Clinical trial NCT02501265: Adaptive Pharmacotherapy for Smoking Cessation
Official title: Randomized Controlled Smoking Cessation Trial on Adaptive Pharmacotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Keywords: Nicotine addiction
Cigarette smoking
Bupropion
Varenicline
Adaptive Approach
Nicotine Patch
Chantix
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Pfizer
First posted: 2015-07-17
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Biochemically-confirmed 30-day Continuous Smoking Abstinence
timeFrame: 12 weeks post-TQD (Visit 4)
Secondary outcomes:
measure: 7-day Point Prevalence Biochemically Confirmed Abstinence
timeFrame: 12 weeks post-TQD (Visit 4)
measure: Phone-assessed Self-reported Abstinence
timeFrame: 52 weeks post-TQD
measure: Change in Cigarettes Smoked Per Day
timeFrame: 12 weeks post-TQD (Visit 4)
measure: Change in Cigarettes Smoked Per Day (Phone)
timeFrame: 52 weeks post-TQD
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Smoking Cessation
state: North Carolina
Study officials:
affiliation: Duke University
name: James M Davis, M.D.
role: PRINCIPAL_INVESTIGATOR
References: