Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05034276
Other study ID # IRB_00141495
Secondary ID R44DA053848
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2021
Est. completion date July 22, 2022

Study information

Verified date July 2023
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 22, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Other:
MORE-VR
Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.

Locations

Country Name City State
United States Center on Mindfulness and Integrative Health Intervention Development Salt Lake City Utah

Sponsors (3)

Lead Sponsor Collaborator
University of Utah BehaVR, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Desire for Drugs Desires for Drugs Questionnaire Baseline, week 8
Other Trait Positive and Negative Affect Positive and Negative Affect Schedule Baseline, week 8
Other Coping Self-efficacy Drug Taking Confidence Questionnaire Baseline, week 8
Other Cue-elicited Heart Rate Heart rate during cue exposure minus baseline heart rate Baseline through week 8
Primary Number of Participants With Adverse Events and/or Serious Adverse Events Number of participants who reported adverse events and serious adverse events. Baseline through week 8
Secondary 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. Baseline through week 8
Secondary 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. Baseline through week 8
Secondary 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. Baseline through week 8
See also
  Status Clinical Trial Phase
Recruiting NCT04157062 - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder N/A
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Completed NCT04505540 - Start Treatment and Recovery for Opioid Use Disorder N/A
Completed NCT03065049 - Transforming Recovery Through Exercise and Community N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Recruiting NCT04650386 - Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients N/A
Completed NCT03715634 - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine Phase 1
Enrolling by invitation NCT04991974 - Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine Phase 2/Phase 3
Completed NCT04122755 - Single Ascending Dose Study of ALA-1000 Phase 1
Recruiting NCT05028998 - COVID-19-Related Opioid Treatment Policy Evaluation
Recruiting NCT04927143 - Encouraging Abstinence Behavior in a Drug Epidemic Phase 2
Recruiting NCT05049460 - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder N/A
Completed NCT05047627 - Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder N/A
Active, not recruiting NCT04129580 - reSET-O RCT (Randomized Controlled Trial) N/A
Recruiting NCT03923374 - Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Suspended NCT02687360 - Imaging the Effects of rTMS on Chronic Pain N/A
Completed NCT04056182 - Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment Phase 2
Completed NCT03766893 - Medication Maintenance Therapy in Community Pharmacy Settings Early Phase 1