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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how emergency departments assist individuals with opioid use disorder by testing a new approach called "Talk About It," a communication-based intervention. The goal is to facilitate patients in starting and adhering to treatments like buprenorphine or methadone, which can lower the risk of death from opioid use. The trial seeks participants who are at least 16 years old, show signs of opioid use disorder (such as withdrawal or overdose), and are not currently on these medications. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for opioid use disorder.

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 prior data suggests that the Talk About It intervention is safe for patients with opioid use disorder?

Research has shown that both buprenorphine and methadone, the medications discussed in the "Talk About It" program, are safe to use. The FDA has approved these treatments for opioid addiction, and they have been proven to lower the risk of death and health problems related to opioid use.

Studies have found that most people tolerate these medications well, though they can have side effects. For instance, buprenorphine might cause nausea or constipation, while methadone could lead to drowsiness or sweating. Serious side effects are rare but can occur, so monitoring by a healthcare provider is important.

The "Talk About It" program aims to start conversations in emergency rooms to help patients begin these treatments. It focuses not only on the medications but also on making it easier for people to access and understand these effective treatment options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

"Talk About It" is unique because it focuses on enhancing conversations around opioid use disorder treatment with buprenorphine and methadone. Unlike standard treatments that primarily emphasize medication management, this approach highlights the importance of communication and patient-provider interactions. Researchers are excited about this method because it has the potential to improve treatment adherence and outcomes by fostering a more supportive and understanding environment for patients. This conversational focus could lead to more personalized care and better long-term recovery success.

What evidence suggests that the "Talk About It" intervention is effective for opioid use disorder?

Research has shown that medications for opioid use disorder (OUD), such as buprenorphine and methadone, effectively lower the risk of death and disability from opioid use. These medications are the best treatments for managing OUD because they reduce cravings and withdrawal symptoms, making it easier for individuals to maintain recovery. The "Talk About It" program in this trial aims to help patients in emergency rooms begin and continue these treatments. Although specific data on this program is limited, a similar method called motivational interviewing has reduced drug misuse and boosted patients' confidence. Overall, using these medications alongside supportive programs appears promising in aiding recovery from opioid addiction. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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