Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness
Condition: Bipolar Disorder; Schizophrenia; Schizoaffective Disorder; Nicotine Dependence
MeSH terms: Tobacco Use Disorder; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Intervention: Varenicline
Intervention description: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This pilot trial is a Phase IV, 12-week, single center, randomized, double blind, parallel group comparison of low (0.5 mg twice daily with slower titration over one full week) versus standard dose (1.0 mg twice daily with standard titration) varenicline in individuals with DSM-V BD or SSD with a 12-week, post-treatment follow-up.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Everyone, with the exception of the study pharmacist, will be blinded to which arm participants will be randomized into.
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: nicotine; varenicline; Acceptance and Commitment Therapy; schizophrenia; schizoaffective; bipolar; smoking cessation; cigarette

Summary:

      Approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective
      disorder who are motivated to try to quit smoking will be randomized to receive smoking
      cessation treatment with the FDA-approved medication, varenicline, delivered either a) at its
      standard dose and titration schedule (half of the participants) versus b) at a lower dose and
      slower titration schedule (the other half), for 12 weeks. All smokers will choose a target
      quit date sometime between 8 to 35 days after starting the medication. All participants will
      receive ten 30-minute sessions of a behavioral treatment called Acceptance and Commitment
      Therapy (ACT). Participants will be followed for an additional 12 weeks off study medication.
      The major endpoint is the feasibility of combining ACT with the different dosing strategies.
      Investigators will also conduct a blood test that measures the breakdown of nicotine in the
      body to explore whether that measure influences treatment response and side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-70 years of age

          -  Outpatients with a DSM-V diagnosis of Bipolar Disorder or Schizophrenia Spectrum
             Disorder

          -  Smoke at least 10 cigarettes per day and have an expired carbon monoxide (CO)
             breathalyzer of ≥ 10 ppm at screening and baseline visits

          -  Are motivated to quit smoking

          -  Have access to a mental health provider

        Exclusion Criteria:

          -  Females who are pregnant, planning to become pregnant, or lactating

          -  Test positive for any non-prescribed medications or illicit drugs

          -  Have made a suicide attempt or engaged in self-mutilatory behavior in the past year

          -  Meet criteria for another Substance Use Disorder in the past month

          -  In the investigators' judgement, are either psychiatrically or medically unstable to
             safely participate

          -  Are currently using any other form of treatment for smoking cessation