimate the main effects of varenicline 2mg (VAR) and nicotine patch + lozenge (NPL) on smokers who remain on these medications throughout the trial. Aim 2: To estimate the probability that abstinence at twelve weeks as a function of treatment assignment at six weeks (augmentation) is moderated by initial treatment assignment (i. e. at baseline). Aim 3: To estimate the probability that abstinence at twelve weeks as a function of treatment assignment at six weeks (switching) is moderated by initial treatment assignment (i. e. at baseline). Aim 4: To estimate the probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge (NPL) for six weeks. Aim 5: To estimate the probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with VAR for six weeks.

Clinical Details

Official title: Varenicline and Combined Nicotine Replacement Therapy (NRT) for Initial Smoking Cessation and Rescue Treatment in Smokers: A Randomized Pilot Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Smoking Abstinence

Detailed description: Project STAR Pilot: Study Groups: Weeks 1-6: If you are found to be eligible to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to either group.

- If you are in Group 1, you will receive varenicline.

- If you are in Group 2, you will receive nicotine patches and lozenges.

Weeks 7-12: If you have quit smoking, you will stay in the group you were assigned to during the first 6 weeks of the study. If you have not quit smoking, after 6 weeks in the study, you will again be randomly assigned (as in a roll of dice) to 1 of 3 new study groups. You will have an equal chance of being assigned to Groups 3, 4, or 5.

- If you are in Group 3, you will continue on the same drug (varenicline or nicotine

patch/lozenges) that you were assigned at the beginning of the study.

- If you are in Group 4, you will switch to the patch and lozenges if you were receiving

varenicline, and to varenicline if you were receiving the patch and lozenges.

- If you are in Group 5, you will receive an extra dose of the same drug that you were

assigned at the beginning of the study, so you will take 1 extra dose of varenicline or apply 1 extra nicotine patch each day. Study Drug Administration: You will start taking your assigned study drug(s) on Day 9 (the day after Visit 1). You should take varenicline tablets by mouth with a cup (8 ounces) of water after eating a full meal. You should apply the nicotine patch to the upper arm. You should put it in a slightly different place each day to avoid skin irritation. You may take the patch off at night to avoid problems sleeping. You may take the nicotine lozenges as needed throughout the day. You will be given a study diary to record how many cigarettes you smoke (if any) each day while you are on study. You must return your study diary and any unused study drugs, patches, lozenges, and/or containers at each study visit. Weeks 1-6: On Days 9-11, you will put 1 patch on your arm each morning or take 1 tablet of varenicline each morning. Starting on Day 12, and then every day after that you will take 1 tablet of varenicline in the morning and 1 tablet in the evening or you will continue to put 1 patch on your arm in the morning. Study Visits: At every study visit (Days 8, 17, 24, 38, 50, 59, and 73):

- You will complete questionnaires about several topics, including depression, suicide,

your smoking behavior, and any effects from the study drug. These questionnaires should take about 30-45 minutes in total to complete. You may complete the questionnaires verbally with a study staff person (either on the phone or in person, depending on the visit number) or electronically on your computer using a website administered by Qualtrics.

- You will receive counseling about quitting smoking, where you will talk about possible

"triggers" for smoking and strategies for dealing with quitting smoking. These sessions will take about 15 minutes each. At Visits 1, 5, and 6 (Days 8, 50, and 59):

- Saliva will be collected for a routine test to check your cotinine levels. Cotinine is

a chemical released in your body when it breaks down nicotine and will show whether and how much you have recently smoked.

- Your CO level and weight will be measured.

- At Visit 1 (if you did not already have it at Visit 0), you will have a physical exam.

- At Visits 1 and 5, if you can become pregnant, urine will be collected for a pregnancy

test. During your first counseling session (Visit 1), you will set a "quit date" for stopping smoking for about 1 week after you start taking the study drug. You should not quit smoking before the quit date. You may also set goals to reduce smoking. You will also be given a drug instruction sheet, a card with emergency contact information, and a participant manual to help you follow along with the topics discussed during counseling. Visits 2, 3, 4, and 7 (on Days 17, 24, 38, and 73) will be done over the phone with questionnaires completed either electronically or by phone. You will complete questionnaires about several topics including depression, mood, your smoking behavior, and any effects from the study drug. You will also be asked about any drugs you may be taking. Each phone visit, including the verbal or electronic questionnaire session, should take about 25-45 minutes. The study staff will call you 1 day before your quit date, 3 days after your quit date, 3 days after Visit 5, and 14 days after Visit 5 to check on your progress in quitting smoking. Each call should take about 10-15 minutes. Length of Study: You will receive the study drug tablets, patches, and lozenges for up to 12 weeks. You will be taken off study early if the doctor thinks it is in your best interest or if you are unable to follow study directions. Your participation on the study will be over after the follow-up visits. End-of-Treatment Visit (Visit 8/Day 94): After you have finished taking the study drug, the following tests and procedures will be performed:

- Your CO level and weight will be measured.

- Blood (about 2 teaspoons) will be drawn to check your liver and kidney function.

- Saliva will be collected to measure your cotinine level.

- You will complete the same questionnaires you completed at the regular study visits.

- You will receive counseling about quitting smoking.

- If you can become pregnant, urine will be collected for a pregnancy test.

Follow-Up Visits (Visits 9 and 10): At about 3 and 6 months after you have stopped smoking, the following tests and procedures will be performed:

- Your CO level and weight will be measured.

- Saliva will be collected to measure your cotinine level.

- You will complete the same questionnaires you completed at the regular study visits.

This is an investigational study. Varenicline, the nicotine patch, and the nicotine lozenge are FDA approved and commercially available to help people stop smoking. The study doctor can explain how the study drugs are designed to work. Up to 10 participants will take part in this portion of the study. All will be enrolled at MD Anderson. Project STAR: Study Groups: Weeks 1-6: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups for the first 6 weeks you are on study. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to either group.

- Participants in Group 1 will receive varenicline tablets, placebo patches, and placebo

lozenges. A placebo is not a drug. It looks like the study drugs but is not designed to treat any disease or illness. It is designed to be compared with a study drugs to learn if the study drug has any real effect.

- Participants in Group 2 will receive placebo tablets, nicotine patches, and nicotine

lozenges. You will also have a physical exam during Week 1 if you did not have one at screening. Weeks 7-12: If you have quit smoking, you will stay in the group you were assigned to for the first 6 weeks of the study. If you have not quit smoking, after 6 weeks in the study, you will again be randomly assigned (as in a roll of dice) to 1 of 3 new study groups. You will have an equal chance of being assigned to Groups 3, 4, or 5.

- Participants in Group 3 will continue on the same kind of tablets

(varenicline/placebo), patches (nicotine/placebo), and lozenges that you were assigned at the beginning of the study. You will also take an extra placebo tablet with your evening dose, and you will apply an extra placebo patch every day.

- Participants in Group 4 will be switched to a different active therapy. This means that

if you were taking varenicline tablets (and placebo patches and lozenges), you will now take placebo tablets and active patches and lozenges. If you were taking placebo tablets (and active patches and lozenges), you will now take varenicline tablets and placebo patches and lozenges . You will also receive an extra placebo tablet with your evening dose and you will apply an extra placebo patch every day.

- Participants in Group 5 will receive an extra dose of the same tablet

(varenicline/placebo) that you were assigned at the beginning of the study. You will also apply 1 additional patch (nicotine/placebo) each day and continue taking the same type of lozenge (active or placebo). Participants in all 3 groups will take 6 tablets, use 2 patches, and take lozenges as needed for days 1-7 in Week 7. In Weeks 8-12, participants will take 3 tablets, use 2 patches, and take lozenges as needed. However, neither you nor the study doctor will know which group you are assigned to. If needed for your safety, the study staff will be able to find out what you are receiving. Study Drug Administration: You will begin taking the study drug/placebo the day after Visit 1. You should take varenicline/placebo tablets by mouth with a cup (8 ounces) of water after eating a full meal. You should apply the nicotine/placebo patch to the upper arm. You should put it in a slightly different place each day to avoid skin irritation. You may take the patch off at night to avoid problems sleeping. You may take the nicotine/placebo lozenges as needed throughout the day. You will be given a study diary to record how many cigarettes you smoke (if any) each day while you are on study. You must return your study diary and any unused study drugs, patches, lozenges, and/or containers at each study visit. Weeks 1-6: The first 3 days of being on study medication, you will put 1 patch on your arm each morning and take 1 tablet of varenicline/placebo each morning. Starting on the 4th day of study medication, and then every day after that:

- You will take 1 tablet of varenicline/placebo in the morning and 1 tablet in the

evening.

- You will continue to put 1 patch on your arm in the morning.

Study Visits: At every study visit (Visits 1-7):

- You will complete questionnaires about several topics, including depression, suicide,

your smoking behavior, and any effects from the study drug. These questionnaires should take about 30-45 minutes in total to complete. You may complete the questionnaires verbally with a study staff person (either on the phone or in person, depending on the visit number) or electronically on your computer using a website administered by Qualtrics.

- You will receive counseling about quitting smoking, where you will talk about possible

"triggers" for smoking and strategies for dealing with quitting smoking. These sessions will take about 15 minutes each.

- You will be asked about medications that you are taking.

At Visits 1, 5, and 6:

- Saliva will be collected for a routine test to check your cotinine levels. Cotinine is

a chemical released in your body when it breaks down nicotine and will show whether and how much you have recently smoked.

- Your CO level and weight will be measured. At Visit 1, if study staff think it is

needed, urine will be collected for a NicAlert test. A NicAlert test is better at detecting levels of smoking than the CO machine.

- At Visit 1 (if you did not already have it at Visit 0), you will have a physical exam.

- At Visits 1 and 5, if you can become pregnant, urine will be collected for a pregnancy

test. During your first counseling session (at Visit 1), you will set a "quit date" for stopping smoking for about 1 week after you start taking the study drug/placebo. You should not quit smoking before the quit date. You may also set goals to reduce smoking. You will also be given a drug instruction sheet, a card with emergency contact information, and a participant manual to help you follow along with the topics discussed during counseling. Visits 2, 3, 4, and 7 will be done over the phone with questionnaires completed either electronically or by phone. You will complete questionnaires about several topics including depression, mood, your smoking behavior, and any effects from the study drug. You will also be asked about any drugs you may be taking. Each phone visit, including the verbal or electronic questionnaire session, should take about 25-45 minutes. The study staff will call you 1 day before your quit date, 3 days after your quit date, 3 days after Visit 5, and 14 days after Visit 5 to check on your progress in quitting smoking. Each call should take about 10-15 minutes. Length of Study: You will receive the study drug/placebo tablets, patches, and lozenges for up to 12 weeks. You will be taken off study early if the doctor thinks it is in your best interest or if you are unable to follow study directions. Your total study participation from randomization to the end of the final followup visit is approximately 6 months. Your participation on the study will be over after the follow-up visits. End-of-Treatment Visit (Visit 8/Day 94): After you have finished taking the study drug/placebo, the following tests and procedures will be performed:

- Your CO level and weight will be measured.

- Blood (about 2 teaspoons) will be drawn to check your liver and kidney function.

- Saliva will be collected to measure your cotinine level.

- You will complete the same questionnaires you completed at the regular study visits.

- You will receive counseling about quitting smoking.

- If you can become pregnant, urine will be collected for a pregnancy test.

Follow-Up Visits (Visits 9 and 10): At about 3 and 6 months after you have stopped smoking, the following tests and procedures will be performed:

- Your CO level and weight will be measured.

- Saliva will be collected to measure your cotinine level.

- You will complete the same questionnaires you completed at the regular study visits.

This is an investigational study. Varenicline, the nicotine patch, and the nicotine lozenge are FDA approved and commercially available to help people stop smoking. The study doctor can explain how the study drugs are designed to work. Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age: 18-75 years old 2. Smoking 5 or more cigarettes and/or little cigars 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 less than or equal to 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 he/she may be reached 7. Be the only participant in his/her household ExclusionCriteria: 1. Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes or little cigars 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 psychotic

disorder or current 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 (including allergy to latex). 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.

Locations and Contacts

Paul Cinciripini, PHD, MS, BS, Phone: 713-792-0919

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: May 2015
Last updated: August 4, 2015

Page last updated: August 23, 2015

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