Treating Smokers With Mental Illness

Phase 2

Completed

• Conditions: Schizophrenia; Cigarette Smoking; Bipolar Disorder I; Psychotic Disorders; Mental Illness; Smoking Cessation; Major Depressive Disorder; Bipolar II Disorder
• Interventions: Drug: Nicotine patch; Drug: Nicotine lozenge; Behavioral: Therapy; Other: Information

• Registration Number: NCT03822416
• Lead Sponsor: University of Minnesota

Brief Summary

This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.

Detailed Description

At the baseline measurement visit, participants will be asked to complete a survey and an interview. They will be randomly assigned to either the intervention or control group. Both groups will receive a smoking cessation manual and list of resources. The intervention group will also receive smoking cessation counseling and nicotine replacement therapy. Both groups will be seen for in-person assessments again at 8 weeks and 6 months post baseline.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-30
• Study Start: 2019-03-01
• Primary Completion: 2020-05-04
• Study Completion: 2020-05-04
• Status Verified: 2021-05
• Results First Submitted: 2021-05-03
• Results First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Results First Posted: 2021-05-25
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• have a severe mental illness diagnosis
• be a daily smoker
• be willing to reduce the number of cigarettes smoked per day leading to a quit attempt
• want to try to quit smoking
• be willing to use nicotine replacement therapy
• be able to communicate in English

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Exclusion Criteria

• anyone who has had an active psychotic episode or been hospitalized due to suicidal ideation in the last six months
• pregnancy
• taking Chantix or Clozapine
• having a terminal illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Nicotine patch	Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
Intervention	Nicotine lozenge	Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
Intervention	Information	Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
Control	Information	Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.
Intervention	Therapy	Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.

Primary Outcome Measures

Name	Time	Method
7-Day Point Prevalence Abstinence	8 weeks and 6 months post baseline	To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment.

Secondary Outcome Measures

Name	Time	Method
Quit Attempts	8 weeks and 6 months post baseline	To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.
Smoking Reduction	8 weeks and 6 months post baseline	To determine the mean reduction in cigarettes per day in the intervention and control conditions.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States