Status:
COMPLETED
Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Veterans Medical Research Foundation
University of California
Conditions:
Bipolar Disorder
Schizophrenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 wit...
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 stan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2022
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04011280
Start Date
August 12 2019
End Date
March 4 2022
Last Update
June 22 2023
Active Locations (1)
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1
Pacific Treatment & Research Center at UCSD
La Jolla, California, United States, 92093