Opioid-use DisorderNCT05034276
Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
A study testing MORE-VR in people with Opioid-use Disorder, run by University of Utah at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- MORE-VR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 22 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- DSM-5 opioid use disorder diagnosis
- treated with medications for opioid use disorder (MOUD)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, 84112
About this study
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).
- Conditions
- Opioid-use Disorder
- Being tested
- MORE-VR
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORE-VROther
Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
| Study group | Role | What they receive |
|---|---|---|
| MORE-VR | Experimental | Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. Receives: Other: MORE-VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events and/or Serious Adverse Events
Number of participants who reported adverse events and serious adverse events.
Measured: Baseline through week 8
Secondary outcomes (3)
Engagement
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.
Measured: Baseline through week 8
Numeric Rating Scale of State Craving
Craving measured on a 0 to 10 numeric rating scale, with 0 indicating no craving and 10 indicating extreme craving.
Measured: Baseline through week 8
Numeric Rating Scale of State Positive Affect
Positive affect measured on a 0 to 10 numeric rating scale, with 0 indicating no positive affect and 10 indicating very high positive affect.
Measured: Baseline through week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start4 Oct 2021
- Primary completion1 Apr 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- BehaVR LLC, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Eric Garland, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034276
- Sponsor's protocol ID
- IRB_00141495
- Other IDs
- R44DA053848
- Status last verified
- Jul 2023
- First submitted
- 1 Sep 2021
- Last updated
- 20 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garland EL, Recasens M, Taple BJ, Donaldson GW, Weisberg RB. Virtual reality-based Mindfulness-Oriented Recovery Enhancement (MORE-VR) as an adjunct to medications for opioid use disorder: a Phase 1 trial. Ann Med. 2024 Dec;56(1):2392870. doi: 10.1080/07853890.2024.2392870. Epub 2024 Aug 22.
PubMed 39172534
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05034276
- Acronym / sponsor ID
- IRB_00141495
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- BehaVR LLC, National Institute on Drug Abuse (NIDA)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Posted 20 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MORE-VR | Experimental | Other: MORE-VRMindfulness-Oriented Recovery Enhancement deployed over virtual reality. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- DSM-5 opioid use disorder diagnosis
- treated with medications for opioid use disorder (MOUD)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORE-VRMindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality. | Other | MORE-VR |
Primary outcome
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.
3 secondary outcomes
Engagement
Time frame: Baseline through week 8
Numeric Rating Scale of State Craving
Time frame: Baseline through week 8
Numeric Rating Scale of State Positive Affect
Time frame: Baseline through week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39172534Garland EL, Recasens M, Taple BJ, Donaldson GW, Weisberg RB. Virtual reality-based Mindfulness-Oriented Recovery Enhancement (MORE-VR) as an adjunct to medications for opioid use disorder: a Phase 1 trial. Ann Med. 2024 Dec;56(1):2392870. doi: 10.1080/07853890.2024.2392870. Epub 2024 Aug 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MORE-VR in people with Opioid-use Disorder, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events and/or Serious Adverse Events (time frame: Baseline through week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05034276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.