Relapse Prevention With Varenicline

Completed · Phase 4 · Has a placebo group

Conditions studied: Recurrence, Smoking Cessation, Substance-Related Disorders

In brief

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.

Key facts

Study ID

NCT00944554

Run by

Johns Hopkins University

People needed

104

Starts

2008-10-01

Expected to finish

2011-05-01

Last updated by the study team

2017-08-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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