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Enhancing Prospective Thinking in Early Recovery (PARK) (PARK)

Primary Purpose

Opioid Use, Opioid Use Disorder, Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Avatar Intervention
Virtual Reality Empty Park
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Opioid Use

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University School of Medicine - Goodman HallRecruiting
  • IUSM - Goodman HallRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Virtual Reality

Treatment As Usual (Control)

Arm Description

Participants in this arm will receive the following interventions: Treatment As Usual (Empty Virtual Reality Park) Virtual Reality Avatar (Intervention)

Participants in this arm will receive the following interventions: Treatment As Usual (Empty Virtual Reality Park)

Outcomes

Primary Outcome Measures

Reduced Use of Drug Using Days
The VR Avatar experience will change drug using days.
Increased Length of Abstinence
The VR Avatar experience will change the length of abstinence periods.
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.
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.
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.
Delayed Reward
The Virtual Reality Avatar experience will change preference for delayed rewards, which will be measured using a behavioral delay discounting task.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2023
Last Updated
July 13, 2023
Sponsor
Indiana University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05908097
Brief Title
Enhancing Prospective Thinking in Early Recovery (PARK)
Acronym
PARK
Official Title
Enhancing Prospective Thinking in Early Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid Use Disorder, Substance Use Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: Experimental and Control
Masking
Participant
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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Participants in this arm will receive the following interventions: Treatment As Usual (Empty Virtual Reality Park) Virtual Reality Avatar (Intervention)
Arm Title
Treatment As Usual (Control)
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive the following interventions: Treatment As Usual (Empty Virtual Reality Park)
Intervention Type
Device
Intervention Name(s)
Virtual Reality Avatar Intervention
Intervention Description
In the Virtual Reality Avatar Intervention experience, participants will see an avatar resembling themselves in a park setting. The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Empty Park
Intervention Description
The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.
Primary Outcome Measure Information:
Title
Reduced Use of Drug Using Days
Description
The VR Avatar experience will change drug using days.
Time Frame
Study Day Visit; 30-day Follow-up Visit.
Title
Increased Length of Abstinence
Description
The VR Avatar experience will change the length of abstinence periods.
Time Frame
Study Day Visit (Day 1); 30-day Follow-up Visit.
Title
Change in Overall Abstinence
Description
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.
Time Frame
Study Day Visit (Day 1); 30-day Follow-up Visit.
Title
Future Self-Identification
Description
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.
Time Frame
Study Day Visit (Day 1); 30-day Follow-up Visit
Title
Future Time Orientation
Description
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.
Time Frame
Study Day Visit (Day 1); 30-day Follow-up Visit.
Title
Delayed Reward
Description
The Virtual Reality Avatar experience will change preference for delayed rewards, which will be measured using a behavioral delay discounting task.
Time Frame
Study Day Visit (Day 1); 30-day Follow-up Visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megayn E Lewandowski, BS
Phone
3179637220
Email
melewand@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Turo, BA
Phone
3179637218
Email
sturo@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon G Oberlin, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine - Goodman Hall
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megayn Lewandowski, BS
Phone
517-348-6016
Email
melewand@iu.edu
First Name & Middle Initial & Last Name & Degree
Brandon G Oberlin, PhD
Facility Name
IUSM - Goodman Hall
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megayn E Lewandowski, BS
Phone
517-348-6016
Email
melewand@iu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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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Enhancing Prospective Thinking in Early Recovery (PARK)

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