NCT04011280

Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder
• Schizophrenia
• Schizoaffective Disorder
• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Varenicline	The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.

Timeline

• Start date: 2019-08-12
• Primary completion: 2022-03-04
• Completion: 2022-03-04
• First posted: 2019-07-08
• Last updated: 2023-06-22
• Results posted: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study