Demonstration of a Digital Care Program for Methamphetamine Use Disorder

NCT ID: NCT05206175

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2022-12-31

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.

Conditions

Methamphetamine Abuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primary Arm

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.

Group Type: EXPERIMENTAL

Affect Treatment Program for Methamphetamine Use Disorder

Intervention Type: OTHER

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

Interventions

Affect Treatment Program for Methamphetamine Use Disorder

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Affect Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Muhlner

Role: PRINCIPAL_INVESTIGATOR

Affect Therapeutics, Inc.

Locations

Affect Therapeutics

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R43DA055394

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Methamphetamine Study

Identifier Type: -

Identifier Source: org_study_id