ACTIVE_NOT_RECRUITING

Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to examine the usefulness of a virtual reality-delivered intervention for individuals with opioid use disorder who are taking medication. The main question it aims to answer is will people with opioid use disorder who receive the study intervention, Mindfulness-Oriented Recovery Enhancement in Virtual Reality (MORE-VR), have fewer days in which they use opioids than will people who just receive their usual treatment. Participants will be randomly assigned to either receive 8 weekly sessions of MORE-VR in addition to their usual treatment, or treatment as usual only. Researchers will compare these groups at the end of treatment and three months after treatment is over on number of days of opioid use and time until first opioid use lapse, as well as drug craving and mood.

Official Title

Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder: A Phase 2 Randomized Controlled Trial

Quick Facts

Study Start:2023-09-07
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06021431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * current DSM-5 OUD diagnosis
  3. * prescribed medications for opioid use disorder (e.g., buprenorphine, methadone)
  1. * completion of a standardized mindfulness intervention (e.g., MORE, MBRP, MBSR)
  2. * active psychosis or suicidality
  3. * reports, or is noted by clinical or study staff as showing cognitive impairment
  4. * condition which might be contraindicated for VR use including seizure disorder, vertigo, severe motion sickness, recent concussion

Contacts and Locations

Principal Investigator

Risa Weisberg, PhD
PRINCIPAL_INVESTIGATOR
BehaVR LLC

Study Locations (Sites)

University of California, San Diego
La Jolla, California, 92093
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: BehaVR LLC

  • Risa Weisberg, PhD, PRINCIPAL_INVESTIGATOR, BehaVR LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-07
Study Completion Date2025-09

Study Record Updates

Study Start Date2023-09-07
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Mindfulness
  • Virtual Reality
  • Opioid Use Disorder

Additional Relevant MeSH Terms

  • Opioid Use Disorder