Adaptive Pharmacotherapy for Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline Standard Protocol; Nicotine Patch Standard Protocol; Varenicline Adaptive Protocol; Nicotine Adaptive Protocol
Intervention description: 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; 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; 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 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
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nicotine addiction; Cigarette smoking; Bupropion; Varenicline; Adaptive Approach; Nicotine Patch; Chantix

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).
    

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.