NCT03822416

Treating Smokers With Mental Illness

Treating Tobacco Dependence in Smokers With Severe Mental Illness

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-05-04
• Completion: 2020-05-04
• First posted: 2019-01-30
• Last updated: 2021-05-25
• Results posted: 2021-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study