Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

Schizophrenia Clinical Trial

Official title:

Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011280
• Other study ID #: 180785
• Status: Completed
• Phase: Phase 4
• Start date: August 12, 2019
• Est. completion date: March 4, 2022

Study information

• Verified date: June 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Mental Disorders
• Nicotine Dependence
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Tobacco Use Disorder

Intervention

Drug:
• Varenicline
The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.

Locations

Country	Name	City	State
United States	Pacific Treatment & Research Center at UCSD	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	University of California, Veterans Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nicotine Metabolite Ratio (NMR) Exploratory Aim	The nicotine metabolite ratio (NMR) as measured by the ratio of 3'-hydroxycotinine (the breakdown product of cotinine) divided by the concentration of cotinine (the breakdown product of nicotine) in a smoker's serum is a biomarker of nicotine clearance. Other researchers have found that a person's NMR might influence one's response to certain smoking cessation medications. The NMR was measured in serum using electrospray ionization liquid chromatography tandem mass spectrometry technology.	Through completion of study, an average of 2 years
Primary	Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies	Demand for participating (# of participants recruited per month); practicality of study procedures (% participants completing study procedures); acceptability of study procedures (% participants adhering to making a quit attempt within the quit window)	Through completion of study, an average of 2 years