Mobile Software Application Intervention Including Cognitive Tasks
Phase: EARLY_PHASE1
Conditions: Cognitive Function Abnormal
Sponsor: NXTech

Protocol NX-21270 
 
Protocol NX-21270 
Cover Sheet 
 
 
Official Title:  Boost Study 21270 (Cognition) 
 
ClinicalTrials.gov ID (NCT number):  NCT05990335 
 
Document Date:   April 17, 2022 
 
Document Description:  Protocol (Precis) 
 
 
 
 
 
 
 
Confidentiality Statement 
This document contains confidential and proprietary information of sponsor NXTech Inc, provided solely 
for the purpose of reviewing or performing this study under compliance of federal reporting 
requirements; and is not intended as public disclosure or other dissemination activity which may in any 
way limit intellectual property rights assertions by the sponsor. 
 
 
Practices Statement 
This study is to be performed in full compliance with the protocol and applicable oversight body and 
regulatory requirements. All required study documentation and data will be archived in accordance with 
preauthorized policies and procedures. 

Protocol NX-21270 
1. 
Background 
Opioid use disorder affects an estimated 1.9 million people in the United States (2014) with an 
estimated 586,000 of cases related to heroin use, and with all patients suffering harms as a result of 
this chronic condition. The economic impact of illicit prescription opioid abuse alone is estimated to 
be $53-72 billion, imposing high costs to society as a whole. In previous work, NXTech developed an 
mHealth application derived from cognitive science findings. In this study mHealth-based exercises 
are provided to healthy individuals to inform design of optimal interventions for OUD. 
 
2. 
Protocol and Procedures 
This study consists of a feasibility study of the mHealth platform for cognitive training completion in 
two configurations.  
 
Participants in the beta test (see SAP for subjects recruitment targets) will be invited to participate by 
investigators, in a remote study coordinated by the investigator institution. 
 
IRB approval will be obtained by the local host institution prior to any human subjects activities. 
If no waiver of written consent is granted under IRB oversight, subjects will provide informed consent 
in writing before enrollment.  There is no more than minimal risk expected to participants in the 
study. 
 
The experiments will be completed online and users will be required supply their own standard 
electronic mobile device to complete the study.  
 
Participants will be recruited to engage with the application for a recommended period of 150 
minutes per week for 8 weeks total, with enrollment as detailed in Section 3. During the study period, 
we will evaluate application feasibility by gathering optional open-ended and closed-ended feedback 
along with required measures of user adherence to the intervention and requested measures of task 
performance as delivered on a numerical score basis by the mHealth application.  
 
3. 
Recruitment and Enrollment  
Recruitment will proceed through two stages. First, participants will be pre-screened for their 
eligibility for the second stage and their baseline rates will be determined, in addition to an optional 
survey relating to health behaviors, as the selection of the site investigator and subject to remote 
platform screening acceptance. Second, participants meeting eligibility criteria below and who occupy 
the upper 25% quartile of scored choices will be invited to an 8-week long follow-up study. 
Compensation for participation will be set at a rate of $5 per hr (or as adjusted based on prevalent 
remuneration rates at the time of study execution).  
 
Subjects will only be tracked by an assigned numeric ID that is unassociated with an individual's 
personally-identifiable information.  
 
Inclusion Criteria are as follows: 
  Age 18 years and above 

Protocol NX-21270 
  Fluent in English 
  Resides in the United States 
  Score on prescreen task is in 25% quartile 
  Familiar with smartphone device app installation and device usage 
  Possesses a compatible smartphone 
 
Exclusion Criteria:  None if qualified under Inclusion Criteria 
 
 
4. 
Compliance Procedures  
This study will be performed in accordance with Protocol requirements and applicable oversight body 
policies.  
 
Data collection will be primarily in electronic format. All required study documentation and data 
records will be archived in accordance with preauthorized policies and procedures. Investigators will 
assure that either a wavier of consent is granted under IRB approval, or that informed consent is 
obtained prior to performing any research procedures. Investigators will ensure that all participants 
meet eligibility requirements, and that the study is conducted according to the IRB-approve research 
plan and in accordance with the Federalwide Assurance certification of the site.  
 
Adverse events and serious adverse events are not expected but will be recorded and addressed 
under institutional procedures. 
 
Documentation and data will be stored and archived in a secure format for at least 2 years and for the 
duration required by the Sponsor and collaborating sites. 
 
 
5. 
Biological Samples 
None will be collected or analyzed.