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OpenTrials
Completed

NCT Number: NCT05034276

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

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).

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center on Mindfulness and Integrative Health Intervention Development

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MORE-VR

Other

Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.

Primary outcomes

  1. 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

  1. Engagement

    Time frame: Baseline through week 8

    Net Promoter Score (NPS) is a engagement and satisfaction measurement taken from asking participants how likely they were to recommend the MORE-VR intervention to others on a scale of 0-10. Net Promoter Score (NPS) is calculated by subtracting the percentage of customers who answer the NPS question with a 6 or lower (known as 'detractors') from the percentage of customers who answer with a 9 or 10 (known as 'promoters'). The summary Net Promoter Score is reflected as a percentage.

  2. Numeric Rating Scale of State Craving

    Time frame: Baseline through week 8

    Craving measured on a 0 to 10 numeric rating scale, with 0 indicating no craving and 10 indicating extreme craving.

  3. Numeric Rating Scale of State Positive Affect

    Time frame: Baseline through week 8

    Positive affect measured on a 0 to 10 numeric rating scale, with 0 indicating no positive affect and 10 indicating very high positive affect.

Other outcomes

  1. Desire for Drugs

    Time frame: Baseline, week 8

    Desires for Drugs Questionnaire

  2. Trait Positive and Negative Affect

    Time frame: Baseline, week 8

    Positive and Negative Affect Schedule

  3. Coping Self-efficacy

    Time frame: Baseline, week 8

    Drug Taking Confidence Questionnaire

  4. Cue-elicited Heart Rate

    Time frame: Baseline through week 8

    Heart rate during cue exposure minus baseline heart rate

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • BehaVR LLC
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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