Clinical Trials Logo

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


NCT number NCT05206175
Study type Interventional
Source Affect Therapeutics, Inc.
Contact Kristin Muhlner
Phone 17036238113
Email [email protected]
Status Recruiting
Phase N/A
Start date December 27, 2021
Completion date September 30, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04927143 - Encouraging Abstinence Behavior in a Drug Epidemic Phase 3
Completed NCT03226223 - Pharmacogenetics of Naltrexone for Stimulant Abuse Phase 2
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
Recruiting NCT04706624 - Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics 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
Recruiting NCT05034874 - Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 Phase 2
Not yet recruiting NCT05334914 - ACT for Methamphetamine Use Disorder in Women and Gender Non-Conforming Individuals N/A
Completed NCT01063205 - NAC as a Potential Treatment for Methamphetamine Dependence Phase 1
Recruiting NCT03709667 - Exercise in Methamphetamine Use Disorder Upregulation and Neural Function Early Phase 1
Completed NCT01073319 - Rivastigmine as a Treatment for Methamphetamine Dependence Phase 1
Recruiting NCT03884946 - The Getting Off App for Methamphetamine-Using Gay and Bisexual Men N/A
Recruiting NCT04907357 - rTMS for Stimulant Use Disorders N/A