A Study of Varenicline for Prevention of Relapse to Smoking in Patients With Schizophrenia or Bipolar Disorder
Public ClinicalTrials.gov record NCT00621777. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Extended Duration Pharmacotherapy for Prevention of Relapse to Smoking
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Varenicline (Chantix) is a smoking cessation treatment that was approved in 2006 by the FDA for treatment of nicotine dependence and may be particularly beneficial in smokers with schizophrenia or bipolar disorder. Early experience with varenicline indicates that it will be effective for smoking cessation in schizophrenia and in addition, has the potential to be therapeutic for cognitive dysfunction in this population. In addition, more data is needed to evaluate the safety, tolerability and effectiveness of Varenicline in people with bipolar disorder. To assess this possibility, we will evaluate the safety and efficacy of 12 months of varenicline in schizophrenia or bipolar disorder patients who are able to quit smoking in the short term with this treatment. To do so, we will enroll 324 smokers with schizophrenia or bipolar disorder from 6 mental health clinics in Massachusetts, New Hampshire, Michigan and Minnesota into an open, 12-week smoking cessation program that includes varenicline added to weekly group cognitive behavioral therapy (CBT). Those who achieve at least 2 weeks of continuous abstinence during the last 2 weeks of the open intervention will be randomized to the relapse prevention phase: a 40-week, double blind, placebo-controlled trial of varenicline at the dose used to quit smoking added to a tapering CBT schedule. Participants will then discontinue study medications and behavioral treatment and enter a 3-month follow up phase.
Study identification
- NCT ID
- NCT00621777
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 247 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2008
- Primary completion
- Apr 30, 2013
- Completion
- Apr 30, 2013
- Last update posted
- Dec 20, 2017
2008 – 2013
United States locations
- U.S. sites
- 10
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Psychology Clinic | Birmingham | Alabama | 35233 | — |
| Centerstone Research Institute | Bloomington | Indiana | 47401 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Massachusetts Mental Health Center | Boston | Massachusetts | 02115 | — |
| Touchstone Innovare | Grand Rapids | Michigan | 49503 | — |
| University of Minnesota Psychological Clinic | Minneapolis | Minnesota | 55454 | — |
| West Central Behavioral Health | Claremont | New Hampshire | 03743 | — |
| Riverbend Community Mental Health Center | Concord | New Hampshire | 03302 | — |
| The Mental Health Center of Greater Manchester | Manchester | New Hampshire | 03103 | — |
| Community Council of Nashua | Nashua | New Hampshire | 03063 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00621777, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 20, 2017 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00621777 live on ClinicalTrials.gov.