NCT02501265

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 13, 2021

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

3.2 years

First QC Date

June 30, 2015

Results QC Date

July 21, 2021

Last Update Submit

August 17, 2021

Conditions

Nicotine Dependence

Keywords

Nicotine addictionCigarette smokingBupropionVareniclineAdaptive ApproachNicotine PatchChantix

Outcome Measures

Primary Outcomes (1)

  • Biochemically-confirmed 30-day Continuous Smoking Abstinence

    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.

    12 weeks post-TQD (Visit 4)

Secondary Outcomes (4)

  • 7-day Point Prevalence Biochemically Confirmed Abstinence

    12 weeks post-TQD (Visit 4)

  • Phone-assessed Self-reported Abstinence

    52 weeks post-TQD

  • Change in Cigarettes Smoked Per Day

    12 weeks post-TQD (Visit 4)

  • Change in Cigarettes Smoked Per Day (Phone)

    52 weeks post-TQD

Study Arms (4)

Varenicline Standard Protocol

ACTIVE COMPARATOR

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

Nicotine Patch Standard Protocol

ACTIVE COMPARATOR

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

Varenicline Adaptive Protocol

EXPERIMENTAL

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

Nicotine Patch Adaptive Protocol

EXPERIMENTAL

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

Interventions

Varenicline Standard ProtocolBEHAVIORAL

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

Also known as: Standard Varenicline
Varenicline Standard Protocol
Nicotine Patch Standard ProtocolBEHAVIORAL

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

Also known as: Standard Nicotine Patch
Nicotine Patch Standard Protocol
Varenicline Adaptive ProtocolDRUG

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

Also known as: Adaptive Varenicline
Varenicline Adaptive Protocol
Nicotine Adaptive ProtocolDRUG

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

Also known as: Adaptive Nicotine
Nicotine Patch Adaptive Protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Center for Smoking Cessation

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • Davis JM, Masclans L, Rose JE. Adaptive Smoking Cessation Using Precessation Varenicline or Nicotine Patch: A Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332214. doi: 10.1001/jamanetworkopen.2023.32214.

    PMID: 37682573DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderCigarette Smoking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersTobacco SmokingSmokingBehaviorTobacco Use

Results Point of Contact

Title
Dr. James Davis
Organization
Duke University School of Medicine
james.m.davis@duke.edu
919-668-5055

Study Officials

  • James M Davis, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 17, 2015

Study Start

June 6, 2017

Primary Completion

July 30, 2020

Study Completion

May 12, 2021

Last Updated

August 19, 2021

Results First Posted

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)