Clinical trial NCT05206175: Demonstration of a Digital Care Program for Methamphetamine Use Disorder
Official title: Demonstration of a Digital Care Program for Methamphetamine Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methamphetamine Abuse
Lead sponsor: Affect Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 criteria: 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.

Primary outcomes:
measure: Participation retention and completion of treatment
timeFrame: Up to 8 weeks through the duration of treatment
measure: Patient engagement and program adherence
timeFrame: Up to 8 weeks through the duration of treatment
measure: Effectiveness in reducing meth use
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Affect Therapeutics
state: New York
Study officials:
affiliation: Affect Therapeutics, Inc.
name: Kristin Muhlner
role: PRINCIPAL_INVESTIGATOR
References: