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Clinical Trials/NCT05034276
NCT05034276
Completed
N/A

Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder

University of Utah1 site in 1 country34 target enrollmentOctober 4, 2021
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ConditionsOpioid-use Disorder

Overview

Phase
N/A
Intervention
Not specified
Conditions
Opioid-use Disorder
Sponsor
University of Utah
Enrollment
34
Locations
1
Primary Endpoint
Number of Participants With Adverse Events and/or Serious Adverse Events
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a Phase 1 trial that aims to establish the safety of MORE-VR, as well as to collect feasibility, usability, and engagement data, for patients receiving medications for opioid use disorder (mOUD).

Registry
clinicaltrials.gov
Start Date
October 4, 2021
End Date
July 22, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Garland

Distinguished Professor

University of Utah

Eligibility Criteria

Inclusion Criteria

  • •Age 18 or older
  • •DSM-5 opioid use disorder diagnosis
  • •treated with medications for opioid use disorder (MOUD)

Exclusion Criteria

  • •Mindfulness intervention experience (MBSR, MBRP)
  • •Active psychosis or high risk of suicidality
  • •Cognitive impairment (per self-report or report by clinician)
  • •Unwilling or unable to remain in MOUD treatment for duration of study

Outcomes

Primary Outcomes

Number of Participants With Adverse Events and/or Serious Adverse Events

Time Frame: Baseline through week 8

Number of participants who reported adverse events and serious adverse events.

Secondary Outcomes

  • Numeric Rating Scale of State Craving(Baseline through week 8)
  • Engagement(Baseline through week 8)
  • Numeric Rating Scale of State Positive Affect(Baseline through week 8)

Study Sites (1)

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