Treating Smokers With Mental Illness

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

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

Treatments: Drug: Nicotine patch; Drug: Nicotine lozenge; Behavioral: Therapy; Other: Information

Study type: Interventional

Funder types: Other

Identifiers

NCT03822416

SPH-2018-26854

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Drug: Nicotine patch

Drug: Nicotine lozenge

Other: Information

Behavioral: Therapy

Control

Other group

Description:

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

Treatment:

Other: Information