Loading clinical trials...

Demonstration of a Digital Care Program for Methamphetamine Use Disorder | Clinical Trials | Clareo Health

COMPLETEDNA

Demonstration of a Digital Care Program for Methamphetamine Use Disorder

NCT05206175•Affect Therapeutics, Inc.

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).

Detailed Description

The project includes a clinical trial that will assemble data on the functionality of the app in engaging patients and delivering treatment components and related services, using outputs to guide rapid refinements of the app's functions (e.g., active and passive data collection, patient inference engine, triggers for clinician actions, user interfaces). The project will analyze these and other aspects of the app and program to assess their associations with patient engagement, participation, and retention, providing indication of the overall program's clinical utility. Aim 1. Confirm the technical merit and feasibility of the Affect app and its delivery of the Affect digital care program in real-world practice based on results from the clinical trial. Aim 2. Identify components of the Affect app and the Affect digital care program that correlate with patient engagement, participation, retention, and changes in methamphetamine use. Aim 3. Use results to iteratively refine the Affect app and care program to improve treatment of MUD toward substantiating commercialization. Demonstrating the technical merit, feasibility, and clinical utility of the Affect app and digital care platform could lead to improved clinical care for the 1.6 million people in the nation who need treatment for MUD. Results of this project have high potential to inform additional work to advance commercializability of the Affect program and its app, which would increase access to affordable, effective care for those who never receive treatment among the 2 million in need. If technical merit is demonstrated and the program is shown to be feasible and effective in retaining participants in treatment, the Affect app will be an important element in efficiently achieving optimum patient outcomes at reasonable cost.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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), confirmed by DSM-5 criteria for stimulant use disorder, methamphetamine type, endorsing \>3 DSM-5 Checklist items (see Note below\*);
•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 study-related procedures;
•5. 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;
•6. Have a mailing address, P.O. box, or other means of receiving packages (for biologic sample kits) as a resident of Arizona;
•7. Be able to freely give informed consent and be willing to electronically sign the digital informed consent to participate in the study;
•8. Be willing to comply with study procedures, including use of the Affect app consistent with the study protocol and therapeutic activities.
•* Note: The inclusion criterion of MUD is established via the screening process involving questionnaires about meth use and the candidate's endorsement of DSM-5 criteria for MUD. We are confident in this process, given the fact that all of the participants (N=57) enrolled in our field study (Study # 1302084, IRB Tracking # 20210518, completed June 2021) tested positive for meth by the twice-weekly biologic tests during Weeks 1 and 2 of the intervention period, which confirms validity of the eligibility criterion of MUD determined by DSM-5 Checklist at screening.

Exclusion Criteria

•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):
•1. Serious medical condition (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 at screening (DSM5 checklist);
•4. 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);
•5. Have been in a prior study of pharmacological or behavioral treatment for MUD within 6 months of study consent;
•6. Be concurrently receiving 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.
•8. 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.

Locations (1)

Affect Therapeutics

New York, New York, United States

Key Dates

Start Date

February 14, 2022

Primary Completion Date

November 14, 2022

Completion Date

December 31, 2022

Last Updated

January 11, 2023

Enrollment

100

ACTUAL participants

Conditions

Methamphetamine Abuse

Interventions

Affect Treatment Program for Methamphetamine Use Disorder

OTHER

Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder

NCT06233799

Methamphetamine-dependenceMethamphetamine Abuse

View study

COMPLETEDNA

Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics

NCT04706624

Methamphetamine AbuseOpioid-use Disorder+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Demonstration of a Digital Care Program for Methamphetamine Use Disorder

Inclusion Criteria

Exclusion Criteria

Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder

Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics

tACS Treatment for Cognitive Impairments in Methamphetamine Addicts

rTMS for Stimulant Use Disorders

Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder

Depression Intervention Among Gay and Bisexual Men Receiving Treatment for Methamphetamine Use