Clinical trial NCT05908097: Enhancing Prospective Thinking in Early Recovery (PARK)
Official title: Enhancing Prospective Thinking in Early Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use
Opioid Use Disorder
Substance Use Disorders
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: Experimental and Control
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Reduced Use of Drug Using Days
timeFrame: Study Day Visit; 30-day Follow-up Visit.
measure: Increased Length of Abstinence
timeFrame: Study Day Visit (Day 1); 30-day Follow-up Visit.
measure: Change in Overall Abstinence
timeFrame: Study Day Visit (Day 1); 30-day Follow-up Visit.
measure: Future Self-Identification
timeFrame: Study Day Visit (Day 1); 30-day Follow-up Visit
measure: Future Time Orientation
timeFrame: Study Day Visit (Day 1); 30-day Follow-up Visit.
measure: Delayed Reward
timeFrame: Study Day Visit (Day 1); 30-day Follow-up Visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine - Goodman Hall
state: Indiana
city: Indianapolis
country: United States
facility: IUSM - Goodman Hall
state: Indiana
Study officials:
affiliation: Indiana University
name: Brandon G Oberlin, PhD
role: PRINCIPAL_INVESTIGATOR
References: