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

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.

Study Overview

• Status: Completed
• Conditions: Methamphetamine Abuse
• Intervention / Treatment: Behavioral: Affect Methamphetamine Treatment Program

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10012
      • Affect Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

To be eligible to participate in the study, prospective participants must:

1. Be 18 years of age or older;
2. Have methamphetamine use disorder (MUD) or documented high-risk methamphetamine use history, confirmed by DSM-5 criteria for stimulant use disorder, methamphetamine type;
3. Have stated interest in reducing and/or stopping methamphetamine use;
4. Have and be able to use a smartphone and agree to download and use the Affect app as part of treatment and study-related procedures;
5. Have a health insurance plan (or Medicaid) to ensure that participants have access to medical care if needed;
6. Be English speaking and have reading capacity sufficient to understand explanations of study procedures and the informed consent to participate;
7. Be a California resident with a mailing address or P.O. Box
8. Be able to freely give informed consent and be willing to electronically sign the digital informed consent to participate in the study;
9. Be willing to comply with study procedures, including use of the Affect app consistent with the study protocol and therapeutic activities.

III.6 EXCLUSION CRITERIA

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):

1. Serious medical diagnoses (e.g., seizure, stroke, heart disease);
2. Serious mental illness (e.g., schizophrenia, bipolar, active suicidality);
3. Moderate- to severe-level opioid use disorder or alcohol use disorder;
4. Pregnancy;
5. Have been in a prior study of pharmacological or behavioral treatment for MUD within 6 months of study consent;
6. Be concurrently receiving other behavioral or pharmacological services for treatment of MUD;
7. Have pending legal action or other situation that could inhibit consistent participation in the study or in study activities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Primary Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Affect Therapeutics, Inc.
• Investigators: Principal Investigator: Michael Zito, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): January 7, 2022

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: Methamphetamine Field Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No participant data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No