NCT05266716

Field Study of a Digital Therapeutic Platform to Facilitate Treatment for Methamphetamine-Primary Stimulant Use Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Affect Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of the observational, investigational pilot study is to assess the clinical utility of the Affect digital health platform (the Affect® "app") as part of the Affect program of treatment for methamphetamine-primary stimulant use disorder. The study also will identify elements of the Affect app that enhance engagement of participants in the study toward the goal of improving patient outcomes, including reduction/cessation of stimulant use.

Detailed description

The research project is a single-group observational demonstration study to assess the clinical utility of a digital therapeutic technology (the Affect app) in terms of participant acceptance and the app's ability to enhance retention in the Affect program of services for the treatment of individuals with meth-primary stimulant use disorder (MUD). Measures of reduction and/or cessation of methamphetamine use will be assessed by saliva drug tests at least twice weekly during each participant's 8-week involvement in the program, at end of treatment, and via self-report at follow-up points at 1, 3, and 6 months after completion of the program. The app-based program will involve the same services for study participants as would occur regardless of the research, being a standard of care for MUD. The intervention phase of the study will be completed within approximately four months, with follow-ups of the final participants occurring approximately six months after the end of the intervention phase.

Conditions

• Methamphetamine Abuse

Interventions

Type	Name	Description
BEHAVIORAL	Affect Methamphetamine Treatment Program	Components of the treatment services include: contingency management (CM; monetary incentives for drug tests negative for stimulants), the digital behavioral therapy curriculum (based on CBT) delivered via the Affect app on smartphones, weekly one-on-one telemedicine (TM) with clinical personnel and group therapy, and referral to psychiatrist for medication support, as needed. The program incrementally builds skills and beliefs to develop personally meaningful strategies to combat cravings, using such techniques as regular app-promoted deep breathing exercises, daily exercise, and help in making and sticking to a relapse prevention plan. Counseling sessions are arranged via text sent by the Team Care advocate and also presented to the participant via the app as a reminder. Individual and group therapy sessions occur over Zoom, which is integrated into the app. Contingency Management (CM). CM utilizes monetary incentives and rewards to promote behavior change.

Timeline

• Start date: 2021-02-18
• Primary completion: 2021-06-30
• Completion: 2022-01-07
• First posted: 2022-03-04
• Last updated: 2022-03-04

Locations

1 site across 1 country: United States