Buprenorphine & Methadone Conversations for Opioid Use Disorder

(TalkAboutIt Trial)

Overseen By Elizabeth Schoenfeld, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baystate Medical Center

Must not be taking: Buprenorphine, Methadone

Disqualifiers: No opioid use disorder

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-18 months

75 Participants Needed

Trial Summary

What is the purpose of this trial?

The increasing morbidity and mortality of the opioid epidemic has necessitated a reevaluation of current addiction treatment paradigms: medications for opioid use disorder, such as buprenorphine and methadone, are effective in decreasing one's risk of death and disability from opioid use, but are underutilized and often difficult to access. The 5000 Emergency Departments (EDs) in the US are potential additional locales for medication initiation, but currently only a small minority of ED patients with opioid use disorder are started on medications. This study will refine and pilot an intervention called Talk About It which aims to foster patient-centered care, 'meet patients where they are' for addiction treatment, and increase treatment initiation and adherence via facilitating Shared Decision-Making in the ED around these potentially life-saving options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on buprenorphine or methadone in the past 7 days to participate.

What data supports the effectiveness of the treatment Talk About It for opioid use disorder?

Research shows that medication-assisted treatment with buprenorphine or methadone is effective for opioid use disorder, especially when combined with behavioral interventions. Although specific elements of psychotherapy are not clearly defined, patient feedback suggests that combining medication with therapy can improve treatment outcomes. ^{1 2 3 4 5}

Is buprenorphine safe for treating opioid use disorder?

Buprenorphine is generally considered safe for treating opioid use disorder, with studies showing a high safety profile and good tolerance. However, there have been reports of heart-related issues like arrhythmia (irregular heartbeat) and some concerns about misuse, especially when combined with naloxone. ^{6 7 8 9 10}

How is the treatment 'Talk About It' for opioid use disorder different from other treatments?

The treatment 'Talk About It' is unique because it involves conversations about buprenorphine and methadone, which are medications used to treat opioid use disorder. Buprenorphine is a partial agonist with a better safety profile, while methadone is a full agonist. This treatment may focus on discussing these differences and their implications for patients. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for individuals with Opioid Use Disorder. It's focused on those who visit Emergency Departments and could benefit from starting medication treatments like buprenorphine or methadone to manage their condition.

Inclusion Criteria

I am 16 or older and need medication to treat opioid addiction but haven't used buprenorphine or methadone in the last week.

Exclusion Criteria

No Opioid Use Disorder (OUD)

Already on MOUD

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Training

Clinicians are trained to use the 'Talk About It' intervention to facilitate shared decision-making in the ED

0-12 months

Training sessions

Treatment

Participants receive the 'Talk About It' intervention to initiate methadone and buprenorphine treatment

6-18 months

Follow-up

Participants are monitored for treatment adherence and patient-reported outcomes

24 months

Treatment Details

Interventions

• Talk About It

Trial Overview The study tests 'Talk About It', an intervention designed to encourage Shared Decision-Making in the ED, aiming to increase patient-centered care and the initiation of medications for opioid use disorder treatment.

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Recruited

44,500+

Findings from Research

In a study of 100 patients seeking buprenorphine treatment for opioid use disorder, 60% dropped out before starting medication, primarily before the nurse visit, highlighting a significant engagement issue in treatment initiation.

Patients with recent polysubstance use or a history of prior substance use treatments were significantly less likely to successfully reach induction, suggesting that these factors may require targeted support to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking patients with buprenorphine treatment in primary care: Predictors of engagement. Simon, CB., Tsui, JI., Merrill, JO., et al.[2018]

A collaborative care model for treating pregnant patients with opioid use disorder using buprenorphine was shown to be feasible, with 93.8% of pregnancies continuing treatment until delivery.

Most infants (80%) required NICU admission for monitoring or treatment of neonatal abstinence syndrome, highlighting the need for ongoing research to enhance outcomes for mothers and their babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of collaborative care treatment of opioid use disorders with buprenorphine during pregnancy. Mittal, L., Suzuki, J.[2018]

Buprenorphine implants were found to be noninferior to daily sublingual buprenorphine in maintaining opioid abstinence over a 6-month period, with 85.7% of implant users remaining abstinent compared to 71.9% of those on sublingual treatment.

The study involved 177 participants and showed that both treatment methods had similar response rates, but the implant group experienced fewer non-implant-related adverse events, suggesting a potentially safer option for long-term maintenance treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial. Rosenthal, RN., Lofwall, MR., Kim, S., et al.[2016]

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 will involve 280 adults with opioid use disorder and aims to improve adherence to buprenorphine-naloxone treatment through two psychological interventions: contingency management (CM) and brief motivational interviewing plus substance-free activities and mindfulness (BSM).

The primary goal is to assess which intervention is more effective in promoting medication adherence, measured by attendance at physician appointments and the presence of buprenorphine in urine toxicology, with follow-up occurring 8 months after randomization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder. Peter, SC., Murphy, JG., Witkiewitz, K., et al.[2023]

Buprenorphine treatment for pregnant women with opioid use disorder is associated with a lower risk of preterm birth and results in greater birth weight and larger head circumference compared to methadone, based on a review of 18 studies involving 2,146 participants.

There were no significant differences in rates of fetal death or congenital anomalies between the two treatments, suggesting that buprenorphine does not pose greater risks than methadone for these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine compared with methadone to treat pregnant women with opioid use disorder: a systematic review and meta-analysis of safety in the mother, fetus and child. Zedler, BK., Mann, AL., Kim, MM., et al.[2023]

A 12-month study involving 384 opioid-dependent patients in Germany showed that buprenorphine-naloxone is highly effective and safe, with low rates of serious adverse events (1.2%) and no reported deaths.

The treatment led to significant improvements in mental health and quality of life, with a 57.1% retention rate, and 96.7% of patients who remained in treatment continued with buprenorphine-naloxone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, effectiveness and tolerance of buprenorphine-naloxone in the treatment of opioid dependence: results from a nationwide non-interventional study in routine care. Apelt, SM., Scherbaum, N., Gölz, J., et al.[2015]

In a study analyzing adverse events reported to the FDA from 1969 to 2011, methadone was associated with a significantly higher rate of cardiac arrhythmias and QTc prolongation compared to buprenorphine, with 11.6% of methadone cases reporting ventricular arrhythmia/cardiac arrest versus only 1.8% for buprenorphine.

The analysis indicated that methadone had a proportional reporting ratio (PRR) of 7.20 for ventricular arrhythmia/cardiac arrest and 10.7 for QTc prolongation/torsade de pointes, suggesting a strong association, while buprenorphine showed no significant association, highlighting potential safety differences between the two medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arrhythmia associated with buprenorphine and methadone reported to the Food and Drug Administration. Kao, DP., Haigney, MC., Mehler, PS., et al.[2022]

Buprenorphine has been shown to be a safe and effective treatment for opioid dependence, demonstrating low potential for abuse and the ability to reduce heroin use in patients.

Clinical trials comparing buprenorphine to methadone and placebo confirmed its efficacy, with key outcomes including improved retention in treatment and reduced cravings, establishing it as a viable alternative for managing opioid addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of buprenorphine: comparisons to methadone and placebo. Ling, W., Wesson, DR.[2019]

Increasing access to buprenorphine, a treatment for opioid use disorder, is crucial for reducing overdose deaths, but limited availability of buprenorphine monoproduct is a significant barrier.

The requirement to prescribe buprenorphine as a combination product with naloxone may lead to adverse effects that are more serious than previously thought, potentially harming the patient-provider relationship and increasing stigma, which can hinder access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? Gregg, J., Hartley, J., Lawrence, D., et al.[2023]

A recent study involving 1269 participants found that while methadone treatment led to better retention in the program, buprenorphine treatment resulted in a greater reduction in illicit opioid use during the early stages of treatment.

Both buprenorphine and methadone significantly decreased risky behaviors related to HIV, such as needle sharing and having multiple sexual partners, indicating improvements in overall health and safety for individuals undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication-assisted treatment for opioid addiction: methadone and buprenorphine. Saxon, AJ., Hser, YI., Woody, G., et al.[2021]

Patients with opioid use disorder, particularly those on buprenorphine or methadone, present unique challenges in perioperative management due to the distinct pharmacological properties of these medications.

This review aims to consolidate existing research to offer guidance on effectively managing acute pain in patients with opioid use disorder during the perioperative period, ensuring their recovery is not compromised.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Management of Patients on Buprenorphine and Methadone: A Narrative Review Sritapan, Y., Clifford, S., Bautista, A.[2021]

A case report involving one patient showed that a rapid microinduction protocol for transitioning from methadone to buprenorphine was successful without causing precipitated withdrawal, indicating a safer method for patients with opioid use disorder.

This outpatient approach not only proved feasible but also cost-effective, suggesting it could help reduce barriers to adherence in opioid agonist therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Transition From Methadone to Buprenorphine Utilizing a Micro-dosing Protocol in the Outpatient Veteran Affairs Setting. De Aquino, JP., Fairgrieve, C., Klaire, S., et al.[2022]

A study analyzing 900 tweets revealed that discussions about methadone and buprenorphine-naloxone (Suboxone®) primarily focused on access, stigma, and treatment for opioid use disorder (OUD), with only a small percentage expressing positive sentiments about these effective treatments.

Despite the proven efficacy of methadone and Suboxone® in treating OUD, public dialogue on Twitter showed limited recognition of their benefits, which may contribute to their underutilization in addressing the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methadone and suboxone® mentions on twitter: thematic and sentiment analysis. Chenworth, M., Perrone, J., Love, JS., et al.[2023]

In a study of 183 patients with opioid use disorder undergoing major surgery, 66% experienced a perioperative hold on their buprenorphine dose, which is contrary to emerging clinical recommendations.

Despite the high rate of dose holds, 67% of patients remained on buprenorphine one year post-surgery, but there were concerning outcomes, including a 5.5% overdose rate and an 8.2% mortality rate, highlighting the need for better management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Management of Buprenorphine/Naloxone in a Large, National Health Care System: a Retrospective Cohort Study. Wyse, JJ., Herreid-O'Neill, A., Dougherty, J., et al.[2023]

References

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Linking patients with buprenorphine treatment in primary care: Predictors of engagement. [2018]

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

Feasibility of collaborative care treatment of opioid use disorders with buprenorphine during pregnancy. [2018]

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

Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial. [2016]

4. 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]

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

Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder. [2023]

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

Buprenorphine compared with methadone to treat pregnant women with opioid use disorder: a systematic review and meta-analysis of safety in the mother, fetus and child. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety, effectiveness and tolerance of buprenorphine-naloxone in the treatment of opioid dependence: results from a nationwide non-interventional study in routine care. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Arrhythmia associated with buprenorphine and methadone reported to the Food and Drug Administration. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Clinical efficacy of buprenorphine: comparisons to methadone and placebo. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? [2023]

11. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Medication-assisted treatment for opioid addiction: methadone and buprenorphine. [2021]

12. Turkey pubmed.ncbi.nlm.nih.gov

Perioperative Management of Patients on Buprenorphine and Methadone: A Narrative Review [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Rapid Transition From Methadone to Buprenorphine Utilizing a Micro-dosing Protocol in the Outpatient Veteran Affairs Setting. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Methadone and suboxone® mentions on twitter: thematic and sentiment analysis. [2023]

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

Perioperative Management of Buprenorphine/Naloxone in a Large, National Health Care System: a Retrospective Cohort Study. [2023]