Treating Smokers With Mental Illness

NCT03822416 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SPH-2018-26854
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

mental illness; tobacco treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quit Attempts

  8 weeks and 6 months post baseline

• Smoking Reduction

  8 weeks and 6 months post baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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

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

Control

OTHER

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

Other: Information

Interventions

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

Intervention

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

Intervention

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

Intervention

Information OTHER

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Hennepin County Medical Center, Minneapolis: collaborator
• Brown University: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Busch AM, Nederhoff DM, Dunsiger SI, Japuntich SJ, Chrastek M, Adkins-Hempel M, Rinehart LM, Lando H. Chronic care treatment for smoking cessation in patients with serious mental illness: a pilot randomized trial. BMC Psychiatry. 2021 Feb 17;21(1):104. doi: 10.1186/s12888-021-03113-5.

  PMID: 33593332 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Cigarette Smoking; Schizophrenia; Psychotic Disorders; Depressive Disorder, Major; Bipolar Disorder; Mental Disorders

Interventions

Tobacco Use Cessation Devices; Therapeutics

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Smoking; Tobacco Use; Schizophrenia Spectrum and Other Psychotic Disorders; Depressive Disorder; Mood Disorders; Bipolar and Related Disorders

Results Point of Contact

• Title: Harry Lando, PhD
• Organization: University of Minnesota

lando001@umn.edu

612-624-1877

Study Officials

• Harry Lando, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will not be made aware of the participant's study status, although it may become obvious during the assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: March 1, 2019
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: May 25, 2021
• Results First Posted: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)