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Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

Primary Purpose

Bipolar Disorder, Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring nicotine, varenicline, Acceptance and Commitment Therapy, schizophrenia, schizoaffective, bipolar, smoking cessation, cigarette

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pacific Treatment & Research Center at UCSD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Dose Varenicline

Standard Dose Varenicline

Arm Description

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

1.0 mg twice daily with standard titration

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
June 25, 2019
Last Updated
June 14, 2023
Sponsor
University of California, San Diego
Collaborators
Veterans Medical Research Foundation, University of California
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1. Study Identification

Unique Protocol Identification Number
NCT04011280
Brief Title
Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness
Official Title
Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Veterans Medical Research Foundation, University of California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Nicotine Dependence
Keywords
nicotine, varenicline, Acceptance and Commitment Therapy, schizophrenia, schizoaffective, bipolar, smoking cessation, cigarette

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Everyone, with the exception of the study pharmacist, will be blinded to which arm participants will be randomized into.
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Varenicline
Arm Type
Experimental
Arm Description
0.5 mg twice daily with 0.5 mg daily titration over one full week
Arm Title
Standard Dose Varenicline
Arm Type
Active Comparator
Arm Description
1.0 mg twice daily with standard titration
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Primary Outcome Measure Information:
Title
Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies
Description
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)
Time Frame
Through completion of study, an average of 2 years
Other Pre-specified Outcome Measures:
Title
Nicotine Metabolite Ratio (NMR) Exploratory Aim
Description
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.
Time Frame
Through completion of study, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pacific Treatment & Research Center at UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

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