Smoking Cessation Clinical Trial
— 0815Official title:
Relapse Prevention With Varenicline
Verified date | July 2017 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Behavioral Pharmacology Research Unit | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days to Relapse | Number of days following the programmed lapse exposure until relapse to smoking occurred | 4 weeks |
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