Treating Smokers With Mental Illness

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-05-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smoking Cessation Cigarette Smoking Schizophrenia Psychotic Disorders Major Depressive Disorder Bipolar Disorder I Bipolar II Disorder Mental Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcomes assessor will not be made aware of the participant's study status, although it may become obvious during the assessments.

Study Groups

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Intervention

Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use

Nicotine lozenge

Intervention Type DRUG

Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use

Therapy

Intervention Type BEHAVIORAL

In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase

Information

Intervention Type OTHER

Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community

Control

Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.

Group Type OTHER

Information

Intervention Type OTHER

Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community

Interventions

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Nicotine patch

Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use

Intervention Type DRUG

Nicotine lozenge

Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use

Intervention Type DRUG

Therapy

In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase

Intervention Type BEHAVIORAL

Information

Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community

Intervention Type OTHER

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes