Treating Smokers With Mental Illness

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• Hennepin County Medical Center, Minneapolis

  collaborator OTHER

• Brown University

  collaborator OTHER

• University of Minnesota

  lead OTHER

Principal Investigators

• Harry Lando, PhD · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2020-05-04

Completion

2020-05-04

FDA Drug

Yes

Countries

• United States

Study Locations