Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

• Status: Completed
• Trial end date: 2019-06-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Pilot feasibility study is to find out the effect of different behavioral treatments along with different duration of a drug called varenicline, on smoking behavior and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that has been shown to help people quit smoking.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: James and Esther King Biomedical Research Program; Pfizer
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• ≥18 years of age

• Smoke at least 10 cigarettes daily for the past year

• Expired-air carbon monoxide (CO) > 8 ppm

• Medically eligible to receive varenicline

• Score at least a 5 on the Contemplation Ladder (Biener & Abrams 1991), a measure of motivation to quit smoking.

Exclusion Criteria:

• Are pregnant or lactating

• Have renal dysfunction

• Have a history of seizures

• Are medically at risk in the judgment of the study physician

• Have ever used varenicline

• Have used other smoking cessation medications within the past three months

• Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders)

• Have substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview [MINI]; Sheehan et al 2015).

• We must limit the number of participants from the same street address to 1.