Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt
NCT00571805
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- At least 10 cigarettes/day
- Interest in quitting smoking
- Willgness to comply with overnight smoking abbstiennce period followed by lab smoking test
- Pregnancy
- Axis I psychiatric disorder which require treatment with psychoactive medication and
would make study compliance difficult.
- Clinically significant medical condition in opinion of study clinician
- Drug or alcohol dependence inlast 12 months
- Use of other smoking cessation medications ot treatment progams in last 2 months
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Descriptive Information | ||||
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Brief Title ICMJE | Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt | |||
Official Title ICMJE | Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement | |||
Brief Summary | Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on Day 8 and a 1 week quit attempt from Day 8-14. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | |||
Condition ICMJE | Nicotine Dependence | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE | 0 | |||
Original Estimated Enrollment ICMJE | 40 | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
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 | NCT00571805 | |||
Other Study ID Numbers ICMJE | Varenicline/Smoking GA30513U | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Malcolm S. Reid, PhD, New York University School of Medicine | |||
Study Sponsor ICMJE | NYU Langone Health | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | NYU Langone Health | |||
Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |