Varenicline In-Patient Study (VIP)
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Purpose
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). The sample, 40 women and 40 men, 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.
At the study end, the investigators will provide a letter to the study participant for his/her outpatient primary care provider that details their current smoking status and provides information on cessation medication options, including varenicline. It will be up to the primary care provider to manage the patients' treatment of tobacco dependence following study close. Of note, two-thirds of health insurance plans now cover the cost of varenicline so the cost to participants is likely to be minimal. Since participants will be recruited from Moffitt-Long, the investigators anticipate nearly all will have an appointment to see their primary care physician 4 to 5 weeks post-hospital discharge. Additionally, the investigators will refer participants to the state's toll-free quitline, whereby patients on Medi-Cal can obtain free cessation medication, and will refer any patients without insurance to the free cessation clinic at SFGH.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking Cessation |
Behavioral: Smoking counseling Drug: Placebo Drug: Varenicline |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization |
- Quit rate (those who have quit smoking and have not smoked in the 7 days prior to the assessment date) for those in the varenicline group versus the placebo group [ Time Frame: 4 weeks after beginning study ] [ Designated as safety issue: No ]
- Number of participants who report fewer smoking withdrawal symptoms and urges [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Medication compliance rate [ Time Frame: 4 weeks after initial assessment ] [ Designated as safety issue: No ]This will be measured using two biomarkers collected from blood, urine, and saliva samples.
- Time to first cigarette in experimental group versus placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Stage of change (determined by Prochaska and diClimente's model) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Number of reported adverse events for those in the varenicline group versus the placebo group [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Adverse effects assessed by structured checklist with choices of not present, mild, moderate, severe graded by FDA toxicity criteria.
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2011 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Sugar pill without any active medication
Smoking counseling, Placebo: Placebo comparator Interventions:
|
Behavioral: Smoking counseling
Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study
Drug: Placebo
Sugar pill without any active medication
Other Name: sugar pill (control)
|
|
Active Comparator: Experimental: Varenicline
Smoking counseling, Varenicline: Experimental Interventions:
|
Behavioral: Smoking counseling
Counseling sessions provided by trained smoking counselor along with varenicline
Drug: Varenicline
Varenicline (an approved medication for smoking cessation)
Other Name: Chantix
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- The sample, 40 women and 40 men, will be hospitalized patients recruited from the two medicine units (14L and 14MSHA), 10LS CVLT, and 12L Spine/Ortho at an academic medical center (Moffit Long Hospital) 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.
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; 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.
Contacts and Locations| Contact: Van Vu | 415-476-7696 |
| United States, California | |
| Moffit Long Hospital Univerisity of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Van Vu 415-476-7696 | |
| Principal Investigator: Judith Prochaska, PhD, MPH | |
More Information
No publications provided
| Responsible Party: | Jodi Prochaska, Associate Professor in Residence, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01413516 History of Changes |
| Other Study ID Numbers: | VIP |
| Study First Received: | August 3, 2011 |
| Last Updated: | May 15, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Varenicline Placebo In-Patient |
Additional relevant MeSH terms:
|
Smoking Habits Varenicline Nicotinic Agonists Cholinergic Agonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013