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

NCT05266716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2022-03-04

No results posted yet for this study

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.

Conditions

  • Methamphetamine Abuse

Interventions

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.

Sponsors & Collaborators

  • Affect Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Zito, MD · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2021-06-30
Completion
2022-01-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05266716 on ClinicalTrials.gov