Enhancing Prospective Thinking in Early Recovery (PARK)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-04

Study Completion Date

2025-09-14

Brief Summary

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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.

* 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.

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Detailed Description

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Conditions

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Opioid Use Opioid Use Disorder Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups: Experimental and Control

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment.

Study Groups

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Virtual Reality

Participants in this arm will receive the following interventions:

Virtual Reality Avatar VR plus Treatment As Usual (Intervention)

Group Type EXPERIMENTAL

Virtual Reality Avatar Intervention

Intervention Type DEVICE

In the Virtual Reality Avatar Intervention experience, participants will see an avatar resembling themselves in a park setting.

Virtual Reality Empty Park

Intervention Type DEVICE

The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.

Sham VR (Control)

Participants in this arm will receive the following interventions:

Sham VR plus Treatment As Usual (Empty Virtual Reality Park)

Group Type SHAM_COMPARATOR

Virtual Reality Empty Park

Intervention Type DEVICE

The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.

Interventions

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Virtual Reality Avatar Intervention

In the Virtual Reality Avatar Intervention experience, participants will see an avatar resembling themselves in a park setting.

Intervention Type DEVICE

Virtual Reality Empty Park

The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No