Values-Based Intervention for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Victoria Ameral, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Must be taking: Buprenorphine, Methadone, Naltrexone

Disqualifiers: Psychosis, Mania, Suicidality, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The US Veteran community continues to feel the impact of the overdose crisis, and opioid use disorder (OUD) diagnoses among Veterans continue to rise. Medication treatment (e.g., buprenorphine, methadone, naltrexone) helps prevent relapse and reduce overdose risk, but does not help with the psychological, social, and functional challenges of early recovery. Therapies that focus on interpersonal functioning and community integration may help improve quality of life during this high-risk period. This research project will create and test a brief, values-based treatment to help Veterans improve their interpersonal functioning and community integration during early treatment. This study will have three phases. Phase 1 will involve the development of the treatment and adaptation using interviews with Veterans and VA Providers. Phase 2 will test the treatment with a group of 10 Veterans to make sure the treatment can be delivered as intended, and to make changes to the treatment or study procedures based on Veteran feedback. Finally, Phase 3 will test the treatment compared to usual treatment in a pilot randomized controlled trial with a group of 40 Veterans. This final phase will provide additional information about Veterans' experience of the treatment and study procedures and the preliminary effects of the treatment on quality of life and related outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be within 12 weeks of starting buprenorphine, methadone, or naltrexone treatment for opioid use disorder.

What data supports the effectiveness of this drug for opioid use disorder?

Research shows that buprenorphine, especially in its extended-release form, is effective in treating opioid use disorder by improving treatment retention and reducing cravings. Combining buprenorphine with personalized psychosocial interventions can further enhance its effectiveness. ^{1 2 3 4 5}

Is the values-based intervention for opioid use disorder safe for humans?

Buprenorphine, used in various forms for opioid use disorder, generally has a good safety profile with a lower risk of overdose compared to other opioids. However, there are risks associated with misuse, such as tissue damage from improper administration, highlighting the importance of following medical guidance. ^{6 7 8 9 10}

How is the values-based intervention for opioid use disorder using buprenorphine different from other treatments?

This treatment is unique because it combines buprenorphine with a values-based intervention, emphasizing behavioral counseling to enhance motivation and coping skills, which is not typically a focus in standard treatments. It also incorporates a person-centered, low-barrier approach, making it more accessible and integrated into primary care, which can improve patient engagement and retention. ^{3 10 11 12 13}

Research Team

Victoria Ameral, PhD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Eligibility Criteria

This trial is for US Veterans with moderate to severe opioid use disorder who have started buprenorphine treatment in the last 2 weeks after a gap of at least 2 months. Participants must be able to consent and not require hospitalization for suicidality, detoxification for active substance use, or have psychosis, mania, or cognitive impairments that could affect participation.

Inclusion Criteria

I started buprenorphine treatment less than 2 weeks ago after not being treated for over 2 months.

Meets current Diagnostic and Statistical Manual - 5th Edition criteria for moderate to severe opioid use disorder

I am able to understand and sign the consent form.

Exclusion Criteria

I do not have any cognitive issues that would prevent me from participating in the study.

I have been hospitalized for suicidal thoughts or actions.

You are currently using drugs and need to stop using them before participating.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

8-9 months

Interviews with stakeholders

Initial Development

Development of a brief, 4-session values intervention to improve interpersonal functioning and community reintegration during early medication treatment for OUD

13 months

Stakeholder interviews and manual development

Open Pilot

Field test and refine the initial intervention with 10 Veterans in early buprenorphine treatment

14 months

3 assessment and 4 intervention sessions

Pilot RCT

Evaluate the refined intervention and assessment procedures with 40 Veterans, randomized to intervention or treatment as usual

33 months

Assessment sessions at baseline, post-treatment, 3-month, and 6-month follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments

Treatment Details

Interventions

• Brief, values based intervention for early buprenorphine treatment (Behavioral Intervention)
• Treatment as Usual (Behavioral Intervention)

Trial Overview The study is testing a new brief values-based intervention aimed at improving life quality by enhancing interpersonal functioning and community integration during early recovery from opioid dependence. It will be compared against the usual treatment methods in a pilot randomized controlled trial involving initially development and feedback phases.

Participant Groups

Group I: Open Pilot Experimental Treatment 1 Intervention

In Phase 2, all Veterans will receive the active treatment.

Group II: Active Condition Experimental Treatment 1 Intervention

In Phase 3 (Pilot RCT), half of Veterans will be randomly assigned to the active treatment.

Group III: Treatment as Usual Active Control 1 Intervention

In Phase 3 (Pilot RCT), half of Veterans will be randomly assigned to treatment as usual.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

The study investigates the experiences and health-related quality of life of participants receiving monthly, extended-release injectable buprenorphine (BUP-XR) compared to standard treatments like sublingual buprenorphine (BUP-SL) and methadone (MET) in a randomized controlled trial involving multiple centers in the UK.

The research includes mixed-methods evaluations to gather qualitative and quantitative data, aiming to enhance understanding of treatment effectiveness and participant experiences over a 12-24 month period, with a focus on personalized psychosocial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience and response to a randomised controlled trial of extended-release injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone for opioid use disorder: protocol for a mixed-methods evaluation. Lowry, N., Cowden, F., Day, E., et al.[2022]

This trial aims to evaluate the effectiveness of a user-centered clinical decision support (CDS) system in increasing the initiation of buprenorphine (BUP) treatment for individuals with opioid use disorder (OUD) in 20 emergency departments over 18 months.

The primary outcome will measure the rate of BUP initiation in the emergency department, while secondary outcomes will assess referral rates and clinician adherence to the CDS, ensuring a comprehensive evaluation of the intervention's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial. Melnick, ER., Jeffery, MM., Dziura, JD., et al.[2023]

After three years of buprenorphine's approval for office-based treatment of opioid addiction, nearly 90% of addiction specialists were authorized to prescribe it, with two-thirds actively treating patients, indicating strong adoption among specialists.

In contrast, fewer than 10% of non-addiction specialist psychiatrists prescribed buprenorphine, highlighting a significant gap in treatment access and suggesting that organizational support and training are crucial for expanding its use beyond addiction specialists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of buprenorphine for addiction treatment: perspectives of addiction specialists and general psychiatrists. Thomas, CP., Reif, S., Haq, S., et al.[2021]

This study is evaluating the effectiveness and cost-effectiveness of long-acting injectable buprenorphine (BUP-XR) compared to standard opioid treatments (sublingual buprenorphine and oral liquid methadone) in adults with opioid use disorder, involving 304 participants over 24 weeks.

The trial will also assess the impact of adding personalized psychosocial interventions (PSI) to BUP-XR, aiming to determine if this combination leads to better outcomes in terms of abstinence from opioids and overall recovery compared to standard treatments with PSI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-release pharmacotherapy for opioid use disorder (EXPO): protocol for an open-label randomised controlled trial of the effectiveness and cost-effectiveness of injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone. Marsden, J., Kelleher, M., Hoare, Z., et al.[2022]

Buprenorphine is an effective and safe treatment for opioid use disorder, but its initiation often requires patients to be in withdrawal, which can be a barrier to treatment.

Recent changes in prescribing laws and new low-dose induction procedures can enhance the acceptability and retention of buprenorphine treatment in primary care, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A practical guide for buprenorphine initiation in the primary care setting. León-Barriera, R., Zwiebel, SJ., Modesto-Lowe, V.[2023]

In a 12-week study involving patients with chronic low back pain, the Butrans® (buprenorphine) transdermal system at a higher dose (20 μg/h) significantly improved health-related quality of life compared to a lower dose (5 μg/h), particularly in areas like physical health and bodily pain.

The improvements in quality of life for patients receiving the higher dose were not only significant at 12 weeks but also maintained throughout a subsequent 52-week open-label extension phase, indicating long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine transdermal system and quality of life in opioid-experienced patients with chronic low back pain. Miller, K., Yarlas, A., Wen, W., et al.[2022]

Buprenorphine (Subutex) is recognized for its improved safety profile in treating opioid dependence, particularly by reducing the risk of overdose compared to other opioids.

Despite its safety advantages, there are still risks associated with the diversion of buprenorphine for misuse, as evidenced by cases of attempted intravenous injection, highlighting the need for strict dispensing protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Groin tissue necrosis requiring skin graft following parenteral abuse of buprenorphine tablets. Feeney, GF., Fairweather, P.[2013]

A survey of 1174 physicians prescribing buprenorphine revealed that 93.3% believe patients would benefit from formal counseling during treatment, highlighting the perceived importance of psychosocial interventions.

However, only 36.4% of prescribers feel there are enough counselors available in their communities, with significant disparities in resource availability between addiction specialists and primary care providers, indicating a need for improved access to psychosocial support for patients with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived need and availability of psychosocial interventions across buprenorphine prescriber specialties. Lin, LA., Lofwall, MR., Walsh, SL., et al.[2022]

In a study of 845 patients with opioid use disorder (OUD) at California Bridge hospitals, 58% received hospital-administered buprenorphine and 55% received a prescription at discharge, indicating effective access to medication for opioid use disorder in these settings.

Patients with unstable housing were more likely to receive hospital-administered buprenorphine, and those with Medicaid insurance had higher odds of receiving a prescription, suggesting that treatment delivery can be adjusted to better serve individuals facing social and economic disadvantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voting with their feet: Social factors linked with treatment for opioid use disorder using same-day buprenorphine delivered in California hospitals. Kalmin, MM., Goodman-Meza, D., Anderson, E., et al.[2022]

References

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

Experience and response to a randomised controlled trial of extended-release injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone for opioid use disorder: protocol for a mixed-methods evaluation. [2022]

2. England pubmed.ncbi.nlm.nih.gov

User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Systematic content analysis of patient evaluations of START NOW psychotherapy reveals practical strategies for improving the treatment of opioid use disorder. [2021]

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

Use of buprenorphine for addiction treatment: perspectives of addiction specialists and general psychiatrists. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Extended-release pharmacotherapy for opioid use disorder (EXPO): protocol for an open-label randomised controlled trial of the effectiveness and cost-effectiveness of injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone. [2022]

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

A practical guide for buprenorphine initiation in the primary care setting. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Buprenorphine transdermal system and quality of life in opioid-experienced patients with chronic low back pain. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Groin tissue necrosis requiring skin graft following parenteral abuse of buprenorphine tablets. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Addiction Recovery Among Opioid-Dependent Patients Treated With Injectable Subcutaneous Depot Buprenorphine: Study Protocol of a Non-randomized Prospective Observational Study (ARIDE). [2020]

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

"It's a place that gives me hope": A qualitative evaluation of a buprenorphine-naloxone group visit program in an urban federally qualified health center. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Perceived need and availability of psychosocial interventions across buprenorphine prescriber specialties. [2022]

12. Ireland pubmed.ncbi.nlm.nih.gov

Voting with their feet: Social factors linked with treatment for opioid use disorder using same-day buprenorphine delivered in California hospitals. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Behavioral counseling content for optimizing the use of buprenorphine for treatment of opioid dependence in community-based settings: a review of the empirical evidence. [2018]