Status:
COMPLETED
Field Study of a Digital Therapeutic Platform to Facilitate Treatment for Methamphetamine-Primary Stimulant Use Disorder
Lead Sponsor:
Affect Therapeutics, Inc.
Conditions:
Methamphetamine Abuse
Eligibility:
All Genders
18+ years
Phase:
NA
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 treat...
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 ...
Eligibility Criteria
Inclusion
- To be eligible to participate in the study, prospective participants must:
- Be 18 years of age or older;
- Have methamphetamine use disorder (MUD) or documented high-risk methamphetamine use history, confirmed by DSM-5 criteria for stimulant use disorder, methamphetamine type;
- 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 treatment and study-related procedures;
- Have a health insurance plan (or Medicaid) to ensure that participants have access to medical care if needed;
- Be English speaking and have reading capacity sufficient to understand explanations of study procedures and the informed consent to participate;
- Be a California resident with a mailing address or P.O. Box
- 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.
- 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 Already enrolled participants will be withdrawn from study participation upon emergence of any excluded condition (except pregnancy):
- 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.
Exclusion
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2022
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT05266716
Start Date
February 18 2021
End Date
January 7 2022
Last Update
March 4 2022
Active Locations (1)
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1
Affect Therapeutics
New York, New York, United States, 10012