Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness
Status:
Recruiting
Trial end date:
2023-03-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of California, San Diego
Collaborators:
University of California Veterans Medical Research Foundation