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
- The sample, 40 women and 40 men, will be hospitalized patients recruited from Stanford Hospital and Clinics who report smoking at least 10 cigarettes per day prior to hospitalization, have confirmed tobacco use by cotinine testing, and an expected hospitalization of at least 3 days duration from the date of study enrollment. Intention to quit smoking will not be required for study participation.
- Study exclusion criteria are: dementia or other brain injury precluding ability to
participate; Alzheimer's Disease; Parkinson's Disease; Huntington's Disease; meningitis;
seizure disorder of a sustained nature; delirium; brain surgery; drug and/or alcohol
dependence; suicidal ideation; end-stage renal disease (i.e., on dialysis); hypertensive
crisis; stroke; myocardial infarction (MI) with severe cardiac damage; pregnancy or
breastfeeding; non-English speaking; complete homelessness; or currently engaged in tobacco
treatment. Study staff will consult with clinical staff prior to approach for study
enrollment. In cases of severe renal impairment (estimated creatinine clearance <30
mL/min), medical staff will consult with participants' physician to assess the
appropriateness for study enrollment.
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Descriptive Information | ||||
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Brief Title ICMJE | Varenicline In-Patient Study | |||
Official Title ICMJE | A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization | |||
Brief Summary | This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2). | |||
Detailed Description | The sample will be hospitalized patients smoking at least 10 cigarettes/day prior to hospitalization. Intention to quit smoking will not be required for study participation. Using a double-blinded, placebo-controlled, randomized design, participants will receive varenicline (0.5 mg BID as tolerated) or placebo during their hospitalization (Part 1) and will continue their study medication (placebo or active drug) for 4 weeks post-hospitalization (Part 2). Abstinence status will be examined at 4 weeks post-hospitalization. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Smoking Cessation | |||
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 | Completed | |||
Actual Enrollment ICMJE | 17 | |||
Original Estimated Enrollment ICMJE | 80 | |||
Actual Study Completion Date ICMJE | October 2014 | |||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Study exclusion criteria are: dementia or other brain injury precluding ability to participate; Alzheimer's Disease; Parkinson's Disease; Huntington's Disease; meningitis; seizure disorder of a sustained nature; delirium; brain surgery; drug and/or alcohol dependence; suicidal ideation; end-stage renal disease (i.e., on dialysis); hypertensive crisis; stroke; myocardial infarction (MI) with severe cardiac damage; pregnancy or breastfeeding; non-English speaking; complete homelessness; or currently engaged in tobacco treatment. Study staff will consult with clinical staff prior to approach for study enrollment. In cases of severe renal impairment (estimated creatinine clearance <30 mL/min), medical staff will consult with participants' physician to assess the appropriateness for study enrollment. | |||
Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (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 | NCT01413516 | |||
Other Study ID Numbers ICMJE | VIP | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Judith Prochaska, Stanford University | |||
Study Sponsor ICMJE | Stanford University | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Stanford University | |||
Verification Date | November 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |