Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Varenicline and Combined NRT 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02271919
Recruitment Status : Recruiting
First Posted : October 22, 2014
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE October 17, 2014
First Posted Date  ICMJE October 22, 2014
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE May 14, 2015
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
  • Seven-day point prevalence and treatment or treatment strategy [ Time Frame: At week 6 ]
    Estimated rates of seven-day point prevalence for varenicline and nicotine patch + lozenge at week 6 derive from meta-analyses.
  • Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires [ Time Frame: Up to 12 weeks ]
    Participants complete questionnaires about several topics including depression, mood, smoking behavior, and any effects from the study drug.
  • Probability of response at week 12 conditional on response at week 6 and continuation of treatment [ Time Frame: At 12 weeks ]
    The probability of response at week 12 conditional on response at week 6 and continuation based on clinical consensus, taking into account the marginal rates of response at twelve weeks reported derived from meta-analysis. Monte Carlo simulations (K = 500) determined predictive power for the planned analyses.
  • Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment [ Time Frame: At 12 weeks ]
    The probability of response at week 12 conditional on non-response at week 6 and continuation of treatment based on clinical consensus, taking into account the marginal rates of response at twelve weeks reported derived from meta-analysis. Monte Carlo simulations (K = 500) determined predictive power for the planned analyses.
  • Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment [ Time Frame: At 12 weeks ]
    The probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment based on clinical consensus, taking into account the marginal rates of response at twelve weeks reported derived from meta-analysis. Monte Carlo simulations (K = 500) determined predictive power for the planned analyses.
  • Probability of response at week 12 conditional on non-response at week 6 and treatment switching [ Time Frame: At 12 weeks ]
    The probability of response at week 12 conditional on non-response at week 6 and treatment switching based on clinical consensus, taking into account the marginal rates of response at twelve weeks reported derived from meta-analysis. Monte Carlo simulations (K = 500) determined predictive power for the planned analyses.
  • Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks [ Time Frame: 12 weeks ]
    Monte Carlo simulations (K = 500) determined predictive power for the planned analyses.
  • Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks [ Time Frame: 12 weeks ]
    Monte Carlo simulations (K = 500) determined predictive power for the planned analyses.
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
Smoking Abstinence [ Time Frame: 12 weeks ]
In this study, end of treatment (EOT) seven-day point prevalence abstinence (no smoking for the past 7 days) will serve as the primary outcome measure. In-person reports of abstinence will be verified by expired CO < 10 ppm and/or salivary cotinine of < 15 ng/ml at follow-up.
Change History Complete list of historical versions of study NCT02271919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Varenicline and Combined NRT for Smoking Cessation
Official Title  ICMJE Varenicline and Combined NRT for Initial Smoking Cessation and Rescue Treatment in Smokers: A Randomized Pilot Trial
Brief Summary This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Nicotine replacement therapy consists of nicotine patches and lozenges. It is not yet known if varenicline is more effective than nicotine replacement therapy in helping patients quit smoking.
Detailed Description

PRIMARY OBJECTIVES:

I. To estimate the main effects of varenicline 2 mg (VAR) and nicotine patch + lozenge (NPL) on smokers who remain on these medications throughout the trial.

II. 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).

III. 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).

IV. 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.

V. 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.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive varenicline orally (PO) once daily (QD) or twice daily (BID), placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.

GROUP II: Patients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.

Patients who fail to achieve abstinence at week 6 are re-randomized to receive 6 additional weeks of therapy consisting of either a continuation of the same treatment; switching to the untried intervention (either NPL or varenicline); or receive NPL treatment with an additional patch (high-dose NPL) or high-dose varenicline.

After completion of study treatment, patients are followed up at 3 and 6 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cigarette Smoker
  • Tobacco Use Disorder
Intervention  ICMJE
  • Drug: Nicotine Lozenge
    Given PO
    Other Name: Commit
  • Drug: Nicotine Patch
    Given via patch
    Other Names:
    • NicoDerm CQ
    • Nicotine Skin Patch
    • Nicotine Transdermal Patch
  • Other: Placebo
    Given PO or via patch
    Other Names:
    • placebo therapy
    • PLCB
    • sham therapy
  • Other: Tobacco Cessation Counseling
    Receive behavioral smoking cessation counseling
  • Drug: Varenicline
    Given PO
    Other Names:
    • Champix
    • Chantix
    • CP-526555
Study Arms  ICMJE
  • Experimental: Group I (varenicline and placebo)
    Patients receive varenicline PO QD or BID, placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.
    Interventions:
    • Other: Placebo
    • Other: Tobacco Cessation Counseling
    • Drug: Varenicline
  • Placebo Comparator: Group II (placebo, nicotine patch and lozenge)
    Patients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.
    Interventions:
    • Drug: Nicotine Lozenge
    • Drug: Nicotine Patch
    • Other: Placebo
    • Other: Tobacco Cessation Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2018)
510
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2014)
310
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Smoking 5 or more cigarettes, little cigars and/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 less than or equal to 5, then positive cotinine test)
  • 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 he/she may be reached
  • Be the only participant in his/her household

Exclusion Criteria:

  • 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., 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 meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, nicotine replacement therapy (NRT), Chantix, (2) certain medications 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 pro re nata (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 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, phencyclidine (PCP), or 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; study physician may clear participant to continue on if there is a reasonable possibility the positive drug screen is the result of cross-reactivity with the participant's concomitant medications resulting in a false positive
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Paul Cinciripini 713-792-0919 pcinciri@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02271919
Other Study ID Numbers  ICMJE 2014-0213
NCI-2015-00610 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0213 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Paul Cinciripini M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP