Behavioral Intervention for Opioid Use Disorder

(HOPE MOUD Trial)

Overseen By Dominic Ugarte

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Unstable substance use, Unstable conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

640 Participants Needed

Trial Summary

What is the purpose of this trial?

In a randomized controlled trial, with 3, 6-month and 1-year follow-up, this application aims to explore whether and how the HOPE intervention can be adapted to increase MOUD uptake among OUD patients, assess the effectiveness of using HOPE to increase MOUD requests, and analyze online community data to improve future intervention implementation and sustainability.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be currently prescribed medications for opioid use disorder (MOUD) to participate.

What data supports the effectiveness of the HOPE Online Support Intervention treatment for opioid use disorder?

Research shows that the HOPE online community can effectively engage patients on opioids to discuss risk reduction strategies, with participants showing higher engagement in discussions about coping and addiction-related topics compared to a control group. This suggests that the HOPE intervention might be a useful tool for supporting individuals with opioid use disorder. ^{1 2 3 4 5}

Is the HOPE Online Support Intervention safe for humans?

The HOPE Online Support Intervention, a social media-based support group, was tested among chronic pain patients on opioid therapy and showed high engagement without reported safety issues, suggesting it is generally safe for humans. ^{1 2 4 6 7}

How is the HOPE Online Support Intervention treatment different from other treatments for opioid use disorder?

The HOPE Online Support Intervention is unique because it uses a social media-based support group to engage patients in discussions about coping strategies and risk reduction, which is different from traditional face-to-face or medication-based treatments. This online community approach allows for higher engagement and peer support among patients, which can be particularly beneficial for those at risk of opioid misuse or overdose. ^{1 3 5 6 8}

Research Team

Sean D Young, PhD

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for adults over 18 living in CA, NV, AZ, OR, WA with moderate to severe opioid use disorder who use social media at least twice a week. Participants must speak English and be willing to create or have a Facebook/social media account to engage with the study's online support group.

Inclusion Criteria

I am not currently taking medication for opioid use disorder.

I speak English.

Resident of CA, NV, AZ, OR, WA

Exclusion Criteria

I'm sorry, I cannot summarize a criterion if it has not been provided. Please provide the criterion you want me to summarize.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group join a peer-led online community on Facebook for 12 weeks

12 weeks

Online participation

Follow-up

Participants are monitored for effectiveness of the intervention with follow-up surveys

12 months

Surveys at 3, 6, and 12 months

Treatment Details

Interventions

• HOPE Online Support Intervention

Trial Overview The HOPE intervention is being tested for its effectiveness in encouraging patients with opioid use disorder to start taking medications designed to treat their condition. The study will follow participants for up to one year and analyze data from an online community.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

HOPE intervention peer-led online community

Group II: Control Active Control 1 Intervention

Online community without HOPE intervention psychological components

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

The HOPE social media-based support group significantly increased patient engagement, with intervention participants making nearly 10 times more posts compared to the control group (411 posts vs. 45).

This online community facilitated discussions on important topics such as coping strategies, pain management, and opioid-related issues, indicating its potential as an effective behavioral intervention for patients at risk of opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a social media/online community support group intervention among chronic pain patients on opioid therapy. Young, SD., Koussa, M., Lee, SJ., et al.[2020]

The pilot study involving 10 adults initiating buprenorphine treatment showed that a web- and text message-based intervention was highly acceptable, with 100% engagement from participants over 8 weeks and a high satisfaction score of 27 out of 30.

Participants reported positive experiences and clinical improvements, suggesting that this digital health intervention could effectively enhance motivation and distress tolerance, potentially leading to better treatment adherence and reduced opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing distress tolerance to uplift motivation in recovery: Results from an open development trial. Bhuptani, PH., Block, A., Jiménez Muñoz, P., et al.[2023]

The OVERCOME study is a randomized clinical trial designed to evaluate the effectiveness of combining computer-based cognitive-behavioral therapy (CBT4CBT) with Recovery Coaching for individuals with opioid use disorder (OUD) who are receiving buprenorphine treatment.

This integrated intervention aims to reduce substance use and improve adherence to buprenorphine, potentially lowering the risk of mortality associated with OUD, as indicated by the study's focus on drug positivity rates and retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale, design, and methodology of a randomized pilot trial of an integrated intervention combining computerized behavioral therapy and recovery coaching for people with opioid use disorder: The OVERCOME study. Pericot-Valverde, I., Perez, A., Heo, M., et al.[2022]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

Digital interventions for treating opioid use disorder, including methods like mobile apps and video conferencing, were found to be generally acceptable and satisfactory to participants, with 10 out of 20 studies showing significant improvements in opioid abstinence.

The effectiveness of these digital interventions varied, with some studies demonstrating better treatment retention, highlighting the need for further research to explore their impact in diverse populations, especially in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions for opioid use disorder treatment: A systematic review of randomized controlled trials. Kiburi, SK., Ngarachu, E., Tomita, A., et al.[2023]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

A personalized psychosocial intervention (PSI) is being tested in a clinical trial with 368 adults over 18 weeks to see if it can improve outcomes for patients with opioid use disorder who are not responding well to standard opioid agonist therapy (OAT).

The primary goal of the trial is to measure the effectiveness of PSI in achieving self-reported abstinence from heroin and cocaine, which will help tailor future treatments for individuals struggling with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of adjunctive, personalised psychosocial intervention for non-response to opioid agonist treatment: Study protocol for a pragmatic randomised controlled trial. Marsden, J., Stillwell, G., Hellier, J., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of a social media/online community support group intervention among chronic pain patients on opioid therapy. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Enhancing distress tolerance to uplift motivation in recovery: Results from an open development trial. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Rationale, design, and methodology of a randomized pilot trial of an integrated intervention combining computerized behavioral therapy and recovery coaching for people with opioid use disorder: The OVERCOME study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Digital interventions for opioid use disorder treatment: A systematic review of randomized controlled trials. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Opioid Overdose Education for Individuals Prescribed Opioids for Pain Management: Randomized Comparison of Two Computer-Based Interventions. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of adjunctive, personalised psychosocial intervention for non-response to opioid agonist treatment: Study protocol for a pragmatic randomised controlled trial. [2022]