Medication ComplianceNCT05814315
Harnessing Online Peer Education Opioid Study
A study testing HOPE Intervention in people with Medication Compliance and Pain, run by ElevateU at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Compliance, Pain
- What is being tested?
- HOPE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Medication Compliance, Pain
- Being tested
- HOPE Intervention
- Medical subject headings
- Medication Adherence, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPE InterventionBehavioural
Participants used the Health Checkins Platform for 12 weeks for emotional support and to obtain pain management tools
| Study group | Role | What they receive |
|---|---|---|
| HOPE Intervention | Experimental | These participants will have peer support and online support groups. Receives: Behavioral: HOPE Intervention |
| Control | No intervention | The control will not have any support provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder scale 7 scores
Anxiety levels
Measured: 12 weeks
Secondary outcomes (2)
Beck Depression Inventory scores
Depression levels
Measured: 12 weeks
Current Opioid Misuse Measure scores
common opioid misuse measure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 May 2022
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElevateU
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814315
- Sponsor's protocol ID
- ElevateU
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Support and Risk Reduction Online Platform
- ClinicalTrials.gov ID
- NCT05814315
- Acronym / sponsor ID
- ElevateU
- Conditions
- Medication Compliance, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- ElevateUIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOPE Intervention | Experimental | Behavioral: HOPE InterventionThese participants will have peer support and online support groups. |
| Control | No intervention | –The control will not have any support provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOPE InterventionParticipants used the Health Checkins Platform for 12 weeks for emotional support and to obtain pain management tools | Behavioural | HOPE Intervention |
Primary outcome
Generalized Anxiety Disorder scale 7 scores
Time frame: 12 weeks
Anxiety levels
2 secondary outcomes
Beck Depression Inventory scores
Time frame: 12 weeks
Current Opioid Misuse Measure scores
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Medication Compliance
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Not yet recruitingObservational study
Factors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda
Malaria
Enrolling by invitationObservational study
Heart Rate Variability and Medication Adherence in Resistant Hypertension
Resistant Hypertension, Medication Adherence
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Recruiting
IMB-Guided Health Education Intervention for Medication Adherence and Blood Pressure Control in Non-adherent Hypertensive Patients
Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOPE Intervention in people with Medication Compliance and Pain, run by ElevateU at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder scale 7 scores (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.