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Sponsors and Collaborators: |
Massachusetts General Hospital National Institute on Drug Abuse (NIDA) |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00621777 |
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. 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.
To assess this possibility, we will evaluate the safety and efficacy of 12 months of varenicline in schizophrenia patients who are able to quit smoking in the short term with this treatment. To do so, we will enroll 274 smokers with schizophrenia from 4 mental health clinics in Massachusetts and New Hampshire 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 4 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.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder Smoking |
Drug: Varenicline Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Extended Duration Pharmacotherapy for Prevention of Relapse to Smoking |
Estimated Enrollment: | 274 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Varenicline: Active Comparator
Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year. Because varenicline, at a dose of 1 mg twice per day, may be a more effective treatment for sustained abstinence than bupropion, it was chosen as the medication intervention for this study.
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Drug: Varenicline
At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks. In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks. |
Placebo: Placebo Comparator |
Drug: Placebo
At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks. In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks. |
Participants will be moderate to heavy smokers, aged 18-70, who have smoked an average of ≥10 cigarettes/day for the past year and who have not quit during the past year for a period >1 month.
During a 12-week open phase smoking cessation program, eligible subjects will be given active varenicline in addition to a 13-session weekly cognitive behavioral therapy program for smoking cessation. Dr. Evins (Principal Investigator) or a co-investigator will meet with subjects individually at Baseline of the Smoking Cessation Program to assess their medical eligibility for varenicline. A chart review will also be conducted by a research physician or psychiatrist.
Dr. Evins or another prescribing co-investigator will write a prescription for varenicline for each medically eligible subject. Subjects will receive their study medication at the end of each weekly group meeting. Any subject who experiences a serious side effect to the medication will meet with Dr.
Evins or another medical co-investigator individually.
Subjects will set quit dates between the fourth and fifth CBT session weeks. Self-reports and exhaled carbon monoxide (CO) levels will be used to assess smoking status. Those subjects who have been abstinent for ≥2 weeks at the end of the 12th session group will be eligible for a 40-week relapse prevention program. After enrolling in the Relapse Prevention Program, subjects will be randomized to receive varenicline or placebos in addition to CBT for relapse prevention.
At Week 12 (the week before the end of the Smoking Cessation Program), Dr. Evins or another prescribing co-investigator will write prescriptions for subjects eligible for the randomized Relapse Prevention phase (i.e. successful quitters); these prescriptions will be sent to the Massachusetts General Hospital Research Pharmacy, where they will be filled according to the randomization code that the a research pharmacist will create.
When subjects come for the CBT orientation group session of the Relapse Prevention Program (Week 13), they will receive a 1-month supply of varenicline or placebo pill. During this randomized Relapse Prevention phase, medication compliance will be assessed at every group meeting by pill-count. Subjects will be asked about medication compliance and side effects at each group by the CBT group leaders and staff.
Any subject who experiences a serious side effect to the medication will meet with Dr. Evins or another medical co-investigator individually. In addition, Dr. Evins or a medical co-investigator will review the adverse events forms for each subject every week. Again, self-report and CO levels will be used to monitor smoking status.
Before and during both the open and randomized relapse prevention phases, subjects will be periodically assessed for cognitive performance, clinical characteristics, and adverse events in order to evaluate effects of withdrawal, predictors of cessation and relapse, and medication side effects.
Following the completion of the 40-week relapse prevention phase, 3 follow-up assessments will be performed over a 3-month period to evaluate smoking status, cognitive functioning, and clinical effects.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Annie R. Shawn, BA | (617) 643-4689 | ashawn@partners.org |
Contact: Max Tedaldi, BA | (617) 643-4692 | mtedaldi@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Annie Shawn, BA 617-643-4689 ashawn@partners.org | |
Contact: Max Tedaldi, BA 617 643-4692 mtedaldi@partners.org | |
Principal Investigator: A. Eden Evins, MD, MPH | |
Sub-Investigator: Corinne Cather, PhD | |
Sub-Investigator: Jennifer Gottlieb, PhD | |
Community Health Link, University of Massachusetts | Not yet recruiting |
Worcester, Massachusetts, United States, 10612 | |
Contact: Anne Fletcher, MSW 617-626-9412 a_fletcher_hopes@yahoo.com | |
Principal Investigator: Alan Birnbaum, PhD | |
Massachusetts Mental Health Center | Not yet recruiting |
Jamaica Plain, Massachusetts, United States, 02130 | |
Contact: Eileen Wong, MD 617-626-9367 eileen.wong@state.ma.us | |
United States, Michigan | |
Touchstone Innovare | Recruiting |
Grand Rapids, Michigan, United States, 49503 | |
Contact: Heather Willett, MA 616-826-6526 heather.willett@pinerest.org | |
Principal Investigator: Eric D Achtyes, MD, MS | |
Sub-Investigator: Katherine DeVries, LMSW | |
Sub-Investigator: Greg Deacon, MA | |
United States, New Hampshire | |
Community Council of Nashua | Not yet recruiting |
Nashua, New Hampshire, United States, 03063 | |
Contact: Sarah Pratt, Ph.D 603-271-5747 ext 3489 Sarah.I.Pratt@Dartmouth.edu | |
Principal Investigator: Sarah Pratt, PhD | |
Sub-Investigator: Megah McCarthy, MSW |
Principal Investigator: | A. Eden Evins, MD, MPH | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( A. Eden Evins, MD, MPH ) |
Study ID Numbers: | PHRC# 2007-P-002221 |
Study First Received: | February 12, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00621777 History of Changes |
Health Authority: | United States: Food and Drug Administration |
schizophrenia varenicline smoking cessation relapse prevention cognitive behavioral therapy |
Schizophrenia Smoking Mental Disorders |
Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Varenicline |
Schizophrenia Habits Smoking |
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |