- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02501265
Adaptive Pharmacotherapy for Smoking Cessation
Randomized Controlled Smoking Cessation Trial on Adaptive Pharmacotherapy
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
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Durham, North Carolina, United States, 27705
- Duke Center for Smoking Cessation
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Age 18 years or older
- Actively smoking 5 or more cigarettes per day for at least one year
- Fluency in spoken and written English
- Willing to set a quit date within 6 weeks
- Access to a telephone
- Willingness to take Varenicline OR nicotine patch (patient choice)
- Willingness to take Bupropion
Exclusion Criteria
- Daily use of a second form of tobacco or nicotine (e.g. e-cigarettes, cigars, chewing tobacco, snuff).
- Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, Bupropion).
- Report of pregnancy, attempting to get pregnant, or actively breast feeding or positive urine pregnancy test (only given to females with child bearing potential).
- Additional criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
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.
|
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 Names:
|
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.
|
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 Names:
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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.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemically-confirmed 30-day Continuous Smoking Abstinence
Time Frame: 12 weeks post-TQD (Visit 4)
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Number of participants who self report complete smoking abstinence over the last 30 days and are also verified to be abstinent by carbon monoxide (CO) expired breath testing with CO < 7 parts per million.
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12 weeks post-TQD (Visit 4)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-day Point Prevalence Biochemically Confirmed Abstinence
Time Frame: 12 weeks post-TQD (Visit 4)
|
Number of participants who self report complete smoking abstinence over the last 7 days and are also verified to be abstinent by carbon monoxide (CO) expired breath testing with CO < 7 parts per million.
|
12 weeks post-TQD (Visit 4)
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Phone-assessed Self-reported Abstinence
Time Frame: 52 weeks post-TQD
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Number of participants who self reported smoking abstinence over the last 24 hours assessed via single-item question.
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52 weeks post-TQD
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Change in Cigarettes Smoked Per Day
Time Frame: 12 weeks post-TQD (Visit 4)
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The percentage of participants who decreased the number of daily cigarettes smoked by 50% or more from the baseline assessment visit to 12 weeks post target quit day assessment visit collected by self-report in participants who completed the 12-week post target quit day assessment visit
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12 weeks post-TQD (Visit 4)
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Change in Cigarettes Smoked Per Day (Phone)
Time Frame: 52 weeks post-TQD
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The percentage of participants who decreased the number of daily cigarettes smoked by 50% or more from the baseline assessment visit to 52 weeks post target quit day assessment visit collected by self-report in participants who completed the 52-week post target quit day phone assessment.
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52 weeks post-TQD
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James M Davis, M.D., Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
- Varenicline
Other Study ID Numbers
- Pro00072077
- P50DA027840 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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