Harnessing Online Peer Education Opioid Study

Sponsor
ElevateU (Industry)
Overall Status
Completed
CT.gov ID
NCT05814315
Collaborator
(none)
67
1
2
5
13.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HOPE Intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Opioid Support and Risk Reduction Online Platform
Actual Study Start Date :
May 1, 2022
Actual Primary Completion Date :
Aug 31, 2022
Actual Study Completion Date :
Sep 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Generalized Anxiety Disorder scale 7 scores [12 weeks]

    Anxiety levels

Secondary Outcome Measures

  1. Beck Depression Inventory scores [12 weeks]

    Depression levels

  2. Current Opioid Misuse Measure scores [12 weeks]

    common opioid misuse measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 ElevateU Corona Del Mar California United States 92625-1243

Sponsors and Collaborators

  • ElevateU

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ElevateU
ClinicalTrials.gov Identifier:
NCT05814315
Other Study ID Numbers:
  • ElevateU
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 14, 2023