Developing and Pilot Testing a Remote Smoking Cessation Digital Therapeutic for Individuals With Serious Mental Illness

NCT ID: NCT05031416

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-12-31

Brief Summary

This is a pilot randomized clinical trial testing an implementation intervention to support delivery of a smoking cessation app tailored to the needs of those individuals with SMI who at community mental health programs.

Detailed Description

Learn to Quit (LTQ), an evidence-based smoking cessation app tailored to the needs of individuals with serious mental illness (SMI) that demonstrated promising smoking cessation outcomes in a recent pilot randomized controlled trial (R00 DA037276). In parallel, several trials demonstrated that widely available social media platforms can be effectively utilized to enhance the effects of standard of care evidence-based smoking cessation treatments. Both approaches capitalize on highly scalable digital technologies, and are therefore likely to have population level impact. Drawing from these two separate programs of research, the central premise of this proposal is that LTQ, a stand-alone smoking cessation app tailored to patients with SMI, can be enhanced with peer-support delivered on social media. Therefore, this proposal seeks to develop and asses the acceptability and feasibility of LTQ-Connect -- the integration of the evidence-based smoking cessation app, LTQ, with social support delivered via social media -- to boost the efficacy and community reach of digital therapeutics tailored for patients with SMI. To achieve this goal, we will:

(1) determine the ideal design requirements of an LTQ-Connect integration among smokers with SMI, and (2) investigate the feasibility of LTQ-Connect in a single group pilot trial. Both interventions will be combined with nicotine replacement therapy, a safe and widely available medication.

Conditions

Smoking Cessation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Consumers who smoke at outpatient community mental health clinic

Consumers with serious mental illness who attend outpatient community mental health clinic will participate in a smoking cessation with the LTQ application and nicotine replacement therapy

Group Type: EXPERIMENTAL

LTQ

Intervention Type: COMBINATION_PRODUCT

The investigators will test the LTQ-Connect application and a standard 10-week course of nicotine replacement therapy (NRT) nicotine patches, and Facebook groups, which will run for a total of 3 months with research study participants

Interventions

LTQ

The investigators will test the LTQ-Connect application and a standard 10-week course of nicotine replacement therapy (NRT) nicotine patches, and Facebook groups, which will run for a total of 3 months with research study participants

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Must be a mental health consumer at Johns Hopkins Bayview Adult Psychiatry Program
• A regular smoker who is willing to quit
• Own a smart cell phone
• Willing to participate

Exclusion Criteria

• Women who report being pregnant or have the intention to become pregnant in the 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Daumit

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

P50MH115842

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00273925

Identifier Type: -

Identifier Source: org_study_id