ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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)
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Baltimore, Maryland
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Relapse Prevention With Varenicline | |||
Official Title ICMJE | Relapse Prevention With Varenicline | |||
Brief 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. | |||
Detailed Description | In this study, the investigators plan to use an experimental model of a lapse, in which volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this study are to assess the impact of varenicline on the subjective and reinforcing effects of cigarettes, as well as the latency to resume smoking (relapse) following the lapse exposure. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Diagnostic | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 104 | |||
Original Estimated Enrollment ICMJE | 120 | |||
Actual Study Completion Date ICMJE | May 2011 | |||
Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00944554 | |||
Other Study ID Numbers ICMJE | NA_00019900 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Johns Hopkins University | |||
Study Sponsor ICMJE | Johns Hopkins University | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Johns Hopkins University | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |