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Digital Intervention for Smoking Cessation in Mental Illness

N/A
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or greater
Current smoker [prior to admission, smoked at least one cigarette or small cigar per day in the past month (unless restricted, e.g. due to ER/hospital visit) and smoked at least 100 cigarettes lifetime]
Must not have
Medical condition for which the use of nicotine replacement therapy (NRT) is contraindicated including pregnant, planning to become pregnant, or breastfeeding; within 4 weeks post myocardial infarction; severe arrhythmia, severe angina pectoris; peptic ulcer; severe renal failure; poorly controlled insulin-dependent diabetes; severely uncontrolled hypertension; peripheral vascular disease.
Discharge to a residential setting where smoking is prohibited
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

This trial will test whether a digital intervention can help people with serious mental illness quit smoking after they leave the hospital.

Who is the study for?
This trial is for adults over 18 with serious mental illnesses like schizophrenia, bipolar disorder, or major depression who smoke and want to quit after hospital discharge. They should be able to read, use the internet regularly post-discharge, have a mobile device with texting capability, and live within an hour of the hospital.Check my eligibility
What is being tested?
The study tests a digital smoking cessation program called BecomeAnEX designed for people with serious mental illness. It's compared against usual care methods. The goal is to help patients stay smoke-free after leaving the psychiatric hospital by using this adapted online tool.See study design
What are the potential side effects?
Since this intervention involves a digital platform rather than medication, typical drug side effects are not expected. However, participants may experience stress or frustration if they encounter difficulties using the technology or while trying to quit smoking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I currently smoke at least one cigarette a day and have smoked 100 in my lifetime.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot use nicotine replacement therapy due to a serious health condition or pregnancy.
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I will be discharged to a smoke-free home.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability
Craving
Feasibility of recruitment
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BecomeAnEXExperimental Treatment2 Interventions
Participants will have three individual meetings with a research staff person while they are in the hospital. At these meetings participants will answer questions about their smoking and interest in quitting, learn about BecomeAnEx, and register with the BecomeAnEx program so that they can use it when you leave the hospital. Participants will be given two weeks of nicotine replacement therapy when they leave the hospital. Participants will be asked to use BecomeAnEx as much as they want when they leave the hospital.
Group II: Usual CareActive Control1 Intervention
Brief individual counseling, NRT during the hospital stay and a prescription for NRT at discharge (consistent with standard hospital procedures), and referral to the MD quitline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
695 Previous Clinical Trials
376,941 Total Patients Enrolled
Sheppard Pratt Health SystemOTHER
21 Previous Clinical Trials
7,719 Total Patients Enrolled
Truth InitiativeOTHER
18 Previous Clinical Trials
29,777 Total Patients Enrolled

Media Library

Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT04367506 — N/A
Tobacco Cessation Research Study Groups: BecomeAnEX, Usual Care
Tobacco Cessation Clinical Trial 2023: Usual Care Highlights & Side Effects. Trial Name: NCT04367506 — N/A
Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04367506 — N/A
~20 spots leftby Jul 2025