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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This pilot feasibility 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 Bipolar Disorder (BD) or Schizophrenia Spectrum Disorders (SSD) with a
      12-week, post-treatment follow-up. The 16 visits after screening (Weeks 0-24) include 11
      in-person (with medications dispensed at weeks 0, 2, 4, 6, 8 and 10] and 5 via telephone.
      Plasma will be obtained at baseline to measure participants' Nicotine Metabolite Ratio (NMR)
      and to identify slow versus normal nicotine metabolisers. A flexible quit date (between days
      8-35) will be employed allowing varenicline preloading to occur prior to the Target Quit
      Date. Ten sessions of Acceptance & Commitment Therapy (ACT) for smoking cessation will be
      delivered by trained counselors.
    

Intervention name(s): Varenicline
Intervention type(s): Drug
Intervention description(s): The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Other intervention name(s): Acceptance and Commitment Therapy
Intervention MeSH terms: Varenicline
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)
Primary purpose: Treatment
Keywords: nicotine; varenicline; Acceptance and Commitment Therapy; schizophrenia; schizoaffective; bipolar; smoking cessation; cigarette