Demonstration of a Digital Care Program for Methamphetamine Use Disorder

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Methamphetamine Abuse

Clinical Trial Details

NCT number	NCT05206175
Study type	Interventional
Source	Affect Therapeutics, Inc.
Contact
Status	Completed
Phase	N/A
Start date	February 14, 2022
Completion date	December 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05916989` - Stimulant Use and Methylation in HIV
Recruiting	`NCT04927143` - Encouraging Abstinence Behavior in a Drug Epidemic	Phase 2
Completed	`NCT03226223` - Pharmacogenetics of Naltrexone for Stimulant Abuse	Phase 2
Not yet recruiting	`NCT05593796` - Cognitive Behavioral Therapy(CBT) in Treatment of Methamphetamine Use Disorder	N/A
Completed	`NCT02907853` - Contingency Management for Meth in South Africa Methamphetamine Abuse in South Africa	N/A
Recruiting	`NCT04616625` - Cardiovascular Effects of Prenatal Methamphetamine Exposure
Recruiting	`NCT04061941` - Change in Cognitive Function in Stimulant Users
Completed	`NCT01967381` - Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse	Early Phase 1
Terminated	`NCT01019707` - Safety Assessment of Atomoxetine With MA IV Administration	Phase 1
Completed	`NCT01011829` - Varenicline vs Placebo for the Treatment of Methamphetamine Dependence	Phase 2
Active, not recruiting	`NCT04706624` - Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics	N/A
Recruiting	`NCT05700994` - Peer Engagement in Methamphetamine Harm-Reduction With Contingency Management (PEER-CM)	N/A
Completed	`NCT04109014` - FASTLANE II: Reducing Sex, Drug, and Mental Health Risk	N/A
Completed	`NCT03336866` - Study of Antibody for Methamphetamine Outpatient Therapy	Phase 1/Phase 2
Completed	`NCT01822132` - Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade	N/A
Completed	`NCT01062451` - An ACE Inhibitor (Perindopril) or an Angiotensin Receptor Blocker (Candesartan) as a Treatment for Methamphetamine Dependence	Phase 1
Not yet recruiting	`NCT06233799` - Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder	Phase 3
Recruiting	`NCT05521854` - Contingency Management for Drug Use: Does Age Matter?	N/A
Completed	`NCT01063205` - NAC as a Potential Treatment for Methamphetamine Dependence	Phase 1
Not yet recruiting	`NCT05334914` - ACT for Methamphetamine Use Disorder in Women and Gender Non-Conforming Individuals	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.