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Treating Smokers With Mental Illness

Primary Purpose

Smoking Cessation, Cigarette Smoking, Schizophrenia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nicotine patch

Nicotine lozenge

Therapy

Information

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring mental illness, tobacco treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

7-Day Point Prevalence Abstinence

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

Quit Attempts

To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.

Smoking Reduction

To determine the mean reduction in cigarettes per day in the intervention and control conditions.

Full Information

NCT ID

NCT03822416

First Posted

January 28, 2019

Last Updated

May 3, 2021

Sponsor

University of Minnesota

Collaborators

Hennepin County Medical Center, Minneapolis, Brown University

1. Study Identification

Unique Protocol Identification Number

NCT03822416

Brief Title

Treating Smokers With Mental Illness

Official Title

Treating Tobacco Dependence in Smokers With Severe Mental Illness

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

May 4, 2020 (Actual)

Study Completion Date

May 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

Collaborators

Hennepin County Medical Center, Minneapolis, Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

mental illness, tobacco treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nicotine patch

Intervention Description

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

Intervention Name(s)

Nicotine lozenge

Intervention Description

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

Behavioral

Intervention Name(s)

Therapy

Intervention Description

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

Other

Intervention Name(s)

Information

Intervention Description

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

Primary Outcome Measure Information:

Title

7-Day Point Prevalence Abstinence

Description

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.

Time Frame

8 weeks and 6 months post baseline

Secondary Outcome Measure Information:

Title

Quit Attempts

Description

To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.

Time Frame

8 weeks and 6 months post baseline

Title

Smoking Reduction

Description

To determine the mean reduction in cigarettes per day in the intervention and control conditions.

Time Frame

8 weeks and 6 months post baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harry Lando, PhD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33593332

Citation

Busch AM, Nederhoff DM, Dunsiger SI, Japuntich SJ, Chrastek M, Adkins-Hempel M, Rinehart LM, Lando H. Chronic care treatment for smoking cessation in patients with serious mental illness: a pilot randomized trial. BMC Psychiatry. 2021 Feb 17;21(1):104. doi: 10.1186/s12888-021-03113-5.

Results Reference

derived

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Treating Smokers With Mental Illness

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