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Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011280
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : September 17, 2020
Sponsor:
Collaborators:
Veterans Medical Research Foundation
University of California
Information provided by (Responsible Party):
Robert Anthenelli, MD, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Schizophrenia Schizoaffective Disorder Nicotine Dependence Drug: Varenicline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Everyone, with the exception of the study pharmacist, will be blinded to which arm participants will be randomized into.
Primary Purpose: Treatment
Official Title: Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose Varenicline
0.5 mg twice daily with 0.5 mg daily titration over one full week
Drug: Varenicline
The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Other Name: Acceptance and Commitment Therapy

Active Comparator: Standard Dose Varenicline
1.0 mg twice daily with standard titration
Drug: Varenicline
The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Other Name: Acceptance and Commitment Therapy




Primary Outcome Measures :
  1. Feasibility of combining ACT with 2 different varenicline-assisted quitting strategies [ Time Frame: Through completion of study, an average of 2 years ]
    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 :
  1. Explore whether nicotine metabolism influences medication tolerability [ Time Frame: Through completion of study, an average of 2 years ]
    Nicotine metabolite ratio (ratio of trans-3'-hydroxycotinine / cotinine in plasma) in relation to adverse events (volunteered, observed or solicited adverse events occurring during study treatment + 30 days). Slow nicotine metabolisers will be compared with normal nicotine metabolisers on the incidence (% who experienced) adverse events



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011280


Contacts
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Contact: Benjamin McKenna, PhD 858-534-8817 bmckenna@ucsd.edu

Locations
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United States, California
Pacific Treatment & Research Center at UCSD Recruiting
La Jolla, California, United States, 92093
Contact: Esther Wong, BA    858-246-4673    PacTarc@gmail.com   
Contact: Ben McKenna, PhD    858-246-4673      
Sponsors and Collaborators
University of California, San Diego
Veterans Medical Research Foundation
University of California
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Responsible Party: Robert Anthenelli, MD, Principal Investigator and Study Physician, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04011280    
Other Study ID Numbers: 180785
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Robert Anthenelli, MD, University of California, San Diego:
nicotine
varenicline
Acceptance and Commitment Therapy
schizophrenia
schizoaffective
bipolar
smoking cessation
cigarette
Additional relevant MeSH terms:
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Disease
Tobacco Use Disorder
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs