Harnessing Online Peer Education Opioid Study

April 13, 2023 updated by: ElevateU

Opioid Support and Risk Reduction Online Platform

The investigators have created an online peer support platform for chronic pain patients on opioid medications. This platform provides peer support and online mental health counselor run support groups to help participants manage pain and not abuse opioid medications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study determined the feasibility, acceptability, and preliminary efficacy of an online support and risk reduction platform to prevent opioid misuse and abuse. This is an urgent area of research; opioid misuse/abuse has reached epidemic proportions in recent years. It is linked to causing the largest drug epidemic in the history of the United States and has become the top priority of the US Surgeon General. Because the opioid crisis (including heroin use) is believed to have largely originated from chronic pain patients' opioid prescriptions, this application will initially focus on the needs of chronic pain patients on opioids who are high risk for addiction and overdose. Later versions of the technology will expand to the broader population of people affected by the opioid crisis, including heroin users.

Although low cost, novel interventions are needed to reduce opioid misuse and abuse, before they lead to addiction and fatal overdose, only 6 behavioral (non-pharmacological) randomized controlled trials have been successfully conducted in this area to date (with our group having conducted one of them), creating a tremendous need for solutions to the opioid crisis. Building off extensive preliminary research that our team conducted, including piloting technology-based behavior change interventions among chronic pain patients, and developing artificial intelligence (AI)-based prediction models of opioid outcomes, we propose to design and test the feasibility, acceptability, and preliminary efficacy of an online peer social support and clinical counseling community to reduce opioid misuse/abuse among chronic pain sufferers.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Corona Del Mar, California, United States, 92625-1243
        • ElevateU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: adults over 18, COMM scores at risk of misuse, prescribed opioids by doctor -

Exclusion Criteria: cancer patients, elicit drug users, under 18 years

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HOPE Intervention
These participants will have peer support and online support groups.
Behavioral: HOPE Intervention
Participants used the Health Checkins Platform for 12 weeks for emotional support and to obtain pain management tools
No Intervention: Control
The control will not have any support provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder scale 7 scores
Time Frame: 12 weeks
Anxiety levels
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory scores
Time Frame: 12 weeks
Depression levels
12 weeks
Current Opioid Misuse Measure scores
Time Frame: 12 weeks
common opioid misuse measure
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ElevateU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ElevateU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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