Enhancing Prospective Thinking in Early Recovery (PARK)

Indiana University

Status and phase: Completed; Early Phase 1

Conditions: Opioid Use Disorder; Substance Use Disorders; Opioid Use

Treatments: Device: Virtual Reality Empty Park; Device: Virtual Reality Avatar Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05908097

PARK (Other Identifier)

1R41DA055405-01 (U.S. NIH Grant/Contract)

1805574553 Aims 7-8;

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Virtual Reality

Experimental group

Description:

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

Treatment:

Device: Virtual Reality Avatar Intervention

Device: Virtual Reality Empty Park

Sham VR (Control)

Sham Comparator group

Description:

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

Treatment:

Device: Virtual Reality Empty Park