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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

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).

Condition or disease Intervention/treatment Phase
Nicotine Dependence Behavioral: Varenicline Standard Protocol Behavioral: Nicotine Patch Standard Protocol Drug: Varenicline Adaptive Protocol Drug: Nicotine Adaptive Protocol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
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
Official Title: Randomized Controlled Smoking Cessation Trial on Adaptive Pharmacotherapy
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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

  4. Change in cigarettes smoked per day (phone) [ Time Frame: 1 week post-TQD, 52 weeks post-TQD ]
    Assessed via single-item question.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02501265


Locations
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United States, North Carolina
Duke Center for Smoking Cessation
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
Pfizer
Investigators
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Principal Investigator: James M Davis, M.D. Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02501265    
Other Study ID Numbers: Pro00072077
P50DA027840 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
Nicotine addiction
Cigarette smoking
Bupropion
Varenicline
Adaptive Approach
Nicotine Patch
Chantix
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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