Skip to main content
OpenTrials
Completed

NCT Number: NCT03822416

Treating Smokers With 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Bipolar Disorder Bipolar Disorder I Bipolar II Disorder Bipolar and Related Disorders Cigarette Smoking Depressive Disorder Depressive Disorder, Major Health Behavior Major Depressive Disorder Mental Disorders Mental Illness Mood Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Smoking Tobacco Smoking Tobacco Use

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch

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

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

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

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Brown University
  • Hennepin County Medical Center, Minneapolis

Registry information

Official study title

Treating Tobacco Dependence in Smokers With Severe Mental Illness

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2019
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.