BoostOne Study (MHealth)
Phase: PHASE1
Conditions: Addiction
Sponsor: NXTech

Protocol NX-31380 
 
Protocol NX-31380 
Cover Sheet 
 
 
Official Title:  Boost Study 31380 (mHealth) 
 
ClinicalTrials.gov ID (NCT number):  NCT05757453 
 
Document Date:   March 30, 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-31380 
1. 
Background 
Opioid use disorder (OUD) 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 to assist in symptom management for 
OUD. In this study we provide mHealth-based exercises to individuals diagnosed and in treatment for 
opioid use disorder to inform design of optimal mHealth (mobile healthcare) interventions for OUD. 
 
2. 
Protocol and Procedures 
This study consists of a feasibility study of the mHealth platform for cognitive training completion in a 
single-arm study of individuals in supervised treatment at the site of recruitment, under the care of 
an independent clinical provider.  
 
Participants in this study of the mHealth platform (see SAP for recruitment targets) will be invited to 
participate by study investigators, in a local study of 8 week duration, with an optional extension of 
up to 8 additional weeks upon participant election. 
 
IRB approval will be obtained by the local host institution prior to any human participants activities. 
Procedures are intended to adhere to the Good Clinical Practices Consolidated Guideline and the 
Declaration of Helsinki. Monitoring data and safety of participants will be performed by the Principal 
Investigator and an applicable human participants Institutional Review Board (IRB) with authorized 
recognition of the IRB by the study site. All participants must provide informed consent in writing 
before enrollment and will be informed that they may disenroll at any time. There is no more than 
minimal risk expected to participants in the study. 
 
In this study, participants are requested engage with mHealth platform interactions for the duration 
of the study period of at least 8 weeks, in addition to completing weekly assessments.  Enrollment 
criteria are provided in Section 3. Participants supply their own standard electronic mobile device to 
complete the study or may receive a loaner device. All mobile devices used in this study will be 
standard commercial units. 
 
After completion of the final day of participation by the final participant, full analysis of recorded data 
will be completed. During the study period, intervention feasibility will be assessed using measures of 
utilization, in addition to structured and open-ended user feedback. Primary outcome measures are  
user acceptability of the and secondarily for treatment-related effects of the mHealth application as 
an addition to usual care.   
 
3. 
Recruitment and Enrollment  
Recruitment will proceed under the supervision of a local site investigator, such that participants will 
be offered study participation after provision of written informed consent. Participants will only be 
tracked by an assigned numeric ID that is unassociated with an individual's personally-identifiable 
information.  

Protocol NX-31380 
Patient enrollment will follow, over an up to 4 month period and participants will continue into the 
study in rolling fashion. Individuals will be remunerated for their participation at a rate of up to $50 
per week for the primary study period of 8 weeks (or as adjusted based on prevalent rates at the time 
of study execution).  
 
Demography of enrolled participants will be collected for review during the analysis phase. 
 
Inclusion Criteria are as follows, in addition to concurrent enrollment in a clinician-supervised 
treatment program: 
  Age 18-65 years 
  Diagnosis of opioid use disorder 
  Experiencing symptoms multiple times per week   
  Familiar with smartphone usage 
 
  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 Specimens 
None are expected to be collected specifically under the Protocol.