Adaptive Pharmacotherapy for Smoking Cessation

• Status: Completed
• Trial end date: 2021-05-12
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: National Institute on Drug Abuse (NIDA); Pfizer
• Treatments: Bupropion; Nicotine; Varenicline

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.