Values-Based Intervention for Opioid Use Disorder

Overseen By Anne Marie Hernon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Buprenorphine, Methadone, Naltrexone

Disqualifiers: Psychosis, Mania, Suicidality, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans with opioid use disorder (OUD) in the early stages of treatment. It will test a new values-based therapy designed to enhance social connections and community involvement, potentially boosting quality of life. The study will first develop and refine the treatment, then test it with a small group, and finally compare it to standard care in a larger group. Veterans diagnosed with moderate to severe OUD who have started medication treatment, such as buprenorphine, within the past 12 weeks may be eligible to participate. As an unphased trial, this study offers Veterans the chance to contribute to innovative treatment approaches that could enhance their recovery journey.

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 prior data suggests that this values-based intervention is safe for Veterans with opioid use disorder?

Research has shown that buprenorphine is generally easy for people to take when treating opioid addiction. It helps prevent relapses and lowers the risk of overdose. Studies have found that combining buprenorphine with other supportive treatments can lead to better patient outcomes. Direct information on the safety of the new values-based approach alone is not yet available. However, since this trial focuses on developing and testing this approach, researchers continue to assess its safety. Participant feedback is crucial to ensure the treatment is administered smoothly and safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the values-based intervention for opioid use disorder because it focuses on aligning treatment with patients' personal values and goals, which could enhance motivation and engagement. Unlike standard treatments such as methadone or buprenorphine alone, this approach integrates psychological support early in treatment, potentially improving adherence and outcomes. In addition, it offers a personalized method that addresses the root causes of addiction beyond just managing physical symptoms.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that medications like buprenorphine and methadone effectively treat opioid use disorder (OUD). They reduce the risk of overdose and the need for emergency care. However, these medications do not fully address the social and emotional challenges during recovery. In this trial, some participants will receive a brief, values-based intervention alongside early buprenorphine treatment. This intervention focuses on improving relationships and connecting individuals with their communities, aiming to enhance the quality of life for those in early recovery. Other participants will receive treatment as usual, serving as a comparison to evaluate the effectiveness of the values-based intervention. ^{1 6 7 8 9}

Who Is on the Research Team?

Victoria Ameral, PhD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Brief, values based intervention for early buprenorphine treatment
• Treatment as Usual

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.

How Is the Trial Designed?

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.

Brief, values based intervention for early buprenorphine treatment is already approved in United States, European Union for the following indications:

Approved in United States as Buprenorphine for:

• Severe pain
• Opioid use disorder

Approved in European Union as Buprenorphine for:

• Severe pain
• Opioid dependence

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A study involving 44 patients undergoing buprenorphine/naloxone treatment for opioid use disorder (OUD) found that participation in the START NOW psychotherapy program led to improved satisfaction and positive behavioral trends among participants.

Focus group discussions revealed that patients preferred psychotherapies that address impulsivity, future planning, and relationship building, indicating specific areas for enhancing psychotherapy in OUD treatment.

NCBI (Pubmed)

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. Truong, AY., Saway, BF., Bouzaher, MH., et al.[2021]

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]

Buprenorphine is effective in treating opioid dependence, but its success is significantly enhanced when combined with appropriate behavioral counseling, as shown by decades of research in community-based settings in the U.S.

To optimize buprenorphine treatment, behavioral counseling should focus on boosting patients' motivation at the start of treatment and then shift to developing coping and relapse prevention skills during the primary treatment phase.

NCBI (Pubmed)

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. Copenhaver, MM., Bruce, RD., Altice, FL.[2018]

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 evaluates the impact of once-weekly or once-monthly injectable depot buprenorphine on the quality of life of patients undergoing opioid substitution treatment (OST) in Germany, involving 426 participants matched for various factors to ensure comparability.

The primary outcome will assess changes in quality of life over 12 months using a specific scale, with secondary outcomes including illicit substance use and social participation, aiming to provide comprehensive insights into the recovery process for patients using depot buprenorphine.

NCBI (Pubmed)

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). Schulte, B., Lehmann, K., Schmidt, CS., et al.[2020]

The low-threshold group-based MOUD program at a federally qualified health center in Philadelphia effectively increased patient access and retention through its person-centered harm reduction approach and integration into primary care.

Challenges included varying staff acceptance of harm reduction principles and the need to manage clinic workflow, highlighting the importance of understanding both strengths and challenges for similar programs in other clinics.

NCBI (Pubmed)

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. Lai, S., Li, E., Silverio, A., et al.[2022]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05189223

A Brief Values Intervention to Support Veterans in Early ... Within 12 weeks of initiating buprenorphine, methadone, or naltrexone treatment for opioid use disorder following at least 2 months without treatment ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK458653/

Evidence on Strategies for Addressing the Opioid Epidemic The purpose of this chapter is to review available evidence on strategies that have been used to address the problems of opioid misuse, OUD, and related deaths.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2760032

Comparative Effectiveness of Different Treatment Pathways ... Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772724624000192

The effect of a pilot brief educational intervention on ... A 5-minute intervention can increase preference for MOUD. Individuals with low opioid familiarity were most likely to change their preference towards MOUD.

5. nam.edu nam.edu/perspectives/improving-access-to-evidence-based-medical-treatment-for-opioid-use-disorder-strategies-to-address-key-barriers-within-the-treatment-system/

Improving Access to Evidence-Based Medical Treatment ... Methadone, buprenorphine, and extended-release naltrexone are safe and effective FDA-approved treatments for OUD. People treated with opioid ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6585403/

Buprenorphine Treatment for Opioid Use Disorder We provide a review of the use of buprenorphine for treatment of opioid use disorder and discuss barriers, challenges, risks, and the efficacy of buprenorphine ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8666102/

Safety and efficacy of a prescription digital therapeutic as ... A prescription digital therapeutic in combination with buprenorphine therapy improves clinically significant patient outcomes including abstinence from illicit ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02586896?term=NCT02586896&rank=1

Comparing Interventions for Opioid Dependent Patients ... "Successful outcome" will be defined as 1) 3-month urine negative for opioids (opiates, oxycodone, methadone, buprenorphine, or propoxyphene) unless prescribed ...

9. belbuca.com belbuca.com/hcp/efficacy-safety/

Clinical Efficacy in Severe and Persistent Pain Management The efficacy and safety of BELBUCA in opioid-experienced patients were evaluated in a multicenter, double-blind, placebo-controlled, enriched-enrollment ...