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

NCT05266716 | Completed

• 1 other identifier: Methamphetamine Field Study
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Participant retention in treatment

  Consistent with general approaches to measure retention (Hser et al., 2004, McLellan et al., 2006), the outcome will be based on completion as a binary measure at the end of the planned 8-week intervention for each participant. At the end-of-program telephone interview, participants will be deemed to be either treatment completers (i.e., retained) or dropouts (not retained if out of program before the end of week 4). Termination, expulsion, or unexplained non-response to or no contact with Affect personnel for more than seven consecutive days in any period of the 8-week study period equates to "drop-out" for the purpose of determining retention.

  Up to 8 weeks through the duration of treatment

• Participant participation in program

  The nature/degree of participation in this study is a construct composed of the number of successfully "attended" therapeutic tasks/events/activities per the Affect app relative to not-attended events such as: scheduled/planned digital/virtual interactions for program activities (e.g., counseling, group meetings), completed biological assessments (remote drug saliva tests), and kept appointments with referred service providers (e.g., psychiatrists, physicians).

  Up to 8 weeks through the duration of treatment

• Participant engagement with the Affect app

  Engagement with the Affect app components will be assessed via app-derived data on activity (i.e., duration, frequency, and consistency of involvement with app-directed tasks).

  Up to 8 weeks through the duration of treatment

• Participant satisfaction with the Affect app

  The investigators will assess the results of surveys/questionnaires/focus groups to characterize participant satisfaction with the app and importance of its features in the overall treatment program.

  Up to 8 weeks through the duration of treatment

• Effectiveness in reducing meth use

  The effectiveness measure is a composite of self-reported meth use (daily Yes/No) and meth-negative saliva test results (conducted remotely) over the course of each participant's 8-week duration in the program. A participant who provides at least 6 of 8 meth-negative saliva tests during the final 4 weeks of the 8-week program meets criteria for reduction/cessation of meth and thus demonstrates within-participant effectiveness of the program. Characteristics of the participants will be explored for possible associated factors that correlate with variations in outcomes across the sample.

  Up to 8 weeks through the duration of treatment

Study Arms (1)

Primary Arm

EXPERIMENTAL

The study will involve a total of approximately 48 individuals enrolled during a six-week period as participants in the field test of the Affect digital therapeutic platform

Behavioral: Affect Methamphetamine Treatment Program

Interventions

Affect Methamphetamine Treatment Program BEHAVIORAL

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.

Primary Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Individuals will be precluded from enrolling in the study if they endorse (or if there is documentation of) any of following conditions. Already enrolled participants will be withdrawn from study participation upon emergence of any excluded condition (except pregnancy):
• Serious medical diagnoses (e.g., seizure, stroke, heart disease);
• Serious mental illness (e.g., schizophrenia, bipolar, active suicidality);
• Moderate- to severe-level opioid use disorder or alcohol use disorder;
• Pregnancy;
• Have been in a prior study of pharmacological or behavioral treatment for MUD within 6 months of study consent;
• Be concurrently receiving other behavioral or pharmacological services for treatment of MUD;
• Have pending legal action or other situation that could inhibit consistent participation in the study or in study activities.

Sponsors & Collaborators

• Affect Therapeutics, Inc.: lead

Study Sites (1)

Affect Therapeutics

New York, New York, 10012, United States

Location

Study Officials

• Michael Zito, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: March 4, 2022
• Study Start: February 18, 2021
• Primary Completion: June 30, 2021
• Study Completion: January 7, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)