Opioid UsePARKNCT05908097
Enhancing Prospective Thinking in Early Recovery (PARK)
A study testing Virtual Reality Avatar Intervention and Virtual Reality Empty Park in people with Opioid Use and Opioid Use Disorder, run by Indiana University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Opioid Use, Opioid Use Disorder, Substance Use Disorders
- What is being tested?
- Virtual Reality Avatar Intervention and Virtual Reality Empty Park
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2023to 23 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Unstable medical disorders
- Outside the age range of 18-60
- Habitual drug use
- Smell/taste disorders
- Unstable psychiatric conditions
- Extravagant/elaborate face tattoos
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Serenity Lane Alcohol & Drug Treatment
Coburg, Oregon, 97402
Indiana University School of Medicine - Goodman Hall
Indianapolis, Indiana, 46202
About this study
Official title: Enhancing Prospective Thinking in Early Recovery
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.
- Conditions
- Opioid Use, Opioid Use Disorder, Substance Use Disorders
- Being tested
- Virtual Reality Avatar Intervention, Virtual Reality Empty Park
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Avatar InterventionDevice
In the Virtual Reality Avatar Intervention experience, participants will see an avatar resembling themselves in a park setting.
Virtual Reality Empty ParkDevice
The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Participants in this arm will receive the following interventions:
Virtual Reality Avatar VR plus Treatment As Usual (Intervention) Receives: Device: Virtual Reality Avatar Intervention; Device: Virtual Reality Empty Park |
| Sham VR (Control) | Sham comparator | Participants in this arm will receive the following interventions:
Sham VR plus Treatment As Usual (Empty Virtual Reality Park) Receives: Device: Virtual Reality Empty Park |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced Number of Drug Using Days
The VR Avatar experience will change drug using days.
Measured: Study Day Visit; 30-day Follow-up Visit.
Increased Length of Abstinence
The VR Avatar experience will change the length of abstinence periods.
Measured: 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 urine drug analysis, self report, and a timeline follow-back assessing for substances used from study day to study completion.
Measured: Study Day Visit (Day 1); 30-day Follow-up Visit.
Future Self-Continuity
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.
Measured: 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, 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.
Measured: 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.
Measured: Study Day Visit (Day 1); 30-day Follow-up Visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start4 Apr 2023
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: Experimental and Control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Brandon G. Oberlin, PhD, Indiana University
- Investigators
- Brandon G Oberlin, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908097
- Sponsor's protocol ID
- 1805574553; Aims 7-8
- Other IDs
- PARK, 1R41DA055405-01
- Acronym
- PARK
- Status last verified
- Aug 2026
- First submitted
- 5 May 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Prospective Thinking in Early Recovery
- ClinicalTrials.gov ID
- NCT05908097
- Acronym / sponsor ID
- PARK / 1805574553; Aims 7-8
- Conditions
- Opioid Use, Opioid Use Disorder, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups: Experimental and Control
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual Reality Avatar Intervention, Device: Virtual Reality Empty ParkParticipants in this arm will receive the following interventions: Virtual Reality Avatar VR plus Treatment As Usual (Intervention) |
| Sham VR (Control) | Sham comparator | Device: Virtual Reality Empty ParkParticipants in this arm will receive the following interventions: Sham VR plus Treatment As Usual (Empty Virtual Reality Park) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Abstinence between ≥14 days and ≤ 1 year
- 18-60 years old
- Verbal endorsement of commitment to recovery
- Outpatient
- Psychotropic drugs for SUD-comorbidity
Key exclusion criteria (6 listed)
- Unstable medical disorders
- Outside the age range of 18-60
- Habitual drug use
- Smell/taste disorders
- Unstable psychiatric conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Avatar InterventionIn the Virtual Reality Avatar Intervention experience, participants will see an avatar resembling themselves in a park setting. | Device | Virtual Reality |
| Virtual Reality Empty ParkThe Virtual Reality Empty Park experience is a habituation experience that does not contain avatars. | Device | Sham VR (Control), Virtual Reality |
Primary outcome
Reduced Number of Drug Using Days
Time frame: Study Day Visit; 30-day Follow-up Visit.
The VR Avatar experience will change drug using days.
Increased Length of Abstinence
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Opioid Use
Not yet recruiting
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Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
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Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon G Oberlin, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Avatar Intervention and Virtual Reality Empty Park in people with Opioid Use and Opioid Use Disorder, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced Number of Drug Using Days (time frame: Study Day Visit; 30-day Follow-up Visit.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.