Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

NCT04011280 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 180785
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder; Schizophrenia; Schizoaffective Disorder; Nicotine Dependence

Keywords

nicotine; varenicline; Acceptance and Commitment Therapy; schizophrenia; schizoaffective; bipolar; smoking cessation; cigarette

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Nicotine Metabolite Ratio (NMR) Exploratory Aim

  Through completion of study, an average of 2 years

Study Arms (2)

Low Dose Varenicline

EXPERIMENTAL

0.5 mg twice daily with 0.5 mg daily titration over one full week

Drug: Varenicline

Standard Dose Varenicline

ACTIVE COMPARATOR

1.0 mg twice daily with standard titration

Drug: Varenicline

Interventions

Varenicline DRUG

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

Also known as: Acceptance and Commitment Therapy

Low Dose Varenicline; Standard Dose Varenicline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Veterans Medical Research Foundation: collaborator
• University of California: collaborator

Study Sites (1)

Pacific Treatment & Research Center at UCSD

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia; Psychotic Disorders; Tobacco Use Disorder; Smoking Cessation

Interventions

Varenicline; Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Benjamin McKenna
• Organization: Pacific Treatment and Research Center

bmckenna@health.ucsd.edu

858-534-8817

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Everyone, with the exception of the study pharmacist, will be blinded to which arm participants will be randomized into.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Study Physician

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 8, 2019
• Study Start: August 12, 2019
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-06

Locations

US (1)