Substance Use DisordersNCT05648786
Socializing a Science-Based Digital Therapeutic for Substance Use Disorders
A study testing Laddr® plus Behavioral- Group and individual counseling and Behavioral- Group and individual counseling in people with Substance Use Disorders and Substance-Related Disorders, run by Square2 Systems, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of an intervention delivered on a smartphone. This study examines whether this intervention might improve treatment outcomes for people with substance use disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Substance-Related Disorders
- What is being tested?
- Laddr® plus Behavioral- Group and individual counseling and Behavioral- Group and individual counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In first 30 days of new outpatient treatment episode at the Farnum Center
- 18 years of age or older
- Ability to provide informed consent
- Has access to a functioning smartphone
- Able to identify a support person who can participate in the study with them
- Available to participate for the full duration of the study.
Who cannot join
- Inability to understand or read English.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effectiveness of an intervention delivered on a smartphone. This study examines whether this intervention might improve treatment outcomes for people with substance use disorders. The intervention, called Laddr®, is a smartphone application ("app") that provides information and skills that can help people stop using substances. The social version of Laddr® being tested in this study has new features that allow people in treatment for substance use disorders to include a support person in their treatment journey, including a friend, family member, or other acquaintance. This research study will compare the effectiveness of Laddr® in combination with standard outpatient substance use treatment to standard treatment only for substance use disorders.
Read the detailed description
Digital therapeutics, or software used to prevent, treat, or manage a medical disorder or disease, are redefining the future of healthcare by providing on-demand access to state-of-the-science care. Digital therapeutics have been developed to treat a wide range of disorders, including substance use disorders (SUD). Developed by the study Principal Investigator (PI) and Co-Investigator (Co-I), Laddr® is a unique mobile platform integrating science-based therapeutic processes to address a wide range of behavioral problems, including SUD.
The current project expands Laddr® to allow users to engage a support network of their choosing in their journey of behavioral change. Individuals can share data from Laddr about their successes and challenges, and their support network can offer anytime/anywhere social support. Social support will be embedded within a strongly science-based digital therapeutic process - thus providing support persons with a clear framework in which to offer support. Research has shown that engaging a support network of non-substance users (e.g., family members, friends) in one's SUD treatment can greatly enhance treatment outcomes - and is aligned with the "community reinforcement" tenet of the CRA treatment model. Interventions that leverage social support networks can help keep individuals engaged in treatment, reinforce their successes, and help them troubleshoot challenges.
This pragmatic, randomized controlled trial aims to evaluate the effectiveness of the social version of Laddr® in improving SUD treatment outcomes. Adults entering outpatient SUD treatment at the Farnum Center in Manchester, New Hampshire (NH) will be offered the opportunity to be randomized to 12 weeks of standard treatment (treatment as usual [TAU] arm), or standard treatment plus the social version of Laddr® (Laddr® arm). The primary study outcome is retention in SUD treatment (time to treatment dropout), and the investigators hypothesize that participants receiving Laddr® will be retained in treatment for a longer duration. Secondary outcomes include participant substance use (self-report and urine toxicology), stages of change, coping skills, recovery capital, and treatment acceptability.
- Being tested
- Laddr® plus Behavioral- Group and individual counseling, Behavioral- Group and individual counseling
- Keywords
- Digital therapeutic, Smartphone, Social support, Randomized controlled trial
- 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.
Laddr® plus Behavioral- Group and individual counselingBehavioural
Smartphone application utilizing the Community Reinforcement Approach (CRA) to facilitate social support in substance use treatment.
Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.
Behavioral- Group and individual counselingBehavioural
The active control condition consists of standard outpatient treatment for substance use disorders. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.
| Study group | Role | What they receive |
|---|---|---|
| Standard outpatient treatment plus Laddr® | Experimental | Laddr® is a smartphone application integrating science-based, therapeutic processes to address a wide range of behavioral problems in the context of a single mobile platform. Laddr includes tools for activating behavior change, solving problems and overcoming obstacles to effective behavior change; teaching skills and providing guidance on the execution of behavior change; and maintaining the end user's motivation to change. It enables longitudinal assessment of individuals' behavior and health status in naturalistic contexts, offers science-based self-regulation behavior change tools of relevance to an array of populations, and enables ongoing monitoring of health behavior. This study evaluates the effectiveness of new features to Laddr®. These new features are designed to be used with a support person, which could include a friend, family member, or acquaintance.
In addition to Laddr®, participants will receive standard outpatient substance use disorder treatment. Receives: Behavioral: Laddr® plus Behavioral- Group and individual counseling |
| Standard outpatient treatment | Active comparator | The active control condition consists of standard outpatient treatment for substance use disorders. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services. Receives: Behavioral: Behavioral- Group and individual counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment Retention in treatment Retention in treatment Retention in treatment Retention in treatment
Time between randomization and dropout from standard outpatient treatment
Measured: 16 weeks
Secondary outcomes (5)
Substance use composite measure (Timeline Follow-Back and Urine Toxicology)
Abstinence from substance use. Each half-week of treatment will be categorized as abstinent if the toxicology screen is negative and the self-report indicates no drug use/heavy drinking days. If self-report is missing but the urine screen is positive, the half-week will be scored as not abstinent.
Measured: 16 weeks
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
Motivation to change substance use. SOCRATES scores are calculated for three domains of change readiness, Recognition (Range: 7-35), Ambivalence (Range: 4-20), and Taking Steps (Range: 8-40), with higher scores indicating higher levels of change readiness.
Measured: 16 weeks
Coping Strategies Scale (CSS)
Assessment of strategies to refuse drugs, solve problems, avoid high risk situations, cope with cravings, manage emotions, and develop assertiveness. The CSS total score is calculated by taking the mean of all items and will range from 1-4 points, with higher scores indicating more frequent use of coping strategies.
Measured: 16 weeks
Assessment of Recovery Capital (ARC)
Assessment of resources to help in recovery. This 50 item assessment is scored by assigning one point for each "Yes" response. Total scores range from 0-50 with higher scores indicating higher recovery capital.
Measured: 16 weeks
Treatment acceptability
Acceptability of the treatment model will be assessed among both patients in SUD treatment (for both treatment conditions) and support persons in the Laddr condition. Acceptability will be comprised of both utility and satisfaction with each treatment model across five indicators (0-10 point scales) asking how useful (not at all to very), how much new information (none to a great deal), how easy to understand (very easy to very difficult; reverse coded), how interesting (not at all to very), and how satisfied (not at all to very) they were with the treatment condition to which they were exposed.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start9 Nov 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 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
- NCT05648786
- Sponsor's protocol ID
- 2R44DA047150
- Other IDs
- 2R44DA047150
- Status last verified
- Nov 2024
- First submitted
- 5 Dec 2022
- Last updated
- 6 Jan 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socializing a Science-Based Digital Therapeutic for Substance Use Disorders
- ClinicalTrials.gov ID
- NCT05648786
- Acronym / sponsor ID
- 2R44DA047150
- Keywords
- Digital therapeutic, Smartphone, Social support, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Square2 Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Dec 2022 (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.
The purpose of this study is to evaluate the effectiveness of an intervention delivered on a smartphone. This study examines whether this intervention might improve treatment outcomes for people with substance use disorders. The intervention, called Laddr®, is a smartphone application ("app") that provides information and skills that can help people stop using substances. The social version of Laddr® being tested in this study has new features that allow people in treatment for substance use disorders to include a support person in their treatment journey, including a friend, family member, or other acquaintance. This research study will compare the effectiveness of Laddr® in combination with standard outpatient substance use treatment to standard treatment only for substance use disorders.
Detailed description
Digital therapeutics, or software used to prevent, treat, or manage a medical disorder or disease, are redefining the future of healthcare by providing on-demand access to state-of-the-science care. Digital therapeutics have been developed to treat a wide range of disorders, including substance use disorders (SUD). Developed by the study Principal Investigator (PI) and Co-Investigator (Co-I), Laddr® is a unique mobile platform integrating science-based therapeutic processes to address a wide range of behavioral problems, including SUD.
The current project expands Laddr® to allow users to engage a support network of their choosing in their journey of behavioral change. Individuals can share data from Laddr about their successes and challenges, and their support network can offer anytime/anywhere social support. Social support will be embedded within a strongly science-based digital therapeutic process - thus providing support persons with a clear framework in which to offer support. Research has shown that engaging a support network of non-substance users (e.g., family members, friends) in one's SUD treatment can greatly enhance treatment outcomes - and is aligned with the "community reinforcement" tenet of the CRA treatment model. Interventions that leverage social support networks can help keep individuals engaged in treatment, reinforce their successes, and help them troubleshoot challenges.
This pragmatic, randomized controlled trial aims to evaluate the effectiveness of the social version of Laddr® in improving SUD treatment outcomes. Adults entering outpatient SUD treatment at the Farnum Center in Manchester, New Hampshire (NH) will be offered the opportunity to be randomized to 12 weeks of standard treatment (treatment as usual [TAU] arm), or standard treatment plus the social version of Laddr® (Laddr® arm). The primary study outcome is retention in SUD treatment (time to treatment dropout), and the investigators hypothesize that participants receiving Laddr® will be retained in treatment for a longer duration. Secondary outcomes include participant substance use (self-report and urine toxicology), stages of change, coping skills, recovery capital, and treatment acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard outpatient treatment plus Laddr® | Experimental | Behavioral: Laddr® plus Behavioral- Group and individual counselingLaddr® is a smartphone application integrating science-based, therapeutic processes to address a wide range of behavioral problems in the context of a single mobile platform. Laddr includes tools for activating behavior change, solving problems and overcoming obstacles to effective behavior change; teaching skills and providing guidance on the execution of behavior change; and maintaining the end user's motivation to change. It enables longitudinal assessment of individuals' behavior and health status in naturalistic contexts, offers science-based self-regulation behavior change tools of relevance to an array of populations, and enables ongoing monitoring of health behavior. This study evaluates the effectiveness of new features to Laddr®. These new features are designed to be used with a support person, which could include a friend, family member, or acquaintance. In addition to Laddr®, participants will receive standard outpatient substance use disorder treatment. |
| Standard outpatient treatment | Active comparator | Behavioral: Behavioral- Group and individual counselingThe active control condition consists of standard outpatient treatment for substance use disorders. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In first 30 days of new outpatient treatment episode at the Farnum Center
- 18 years of age or older
- Ability to provide informed consent
- Has access to a functioning smartphone
- Able to identify a support person who can participate in the study with them
Key exclusion criteria (1 listed)
- Inability to understand or read English.
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 |
|---|---|---|
| Laddr® plus Behavioral- Group and individual counselingSmartphone application utilizing the Community Reinforcement Approach (CRA) to facilitate social support in substance use treatment. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services. | Behavioural | Standard outpatient treatment plus Laddr® |
| Behavioral- Group and individual counselingThe active control condition consists of standard outpatient treatment for substance use disorders. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services. | Behavioural | Standard outpatient treatment |
Primary outcome
Retention in treatment Retention in treatment Retention in treatment Retention in treatment Retention in treatment
Time frame: 16 weeks
Time between randomization and dropout from standard outpatient treatment
5 secondary outcomes
Substance use composite measure (Timeline Follow-Back and Urine Toxicology)
Time frame: 16 weeks
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
Time frame: 16 weeks
Coping Strategies Scale (CSS)
Time frame: 16 weeks
Assessment of Recovery Capital (ARC)
Time frame: 16 weeks
Treatment acceptability
Time frame: 16 weeks
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 6 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laddr® plus Behavioral- Group and individual counseling and Behavioral- Group and individual counseling in people with Substance Use Disorders and Substance-Related Disorders, 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 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 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?
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?
Retention in treatment Retention in treatment Retention in treatment Retention in treatment Retention in treatment (time frame: 16 weeks). 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 6 Jan 2025.