Enhancing Prospective Thinking in Early Recovery (PARK)

Opioid Use Clinical Trial

— PARK  

Official title:

Enhancing Prospective Thinking in Early Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908097
• Other study ID #: 1805574553; Aims 7-8
• Secondary ID: PARK1R41DA055405
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: Sarah Turo, BA
• Phone: 3179637220
• Email: sturo[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Device:
• Virtual Reality Avatar Intervention
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.
• Virtual Reality Empty Park
The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine - Goodman Hall	Indianapolis	Indiana
United States	IUSM - Goodman Hall	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced Use of Drug Using Days	The VR Avatar experience will change drug using days.	Study Day Visit; 30-day Follow-up Visit.
Primary	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.
Primary	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.
Primary	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
Primary	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.	Study Day Visit (Day 1); 30-day Follow-up Visit.
Primary	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.