ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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.
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Descriptive Information | |||||||
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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 |
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Study Arms ICMJE |
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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 | 188 | ||||||
Original Estimated Enrollment ICMJE | 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
Exclusion Criteria
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Duke University | ||||||
Study Sponsor ICMJE | Duke University | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Duke University | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |