Treating Smokers With Mental Illness

May 3, 2021 updated by: University of Minnesota

Treating Tobacco Dependence in Smokers With Severe Mental Illness

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
Drug: 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
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
Behavioral: 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
Other: Information
Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community
Other: Control
Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.
Other: Information
Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-Day Point Prevalence Abstinence
Time Frame: 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.
8 weeks and 6 months post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quit Attempts
Time Frame: 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.
8 weeks and 6 months post baseline
Smoking Reduction
Time Frame: 8 weeks and 6 months post baseline
To determine the mean reduction in cigarettes per day in the intervention and control conditions.
8 weeks and 6 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Brown University
Hennepin County Medical Center, Minneapolis

Investigators

  • Principal Investigator: Harry Lando, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

May 4, 2020

Study Completion (Actual)

May 4, 2020

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPH-2018-26854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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