Smoking CessationNCT05031416
Developing and Pilot Testing a Remote Smoking Cessation Digital Therapeutic for Individuals With Serious Mental Illness
A study testing LTQ in people with Smoking Cessation, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- LTQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women who report being pregnant or have the intention to become pregnant in the 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
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.
Read the 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
- Being tested
- LTQ
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTQCombination 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
| Study group | Role | What they receive |
|---|---|---|
| Consumers who smoke at outpatient community mental health clinic | Experimental | 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 Receives: Combination Product: LTQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self reported social support
An adapted version of Online Social Support (OSS) scale for smokers will be used to evaluate self-reported social support from online smoking cessation treatment (LTQapp + Facebook group) The OSS scale is a 14 item scale with choices - 1 disagree a lot, to 4 agree a lot. Scale range 14- 56 with higher score indicating better outcome.
Measured: 13 weeks
App Usability
The System Usability Scale (SUS) is a 10-item scale used to evaluate usability of the LTQ-Connect app. Choices range from 1 strongly disagree, to 5 Strongly agree. Scale range 10-50 with higher score indicating more agreement.
Measured: 13 weeks
Number of user Interactions with the Learn to Quit (LTQ) app
Google Analytics will be used to extract number of daily app interactions and duration of engagement with LTQ app.
Measured: 13 weeks
Duration of user Interactions with the Learn to Quit (LTQ) app
Google Analytics will be used to extract daily duration of interactions with LTQ app in minutes.
Measured: 13 weeks
User Engagement with Facebook groups - Posts
The Facebook API will be used to extract number of Facebook posts.
Measured: 13 weeks
User Engagement with Facebook groups - Comments
The Facebook application programming interface (API) will be used to extract number of Facebook comments.
Measured: 13 weeks
User Engagement with Facebook groups - Likes
The Facebook API will be used to extract number of Facebook likes.
Measured: 13 weeks
User Engagement with Facebook groups - Content
The Facebook API will be used to extract engagement content of Facebook posts, comments, and 'likes.'
Measured: 13 weeks
Secondary outcomes (2)
Change in number of cigarettes smoked per day
The Smoking timeline follow-back (TLFB) will be used to estimate the number of cigarettes per day
Measured: Week 5, Week 9, and Week 13
Psychiatric Functioning
The Brief Symptom Inventory (BSI) assesses distress participants are experiencing. The BSI is a 13 item scale with choices 0=not at all, to 4= Extremely. A higher score indicates more distress. Score range 0-52.
Measured: Week 5, Week 9, and Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study startJun 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Decided not to proceed with the study at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gail Daumit, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031416
- Sponsor's protocol ID
- IRB00273925
- Other IDs
- P50MH115842
- Status last verified
- Apr 2025
- First submitted
- 12 Aug 2021
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Pilot Testing a Remote Smoking Cessation Digital Therapeutic for Individuals With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT05031416
- Acronym / sponsor ID
- IRB00273925
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decided not to proceed with the study at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consumers who smoke at outpatient community mental health clinic | Experimental | Combination Product: LTQConsumers 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Women who report being pregnant or have the intention to become pregnant in the 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTQThe 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 | Combination product | Consumers who smoke at outpatient community mental health clinic |
Primary outcome
Change in Self reported social support
Time frame: 13 weeks
An adapted version of Online Social Support (OSS) scale for smokers will be used to evaluate self-reported social support from online smoking cessation treatment (LTQapp + Facebook group) The OSS scale is a 14 item scale with choices - 1 disagree a lot, to 4 agree a lot. Scale range 14- 56 with higher score indicating better outcome.
App Usability
Time frame: 13 weeks
The System Usability Scale (SUS) is a 10-item scale used to evaluate usability of the LTQ-Connect app. Choices range from 1 strongly disagree, to 5 Strongly agree. Scale range 10-50 with higher score indicating more agreement.
Number of user Interactions with the Learn to Quit (LTQ) app
Time frame: 13 weeks
Google Analytics will be used to extract number of daily app interactions and duration of engagement with LTQ app.
Duration of user Interactions with the Learn to Quit (LTQ) app
Time frame: 13 weeks
Google Analytics will be used to extract daily duration of interactions with LTQ app in minutes.
User Engagement with Facebook groups - Posts
Time frame: 13 weeks
The Facebook API will be used to extract number of Facebook posts.
User Engagement with Facebook groups - Comments
Time frame: 13 weeks
The Facebook application programming interface (API) will be used to extract number of Facebook comments.
User Engagement with Facebook groups - Likes
Time frame: 13 weeks
The Facebook API will be used to extract number of Facebook likes.
User Engagement with Facebook groups - Content
Time frame: 13 weeks
The Facebook API will be used to extract engagement content of Facebook posts, comments, and 'likes.'
2 secondary outcomes
Change in number of cigarettes smoked per day
Time frame: Week 5, Week 9, and Week 13
Psychiatric Functioning
Time frame: Week 5, Week 9, and Week 13
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Daumit principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTQ in people with Smoking Cessation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self reported social support (time frame: 13 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.