search
Back to results

Enhancing Prospective Thinking in Early Recovery (RENTS)

Primary Purpose

Stimulant Use, Substance Use Disorders

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

About this trial

This is an interventional basic science trial for Stimulant Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Abstinence between ≥14 days and ≤1 year At least 18 years old Verbal endorsement of commitment to recovery Outpatient Psychotropic drugs for SUD-comorbidity Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit English comprehension Exclusion Criteria: Unstable medical disorders Less than 18 years old Habitual drug use Mu-opioid drugs Smell/taste disorders Unstable psychiatric conditions Extravagant/elaborate face tattoos

Sites / Locations

  • Indiana University School of Medicine - Goodman HallRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Virtual Reality

Treatment As Usual

Arm Description

Participants in this arm will receive the following interventions: Virtual Reality Park Virtual Reality Avatar

Participants in this arm will receive the following interventions: Virtual Reality Park

Outcomes

Primary Outcome Measures

Reduced Use of Drug Using Days
The Virtual Reality Avatar experience will reduce drug using days.
Increased Length of Abstinence
The Virtual Reality Avatar experience will increase the length of abstinence periods.
Increased (overall) Abstinence
The Virtual Reality Avatar experience will increase abstinence.
Future Self-identification
The Virtual Reality Avatar experience will increase future self-identification.
Future Time Perspective
The Virtual Reality Avatar experience will increase future time perspective.
Delayed Reward Preference
The Virtual Reality Avatar experience will increase preference for delayed rewards.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2023
Last Updated
July 13, 2023
Sponsor
Indiana University
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05835921
Brief Title
Enhancing Prospective Thinking in Early Recovery
Acronym
RENTS
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
March 28, 2023 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
May 1, 2026 (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 use a novel virtual reality intervention to test for efficacy in reducing stimulant use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering stimulant use disorder (StUD) persons. The main question[s] this trial aims to answer are: Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase stimulant drug abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups 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
Stimulant Use, Substance Use Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: Experimental Group Control Group
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
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Participants in this arm will receive the following interventions: Virtual Reality Park Virtual Reality Avatar
Arm Title
Treatment As Usual
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive the following interventions: Virtual Reality Park
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
Both groups will receive a Virtual Reality Park experience, which is an empty park with no avatars. Only the experimental group will have a Virtual Reality Avatar experience, where they will see an avatar resembling themselves in a park setting.
Primary Outcome Measure Information:
Title
Reduced Use of Drug Using Days
Description
The Virtual Reality Avatar experience will reduce drug using days.
Time Frame
Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Title
Increased Length of Abstinence
Description
The Virtual Reality Avatar experience will increase the length of abstinence periods.
Time Frame
Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Title
Increased (overall) Abstinence
Description
The Virtual Reality Avatar experience will increase abstinence.
Time Frame
Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Title
Future Self-identification
Description
The Virtual Reality Avatar experience will increase future self-identification.
Time Frame
Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Title
Future Time Perspective
Description
The Virtual Reality Avatar experience will increase future time perspective.
Time Frame
Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Title
Delayed Reward Preference
Description
The Virtual Reality Avatar experience will increase preference for delayed rewards.
Time Frame
Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Abstinence between ≥14 days and ≤1 year At least 18 years old Verbal endorsement of commitment to recovery Outpatient Psychotropic drugs for SUD-comorbidity Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit English comprehension Exclusion Criteria: Unstable medical disorders Less than 18 years old Habitual drug use Mu-opioid drugs 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 M 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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pre-determined participant 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.

Learn more about this trial

Enhancing Prospective Thinking in Early Recovery

We'll reach out to this number within 24 hrs