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| ID | Type | Description | Link |
|---|---|---|---|
| PARK | Other Identifier | IndianaU | |
| 1R41DA055405-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality | Experimental | Participants in this arm will receive the following interventions: Virtual Reality Avatar VR plus Treatment As Usual (Intervention) |
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| Sham VR (Control) | Sham Comparator | Participants in this arm will receive the following interventions: Sham VR plus Treatment As Usual (Empty Virtual Reality Park) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Avatar Intervention | Device | In the Virtual Reality Avatar Intervention experience, participants will see an avatar resembling themselves in a park setting. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduced Use of Drug Using Days | The VR Avatar experience will change drug using days. | Study Day Visit; 30-day Follow-up Visit. |
| Increased Length of Abstinence | The VR Avatar experience will change the length of abstinence periods. | Study Day Visit (Day 1); 30-day Follow-up Visit. |
| Change in Overall Abstinence | The VR Avatar experience, compared to treatment as usual will change abstinence, measured using a timeline follow-back assessing for substances used from enrollment to study completion. | Study Day Visit (Day 1); 30-day Follow-up Visit. |
| Future Self-Identification | The VR Avatar Experience will change future self-identification. Future self-identification 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. | Study Day Visit (Day 1); 30-day Follow-up Visit |
| Future Time Orientation | 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, and items within each subscale are scored from 1, "very uncharacteristic," to 5, "very characteristic." The subscales are 1) Past-Negative--10 items, higher scores indicative of worse outcomes; 2) Present-Hedonistic--15 items, higher scores indicative of worse outcomes; 3) Future--10 items, higher scores indicative of better outcomes; 4) Past-Positive--9 items, higher scores indicative of better outcomes; and 5) Present-Fatalistic--9 items, higher scores indicative of worse outcomes. Subscales are combined into "future" and "present" categories, then totaled, with higher total scores indicative of worsened outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon G Oberlin, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine - Goodman Hall | Indianapolis | Indiana | 46202 | United States | ||
| IUSM - Goodman Hall |
The IPD will be shared in accordance with the National Institutes of Health National Data Archive requirements and upon the consent of the study participant.
Data will be shared at the specified submission deadlines assigned by the National Institutes of Health (typically every April or October). Data will be available upon the discretion of the National Institutes of Health.
No individually identifiable participant data will be submitted to the National Data Archive. All collected participant data is de-identified, and will be made available for other researchers to use upon requests submitted through the National Data Archive portal, and approval from the principal investigator.
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Two groups: Experimental and Control
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All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment.
| Virtual Reality Empty Park | Device | The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars. |
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| Study Day Visit (Day 1); 30-day Follow-up Visit. |
| Delayed Reward | The Virtual Reality Avatar experience will change preference for delayed rewards, which will be measured using a behavioral delay discounting task. | Study Day Visit (Day 1); 30-day Follow-up Visit. |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Serenity Lane Alcohol & Drug Treatment | Coburg | Oregon | 97402 | United States |