Opioid Use, Opioid Use Disorder, Substance Use Disorders
Conditions
Brief summary
The goal of this clinical trial is to demonstrate the commercial potential for a novel virtual reality (VR) intervention in preparation for Phase II development. This clinical trial will test the VR intervention for efficacy in reducing opioid use, increasing abstinence, and other self-reported and behavioral focus on future outcomes in individuals in early recovery from opioid use disorder. * Will the VR group, compared to the control group, have a lower number of opioid use days? * Will the VR group, compared to the control group, have longer periods of abstinence at the 30-day follow-up? * Will the VR group, compared to the control group, have significantly increased opioid abstinence rates? * Will the VR group, compared to baseline and the control group, show increased future self-identification post-VR intervention? * Will the VR group, compared to baseline and the control group, show increased future orientation post-VR intervention? * Will the VR group, compared to baseline and the control group, show an increased preference for delayed rewards in a laboratory delay discounting task post-VR intervention? * Will the VR group, compared to baseline and the control group, exceed in behavioral effects (i.e., future self-identification, future orientation, and increased preference for delayed rewards) at the 30-day follow-up? Researchers will compare the VR test group and the control group to see if there are differences in the results for the questions outlined above.
Interventions
DEVICEVirtual Reality Avatar Intervention
In the Virtual Reality Avatar Intervention experience, participants will see an avatar resembling themselves in a park setting.
DEVICEVirtual Reality Empty Park
The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.
Sponsors
Indiana University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment.
Intervention model description
Two groups: Experimental and Control
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Abstinence between ≥14 days and ≤ 1 year * 18-60 years old * Verbal endorsement of commitment to recovery * Outpatient * Psychotropic drugs for SUD-comorbidity * Mu-Opioid drugs * Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit * English comprehension
Exclusion criteria
* Unstable medical disorders * Outside the age range of 18-60 * Habitual drug use * Smell/taste disorders * Unstable psychiatric conditions * Extravagant/elaborate face tattoos
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced Number of Drug Using Days | Study Day Visit; 30-day Follow-up Visit. | The VR Avatar experience will change drug using days. |
| Increased Length of Abstinence | Study Day Visit (Day 1); 30-day Follow-up Visit. | The VR Avatar experience will change the length of abstinence periods. |
| Change in Overall Abstinence | Study Day Visit (Day 1); 30-day Follow-up Visit. | The VR Avatar experience, compared to treatment as usual will change abstinence, measured using urine drug analysis, self report, and a timeline follow-back assessing for substances used from study day to study completion. |
| Future Self-Continuity | Study Day Visit (Day 1); 30-day Follow-up Visit | The VR Avatar Experience will change future self-continuity. Future self-continuity and change between two time points will also be measured using a proprietary future-self-continuity assessment administered at Study Day Visit (Day 1), and again at the 30-Day Follow-up Visit. |
| Future Time Orientation | Study Day Visit (Day 1); 30-day Follow-up Visit. | The Virtual Reality Avatar experience will change orientation toward the future, which will be measured using the Zimbardo Time Perspective Inventory (ZTPI). The ZTPI contains five subscales, two of which will be administered and measured. Items within each subscale are scored from 1, "very uncharacteristic," to 5, "very characteristic." The subscales used are Present-Hedonistic--15 items, higher scores indicative of worse outcomes, and Future--10 items, higher scores indicative of better outcomes. |
| Delayed Reward | Study Day Visit (Day 1); 30-day Follow-up Visit. | The Virtual Reality Avatar experience will change preference for delayed rewards, which will be measured using a behavioral delay discounting task. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrandon G Oberlin, PhD
Indiana University
Outcome results
None listed