Demonstration of a Digital Care Program for Methamphetamine Use Disorder

NCT05206175 | Completed

• 2 other identifiers: Methamphetamine StudyR43DA055394
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I Small Business Innovation Research (SBIR) project will examine the technical merit and real-world feasibility of the Affect smartphone application ("app") as the core component of the Affect digital care program for treatment of methamphetamine use disorder (MUD).

Conditions

Methamphetamine Abuse

Outcome Measures

Primary Outcomes (3)

• Participation retention and completion of treatment

  Participant retention and completion of the program will be measured as consistency of participant involvement through the end of the 8-week program, with criteria for completion being data on participation in \>50% of potential therapeutic interactions and activities. A related "time in treatment" measure will also characterize retention (and detail aspects of engagement). 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 (excluding those who drop out in week 1).

  Up to 8 weeks through the duration of treatment

• Patient engagement and program adherence

  The nature/degree of participation in this study will be measured as 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 biologic tests), and kept appointments with referred service providers (e.g., psychiatrists, physicians). Engagement with the Affect app components will be assessed via app-derived data on activity (i.e., duration, frequency, consistency of involvement with app-directed tasks). We will extract use-specific data on participants' interactions with the app, as well as results of surveys/questionnaires/focus groups to characterize associations of app and program components and procedures and their impacts on patient-level outcomes (e.g., retention in the program and meth use).

  Up to 8 weeks through the duration of treatment

• Effectiveness in reducing meth use

  The effectiveness outcome is determined by demonstrated reductions of meth use measured via a composite measure of self-reported meth use (daily Yes/No) plus results of biologic screens to provide indication of effectiveness. The criterion measure of clinically meaningful reduction of meth use will be 4 meth-negative biologic screens of the 8 possible biologic screens during the final 4 weeks of the 8-week program (concurring with self-report of no meth use).

  Through study completion, an average of 6 months

Study Arms (1)

Primary Arm

EXPERIMENTAL

Components of the Affect Therapeutic Program for MUD 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-based addiction counseling with clinical personnel, twice-weekly group therapy, and monthly psychiatrist appointments for evaluation and management and medication support, as needed.

Other: Affect Treatment Program for Methamphetamine Use Disorder

Interventions

Affect Treatment Program for Methamphetamine Use Disorder OTHER

Telemedicine based group and individual therapy, drug screens, contingency management, therapeutic app engagement, psychiatric interventions for adjuvant medications.

Primary Arm

Eligibility Criteria

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

You may qualify if:

• To be eligible to participate in the study, prospective participants must:
• Be 18 years of age or older;
• Have methamphetamine use disorder (MUD), confirmed by DSM-5 criteria for stimulant use disorder, methamphetamine type, endorsing \>3 DSM-5 Checklist items (see Note below\*);
• Have stated interest in reducing and/or stopping methamphetamine use;
• Have and be able to use a smartphone and agree to download and use the Affect app as part of study-related procedures;
• Be English speaking and have reading capacity sufficient to understand explanations of study procedures and the informed consent to participate, which will be prepared at 7th-8th grade level;
• Have a mailing address, P.O. box, or other means of receiving packages (for biologic sample kits) as a resident of Arizona;
• Be able to freely give informed consent and be willing to electronically sign the digital informed consent to participate in the study;
• Be willing to comply with study procedures, including use of the Affect app consistent with the study protocol and therapeutic activities.

You may not qualify if:

• Individuals will be precluded from enrolling in the study if they endorse (or if there is indication of) any of the following items. Already-enrolled participants will be withdrawn from study participation upon emergence of an excluded condition (except pregnancy):
• Serious medical condition (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 at screening (DSM5 checklist);
• Currently pregnant or planning on becoming pregnant (which may indicate a need for higher level of care to ensure safety of the woman and fetus);
• Have been in a prior study of pharmacological or behavioral treatment for MUD within 6 months of study consent;
• Be concurrently receiving 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.
• Have any other condition that, in the opinion of the PI and the Co-Investigator (Jeff DeFlavio, M.D.), would interfere with participation in and completion of this trial or would put individuals at risk to their well-being.

Sponsors & Collaborators

• Affect Therapeutics, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Affect Therapeutics

New York, New York, 10012, United States

Location

Study Officials

• Kristin Muhlner

  Affect Therapeutics, Inc.

  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: December 27, 2021
• First Posted: January 25, 2022
• Study Start: February 14, 2022
• Primary Completion: November 14, 2022
• Study Completion: December 31, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)