Clinical trial NCT05648786: Socializing a Science-Based Digital Therapeutic for Substance Use Disorders
Official title: Socializing a Science-Based Digital Therapeutic for Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Substance-Related Disorders
Keywords: Digital therapeutic
Smartphone
Social support
Randomized controlled trial
Lead sponsor: Square2 Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-12-13
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Inability to understand or read English.

Primary outcomes:
measure: Retention in treatment Retention in treatment Retention in treatment Retention in treatment Retention in treatment
timeFrame: 16 weeks
Secondary outcomes:
measure: Substance use composite measure (Timeline Follow-Back and Urine Toxicology)
timeFrame: 16 weeks
measure: Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
timeFrame: 16 weeks
measure: Coping Strategies Scale (CSS)
timeFrame: 16 weeks
measure: Assessment of Recovery Capital (ARC)
timeFrame: 16 weeks
measure: Treatment acceptability
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Manchester
country: United States
facility: Farnum Center
state: New Hampshire
Study officials:
References: