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Adaptive 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: NCT02501265
Recruitment Status : Suspended (Enrollment suspended due to COVID-19)
First Posted : July 17, 2015
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Pfizer
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE June 30, 2015
First Posted Date  ICMJE July 17, 2015
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE June 6, 2017
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
Biochemically-confirmed 30-day continuous smoking abstinence [ Time Frame: Enrollment (Visit 1), 12 weeks post-TQD (Visit 4) ]
Self-report abstinence confirmed by carbon monoxide (CO) expired breath testing (CO < 7ppm).
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
Continuous 30-day abstinence from smoking [ Time Frame: Weeks 9-12 post target Quit Day ]
The primary dependent measures will be continuous 30-day abstinence from smoking during the last 30 days of observation in the study, evaluated 12 weeks after the target quit day. This will be determined by a composite of self-report of no smoking on daily diaries and expired air carbon monoxide (CO) <10 ppm (measured at Week 12).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
  • 7-day point prevalence biochemically confirmed abstinence [ Time Frame: 2 weeks post-TQD (Visit 3), 12 weeks post-TQD (Visit 4) ]
    Self-report abstinence confirmed by carbon monoxide (CO) expired breath testing (CO < 7ppm).
  • Phone-assessed self-reported abstinence [ Time Frame: 1 week post-TQD, 52 weeks post-TQD ]
    Assessed via single-item question on smoking during the last 24 hours.
  • Change in cigarettes smoked per day (study visits) [ Time Frame: 2 weeks post-TQD (Visit 3), 12 weeks post-TQD (Visit 4) ]
    Composite self-report diaries
  • Change in cigarettes smoked per day (phone) [ Time Frame: 1 week post-TQD, 52 weeks post-TQD ]
    Assessed via single-item question.
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 Adaptive Pharmacotherapy for Smoking Cessation
Official Title  ICMJE Randomized Controlled Smoking Cessation Trial on Adaptive Pharmacotherapy
Brief Summary The purpose of this study is to assess an "adaptive" approach to smoking cessation pharmacotherapy. The protocol is designed to compare adaptive vs. standard approaches to two common smoking cessation pharmacotherapies - Varenicline (commonly known as Chantix) and the Nicotine Patch. The investigators hypothesize that participants allocated to adaptive therapy will show significantly higher biochemically confirmed 30-day continuous abstinence at 12 weeks post-Target Quit Day (TQD).
Detailed Description The purpose of this study is to assess an "adaptive" approach to smoking cessation pharmacotherapy. The protocol is designed to compare adaptive vs. standard approaches to two common smoking cessation pharmacotherapies (Varenicline and Nicotine Patch). The adaptive treatment approach provides the addition of Bupropion in the pre-quit period for participants who are not "responding" to initial treatment. Little is known about the adaptive use of Varenicline or Nicotine Patch, in which Bupropion is added to Varenicline or Patch for those who do not respond to one of these medications in a pre-quit treatment period. This study attempts to address these knowledge deficits. The study (N=300) is a double-blinded randomized placebo-controlled trial designed to compare biochemically-confirmed abstinence rates in smokers randomized to Varenicline Adaptive Protocol vs. Varenicline (N=150) and for comparison, Nicotine Patch Adaptive Protocol vs. Nicotine Patch (N=150). The "Varenicline Adaptive Protocol" is conducted by starting treatment with Varenicline 4 weeks prior to the quit day and following each participant's response to this pre-treatment medication. After 2 weeks, if the patient shows a reduction greater than 50% in cigarettes smoked per day, then the patient is considered to be a "Varenicline responder" and is continued on Varenicline alone out to 12-weeks post quit day. If the patient does not spontaneously decrease smoking in the pre-quit period by more than 50% cigarettes per day, the patient is considered to be a "Varenicline non-responder" and Bupropion is added to the Varenicline. For comparison, an identical protocol is used with nicotine patch vs. nicotine patch adaptive treatment. The study uses only FDA-approved medications: Varenicline, Nicotine Patch, Bupropion, and placebo controls. To pattern clinical practice, participants will be able to choose whether they would like to use a patch or Varenicline-based treatment. After choosing, however, they will be randomized to adaptive vs. non-adaptive version of that treatment. Placebo medications are matched throughout the study. Participants will be blinded to all medications. All participants will receive behavioral treatment including a single 40-minute visit with a medical provider. The study is designed to provide researchers and clinicians with a better understanding of how to use adaptive pharmacotherapy protocols to improve smoking cessation rates.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The study (N=300) is a double-blinded randomized placebo-controlled trial designed to compare biochemically-confirmed abstinence rates in smokers randomized to Varenicline Adaptive Protocol vs. Varenicline (N=150) and for comparison, Nicotine Patch Adaptive Protocol vs. Nicotine Patch (N=150).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE
  • Behavioral: Varenicline Standard Protocol

    4 weeks pre-TQD: Start Placebo Varenicline

    1 week prior to TQD: Switch to Active Varenicline

    1 week prior to TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD

    Other Name: Standard Varenicline
  • Behavioral: Nicotine Patch Standard Protocol

    4 weeks pre-TQD: Start Placebo Nicotine Patch TQD: Start active Nicotine Patch

    1 week prior to TQD: Start Placebo Bupropion Nicotine Patch + Placebo Bupropion to 12 weeks post TQD

    Other Name: Standard Nicotine Patch
  • Drug: Varenicline Adaptive Protocol

    VARENICLINE RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD

    VARENICLINE NON-RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%

    1 week pre-TQD: Start active Bupropion Varenicline + Bupropion to 12 weeks post TQD

    Other Name: Adaptive Varenicline
  • Drug: Nicotine Adaptive Protocol

    NICOTINE PATCH RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Patch + Placebo Bupropion to 12 weeks post TQD

    NICOTINE PATCH NON-RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%

    1 week pre-TQD: Start Bupropion Patch + Bupropion to 12 weeks post TQD

    Other Name: Adaptive Nicotine
Study Arms  ICMJE
  • Active Comparator: Varenicline Standard Protocol
    Participant choses Varenicline-based treatment and is then randomized to Standard Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts placebo Varenicline. Consistent with Varenicline Standard Treatment, 1 week prior to the TQD the participant will switch to active Varenicline and placebo Bupropion. Participant will continue active Varenicline and placebo Bupropion to 12 weeks post-TQD.
    Intervention: Behavioral: Varenicline Standard Protocol
  • Active Comparator: Nicotine Patch Standard Protocol
    Participant choses Nicotine patch-based treatment and is then randomized to Standard Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts placebo Nicotine Patch. One week prior to TQD, participant will start placebo Bupropion. Consistent with Nicotine Patch Standard Treatment, participant will start active Nicotine Patch on TQD. Participant will continue active Nicotine Patch and placebo Bupropion to 12 weeks post-TQD.
    Intervention: Behavioral: Nicotine Patch Standard Protocol
  • Experimental: Varenicline Adaptive Protocol
    Participant chooses Varenicline treatment and is randomized to Adaptive Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts active Varenicline. Two weeks prior to TQD, cigarettes smoked per day is assessed. If the number of cigarettes smoked per day is reduced by >50%, the participant is considered a Varenicline responder, and starts placebo Bupropion 1 week prior to the TQD. If the participant DOES NOT reduce cigarettes smoked per day by >50%, the participant is considered a Varenicline non-responder and starts active Bupropion 1 week prior to TQD. Varenicline responders will continue active Varenicline and placebo Bupropion to 12 weeks post TQD. Varenicline non-responders will continue active Varenicline and active Bupropion to 12 weeks post TQD.
    Intervention: Drug: Varenicline Adaptive Protocol
  • Experimental: Nicotine Patch Adaptive Protocol
    Participant choses Nicotine treatment and is randomized to Adaptive Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts active Nicotine Patches. Two weeks prior to TQD, cigarettes smoked per day is assessed. If cigarettes smoked per day is reduced by >50%, the participant is considered a Nicotine Patch responder and starts placebo Bupropion 1 week prior to the TQD. If the participant DOES NOT reduce cigarettes smoked per day by >50%, the participant is considered a Nicotine Patch non-responder and starts active Bupropion 1 week prior to the TQD. Nicotine Patch responders will continue active Nicotine Patches and placebo Bupropion to 12 weeks post TQD. Nicotine Patch non-responders will continue active Nicotine Patches and Bupropion to 12 weeks post TQD.
    Intervention: Drug: Nicotine Adaptive Protocol
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 Suspended
Estimated Enrollment  ICMJE
 (submitted: April 14, 2020)
188
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2015)
1500
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Age 18 years or older
  2. Actively smoking 5 or more cigarettes per day for at least one year
  3. Fluency in spoken and written English
  4. Willing to set a quit date within 6 weeks
  5. Access to a telephone
  6. Willingness to take Varenicline OR nicotine patch (patient choice)
  7. Willingness to take Bupropion

Exclusion Criteria

  1. Daily use of a second form of tobacco or nicotine (e.g. e-cigarettes, cigars, chewing tobacco, snuff).
  2. Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, Bupropion).
  3. Report of pregnancy, attempting to get pregnant, or actively breast feeding or positive urine pregnancy test (only given to females with child bearing potential).
  4. Additional criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02501265
Other Study ID Numbers  ICMJE Pro00072077
P50DA027840 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Pfizer
Investigators  ICMJE
Principal Investigator: James M Davis, M.D. Duke University
PRS Account Duke University
Verification Date June 2020

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