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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA029396-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question[s] this trial aims to answer are:
Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups 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 Park Virtual Reality Avatar |
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| Treatment As Usual | Placebo Comparator | Participants in this arm will receive the following interventions: Virtual Reality Park |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | They will receive a Virtual Reality Park experience, which is an empty park with no avatars. They will then have a Virtual Reality Avatar experience, where they will see an avatar resembling themselves in a park setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced Use of Drug Using Days | The Virtual Reality Avatar experience will reduce drug using days. | Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit |
| Increased Length of Abstinence | The Virtual Reality Avatar experience will increase the length of abstinence periods. | Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit. |
| Increased (overall) Abstinence | The Virtual Reality Avatar experience will increase abstinence. | Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit. |
| Future Self-identification with Future Self Continuity Questionnaire | The Virtual Reality Avatar experience will increase future self-identification. | Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit |
| Future Time Perspective with the Delayed Discounting Behavioral Task and Future Self Continuity Questionnaire | The Virtual Reality Avatar experience will increase future time perspective. | Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit. |
| Delayed Reward Preference with the Delayed Discounting Behavioral Task | The Virtual Reality Avatar experience will increase preference for delayed rewards. | Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Turo, BA | Contact | 317-963-7220 | sturo@iu.edu | |
| Colton Lind, BS | Contact | 317-963-2554 | cmlind@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brandon G Oberlin, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine - Goodman Hal | Recruiting | Indianapolis | Indiana | 46202 | United States |
Pre-determined participant 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 |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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 | Device | They will receive a Virtual Reality Park experience, which is an empty park with no avatars. |
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