Substance Use Disorders (SUDs)NCT07104396
Cogito: A Turnkey Solution for Rapidly Developing, Evaluating, Deploying, and Scaling Digital Therapeutics
An observational study of Substance Use Disorders (SUDs), run by Square2 Systems, Inc. at 1 site in United States.
Trial summary
This is a research study to evaluate the usability of the Cogito digital therapeutics development platform. The Cogito platform is designed to allow researchers who are seeking to embed an evidence-based behavioral therapy into a digital delivery platform to do so via a drag and drop interface with no programming… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders (SUDs)
- What is being tested?
- Cogito digital therapeutics development platform
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The research team will recruit 20 (> 18 years) clinical researchers/clinicians to utilize Cogito to provide feedback on its usability, utility, and likability and relevance as a development and hosting platform. Participants must be PhD and/or MD-level scientists at academic institutions or digital health companies at the level of Post-doctoral Fellow or higher. Participants must be trained/training in SUD research. Participants must state a specific interest in digital therapeutics for SUDs. The researchers expect participants will have interests ranging from developing novel behavioral digital therapies for SUDs to digital therapeutics that promote adherence to SUD medications to digital therapeutics for SUDs and co-occurring conditions to digital management tools which help individuals with care transitions.
Who may be able to join
- At least 18 years
- PhD and/or MD-level (or equivalent) scientists at academic institutions or digital health companies at the level of Post-doctoral Fellow or higher.
- Training or trained in substance use disorder (SUDs) research.
- Must state a specific interest in digital therapeutics for SUDs.
Who cannot join
- Those who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Square2 Systems contact
United States1 site, 1 recruiting
- Recruiting
Square 2 Systems
Hanover, New Hampshire, 03755
Research Coordinator, (802) 526-4608
About this study
This is a research study to evaluate the usability of the Cogito digital therapeutics development platform.
The Cogito platform is designed to allow researchers who are seeking to embed an evidence-based behavioral therapy into a digital delivery platform to do so via a drag and drop interface with no programming skills necessary. It will provide the components for building a digital therapeutic for any health condition and population.
And in this initial study, the research team plans to examine the usability of Cogito in building a digital therapeutic for substance use disorders (SUDs).
Read the detailed description
Each participant will be asked to:
- Complete an interactive tutorial describing what Cogito is and how to create a sample guide, sample activities, and a sample survey.
- Explore using the various Cogito processes by completing a "functionality scavenger hunt". In this scavenger hunt, participants will be walked through a series of activities to create new guides, activities and surveys.
- Complete surveys to provide feedback on participants' experience using Cogito
- Conditions
- Substance Use Disorders (SUDs)
- Being tested
- Cogito digital therapeutics development platform
- Keywords
- digital therapeutics, substance use disorders, development platform
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogito digital therapeutics development platformOther
Cogito will provide a turnkey solution for rapidly developing, evaluating, deploying, and scaling digital therapeutics for the prevention, treatment and/or management of any disease or disorder. This platform will allow researchers who are seeking to embed an evidence-based behavioral therapy into a digital delivery platform to do so via a drag and drop interface with no programming skills necessary. It will provide all the components for building a digital therapeutic for any health condition and population. Overall, Cogito offers great promise to markedly accelerate the pace and impact of science based digital therapeutics.
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
Each participant will be asked to complete the standardized 10-item System Usability Scale (SUS) to evaluate the usability of Cogito (e.g., "I think I would like to use this system frequently"), ranging from "strongly agree" to "strongly disagree".
Measured: To be completed immediately after usability feedback session
Secondary outcomes (1)
Visual Analog Scales
100 mm Visual Analog measures, ranging from "Not at All" anchored at 0 to "Very" anchored at 100 for each question, with every question worded positively to assess how (1) easy to use, (2) understandable, (3) likable, (4) useful (5) relevant they found the Cogito development functionality in each stage of the scavenger hunt as well as (6) how likely they would be to use Cogito as a digital therapeutics development and hosting platform.
Measured: To be completed immediately after usability feedback session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start2 Jul 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorders (SUDs)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Square2 Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Grabinski, Square2 Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104396
- Sponsor's protocol ID
- 1R43DA060729-01
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cogito: A Turnkey Solution for Rapidly Developing, Evaluating, Deploying, and Scaling Digital Therapeutics
- ClinicalTrials.gov ID
- NCT07104396
- Acronym / sponsor ID
- 1R43DA060729-01
- Conditions
- Substance Use Disorders (SUDs)
- Keywords
- digital therapeutics, substance use disorders, development platform
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Square2 Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 5 Aug 2025 (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 research study to evaluate the usability of the Cogito digital therapeutics development platform.
The Cogito platform is designed to allow researchers who are seeking to embed an evidence-based behavioral therapy into a digital delivery platform to do so via a drag and drop interface with no programming skills necessary. It will provide the components for building a digital therapeutic for any health condition and population.
And in this initial study, the research team plans to examine the usability of Cogito in building a digital therapeutic for substance use disorders (SUDs).
Detailed description
Each participant will be asked to:
- Complete an interactive tutorial describing what Cogito is and how to create a sample guide, sample activities, and a sample survey.
- Explore using the various Cogito processes by completing a "functionality scavenger hunt". In this scavenger hunt, participants will be walked through a series of activities to create new guides, activities and surveys.
- Complete surveys to provide feedback on participants' experience using Cogito
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The research team will recruit 20 (> 18 years) clinical researchers/clinicians to utilize Cogito to provide feedback on its usability, utility, and likability and relevance as a development and hosting platform. Participants must be PhD and/or MD-level scientists at academic institutions or digital health companies at the level of Post-doctoral Fellow or higher. Participants must be trained/training in SUD research. Participants must state a specific interest in digital therapeutics for SUDs. The researchers expect participants will have interests ranging from developing novel behavioral digital therapies for SUDs to digital therapeutics that promote adherence to SUD medications to digital therapeutics for SUDs and co-occurring conditions to digital management tools which help individuals with care transitions.
Key inclusion criteria (4 listed)
- At least 18 years
- PhD and/or MD-level (or equivalent) scientists at academic institutions or digital health companies at the level of Post-doctoral Fellow or higher.
- Training or trained in substance use disorder (SUDs) research.
- Must state a specific interest in digital therapeutics for SUDs.
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria.
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 |
|---|---|---|
| Cogito digital therapeutics development platformCogito will provide a turnkey solution for rapidly developing, evaluating, deploying, and scaling digital therapeutics for the prevention, treatment and/or management of any disease or disorder. This platform will allow researchers who are seeking to embed an evidence-based behavioral therapy into a digital delivery platform to do so via a drag and drop interface with no programming skills necessary. It will provide all the components for building a digital therapeutic for any health condition and population. Overall, Cogito offers great promise to markedly accelerate the pace and impact of science based digital therapeutics. | Other | – |
Primary outcome
System Usability Scale
Time frame: To be completed immediately after usability feedback session
Each participant will be asked to complete the standardized 10-item System Usability Scale (SUS) to evaluate the usability of Cogito (e.g., "I think I would like to use this system frequently"), ranging from "strongly agree" to "strongly disagree".
1 secondary outcome
Visual Analog Scales
Time frame: To be completed immediately after usability feedback session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Square2 Systems contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders (SUDs), run by Square2 Systems, Inc. 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: looking for participants now, as of the sponsor's last update on 11 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Square2 Systems ((802) 526-4608), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: To be completed immediately after usability feedback session). 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 11 Aug 2025.