Phase 4
Completed N=203
A Study of Varenicline for Prevention of Relapse to Smoking in Patients With Schizophrenia or Bipolar Disorder
Source: ClinicalTrials.gov NCT00621777 ↗Enrolled (actual)
203
Serious AEs
4.8%
Results posted
May 2015
Primary outcomePrimary: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group — 24; 9; 18; 7 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group |
24; 9; 18; 7; 12; 5 | — |
| SECONDARY Safety and Tolerability of Extended Duration Pharmacotherapy When Added to Antipsychotic Medications in Schizophrenia Patients Who Have Recently Quit Smoking as Assessed by the Brief Psychiatric Rating Scale |
50.43; 47.88 | — |
| SECONDARY Effect of Treatment With Varenicline Versus Placebo on Health-related Quality of Life Indices in Recently Abstinent Smokers With Schizophrenia or Bipolar Disorder as Measured by the 12-Item Short Form Health Survey (SF-12) |
47.59; 48.39 | — |
Eligibility Criteria
Inclusion Criteria
- Women and men aged 18-70
- DSM-IV diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder by diagnostic interview and chart review
- Smoke at least 10 cigarettes per day
- Clinically stable, on a stable dose of antipsychotic (schizophrenia) or mood stabilizer (bipolar) medication for at least 1 month
- No current active suicidal ideation
- Expired air carbon monoxide (CO) concentration >9 ppm
- Willing to take study medications and set a quit date within 2-3 weeks of beginning treatment and be willing to participate in the relapse prevention and follow-up portions of the study
- Women of childbearing potential must have a negative urine pregnancy test at baseline and agree to use an approved form of contraception during the study.
Exclusion Criteria
- DSM-IV diagnosis of dementia, neurodegenerative disease, or other organic mental disorder
- Substance use disorder other than nicotine or caffeine in the last 6 months
- Major depressive disorder within the last 6 months
- Serious unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 2 months
- Life-threatening arrhythmia or cerebro-vascular event within 6 months, cardiovascular event within 2 months or uncontrolled hypertension
- History of multiple head injuries with neurological sequelae, a single severe head injury with lasting neurological sequelae, or current CNS tumor
- Liver function tests elevated over twice normal
- Renal insufficiency with estimated creatinine clearance <40 ml/min
- Plan to continue use of tobacco products othe than cigarettes (e.g., cigar, pipe)
- Use of an investigational medication or device in the past 30 days
- Current suicidal or homicidal ideation
Data sourced from ClinicalTrials.gov (NCT00621777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.