Socializing a Science-Based Digital Therapeutic for Substance Use Disorders

Substance Use Disorders Clinical Trial

Official title:

Socializing a Science-Based Digital Therapeutic for Substance Use Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648786
• Other study ID #: 2R44DA047150
• Secondary ID: 2R44DA047150
• Status: Recruiting
• Phase: Phase 2
• Start date: November 9, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Square2 Systems, Inc.
• Contact: Lisa Marsch
• Phone: 978-300-2413
• Email: lisam[@]square2.co
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Laddr® plus Behavioral- Group and individual counseling
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 counseling
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.

Locations

Country	Name	City	State
United States	Farnum Center	Manchester	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Square2 Systems, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in treatment Retention in treatment Retention in treatment Retention in treatment Retention in treatment	Time between randomization and dropout from standard outpatient treatment	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks