Opioid Use Disorder Clinical Trial
Official title:
Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder: A Phase 2 Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | May 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or older - current DSM-5 OUD diagnosis - prescribed medications for opioid use disorder (e.g., buprenorphine, methadone) Exclusion Criteria: - completion of a standardized mindfulness intervention (e.g., MORE, MBRP, MBSR) - active psychosis or suicidality - reports, or is noted by clinical or study staff as showing cognitive impairment - condition which might be contraindicated for VR use including seizure disorder, vertigo, severe motion sickness, recent concussion |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
BehaVR LLC | National Institute on Drug Abuse (NIDA), University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Drug cue reactivity | For a subset of participants, we will asses change from baseline in neurophysiological response during lab-based task involving presentation of drug cues designed to measure cue-reactivity. | Baseline to immediately after the intervention | |
Other | Emotion regulation | For a subset of participants, we will assess change from baseline in neurophysiological response during lab-based task involving presentation of emotional stimuli. | Baseline to immediately after the intervention | |
Other | Theta oscillations | For a subset of participants, we will assess theta oscillations as measured by EEG during meditation | Baseline to immediately after the intervention | |
Primary | Days of opioid use | Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen | Baseline to post-treatment assessment (8 weeks) | |
Secondary | Days of opioid use at follow-up | Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen | Baseline to 3 months post treatment (20 weeks from baseline) | |
Secondary | Time until opioid lapse | Number of days until opioid lapse assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen | Baseline through 3 month post-treatment follow-up | |
Secondary | Time until dropout from opioid use disorder treatment | Number of days unti dropout from treatment, assessed by Timeline Followback and chart review | Baseline through 3 month post-treatment follow-up | |
Secondary | Desire for drugs | Desires for Drug Questionnaire, range from 14 to 98, higher scores indicating more intense desires for drugs | Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period | |
Secondary | Opioid craving | 0-10 numeric rating scale via ecological momentary assessment (0=no craving, 10=extreme craving). | Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period | |
Secondary | Positive Affect | 0-10 numeric rating scale via ecological momentary assessment (0=no positive affect, 10=extremely strong positive affect). | Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period | |
Secondary | Negative Affect | 0-10 numeric rating scale via ecological momentary assessment (0=no negative affect, 10=extremely strong negative affect). | Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period | |
Secondary | Positive and Negative Affect Schedule | A 20-item scale measuring both positive and negative affect, where each affective term is rated on a scale of 1 (not at all) to 5 (very much) | Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period | |
Secondary | Distress | Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress. | Baseline through 3 month post-treatment follow-up | |
Secondary | Health-related Quality of Life | World Health Organization Quality of Life Scale Quality of life measured by the World Health Organization Quality of Life Scale (WHO-5), scores ranging from 0 to 25, with higher scores indicating better quality of life. | Baseline through 3 month post-treatment follow-up |
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