Phase 4
Completed N=104
Relapse Prevention With Varenicline
Recurrence · Smoking Cessation · Substance-Related Disorders
Source: ClinicalTrials.gov NCT00944554 ↗
Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Days to Relapse — 9.1; 16.4 days
◆ Published Evidence
Established
72citations · ~24 / year
Nicotine receptor partial agonists for smoking cessation.
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.
Linked Publications
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Nicotine receptor partial agonists for smoking cessation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days to Relapse |
9.1; 16.4 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00944554) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.