Status:
COMPLETED
Demonstration of a Digital Care Program for Methamphetamine Use Disorder
Lead Sponsor:
Affect Therapeutics, Inc.
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Methamphetamine Abuse
Eligibility:
All Genders
18+ years
Phase:
NA
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 Aff...
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 rapi...
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), 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.
- 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
- 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.
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05206175
Start Date
February 14 2022
End Date
December 31 2022
Last Update
January 11 2023
Active Locations (1)
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1
Affect Therapeutics
New York, New York, United States, 10012