Relapse Prevention With Varenicline

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Pfizer
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Age 18-75 years old

• Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests positive for nicotine metabolites at intake

• Contemplating a smoking cessation attempt in the near future

• Willing to engage in a practice quit attempt during which they will be asked to smoke on one occasion

• Able to give informed consent

Exclusion Criteria:

• Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression, bi-polar disorder, or schizophrenia

• History of attempted suicide or expresses any current suicidal ideation

• Pregnant, breast feeding, or planning to become pregnant within the next 3 months

• Reports desire for immediate treatment of tobacco/nicotine dependence

• Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)