Treating Smokers With Mental Illness

Schizophrenia Clinical Trial

Official title:

Treating Tobacco Dependence in Smokers With Severe Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822416
• Other study ID #: SPH-2018-26854
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: May 4, 2020

Study information

• Verified date: May 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 4, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	Brown University, Hennepin County Medical Center, Minneapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks and 6 months post baseline
Secondary	Quit Attempts	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
Secondary	Smoking Reduction	To determine the mean reduction in cigarettes per day in the intervention and control conditions.	8 weeks and 6 months post baseline