Adaptive Pharmacotherapy for Smoking Cessation

Nicotine Dependence Clinical Trial

Official title:

Randomized Controlled Smoking Cessation Trial on Adaptive Pharmacotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501265
• Other study ID #: Pro00072077
• Secondary ID: P50DA027840
• Status: Completed
• Phase: Phase 2
• Start date: June 6, 2017
• Est. completion date: May 12, 2021

Study information

• Verified date: August 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: May 12, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

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
• 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

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
• 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

Locations

Country	Name	City	State
United States	Duke Center for Smoking Cessation	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute on Drug Abuse (NIDA), Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7-day Point Prevalence Biochemically Confirmed Abstinence	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)
Secondary	Phone-assessed Self-reported Abstinence	Number of participants who self reported smoking abstinence over the last 24 hours assessed via single-item question.	52 weeks post-TQD
Secondary	Change in Cigarettes Smoked Per Day	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	12 weeks post-TQD (Visit 4)
Secondary	Change in Cigarettes Smoked Per Day (Phone)	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.	52 weeks post-TQD