Implantable Buprenorphine (Probuphine) for Maintenance Treatment of Opioid Use Disorder.
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Abstract:
Implantable buprenorphine is an expensive alternative for patients on a stable dosage of transmucosal buprenorphine. Based on current research and guidance, implantable buprenorphine should not be used as initial treatment for opioid dependence or as a substitute for medication-assisted treatments other than transmucosal buprenorphine.Cite
Importance: Patients with opioid use disorder (OUD) have high hospital admission rates. Hospitalists, clinicians that work in inpatient medical settings, may have a unique opportunity to intervene on behalf of these patients, yet their experience with and attitudes towards treating patients with OUD need further exploration. Objective: To understand hospitalist perspectives and attitudes on treating inpatients with OUD. Design: Qualitative analysis of 22 semi-structured interviews with hospitalists conducted between January and April 2021. Participants were asked about their experiences, successes, and difficulties in treating hospitalized patients with OUD. Setting: Two sites: one major metropolitan university hospital and one urban community hospital in a city with a high prevalence of OUD and overdose deaths. Participants: A convenience sample of hospitalist physicians, nurse practitioners, and physician assistants who practice on general medicine inpatient services were recruited. Main Outcomes and Measures: Perspectives on treating inpatients with OUD, institutional/community/legal barriers to treating OUD, and potential solutions. Results: Twenty-two hospitalists were interviewed. Participants were majority female (14, 64%) and White (16, 73%). We identified the following common themes: lack of training/experience with OUD, a lack of community OUD treatment infrastructure, a lack of inpatient OUD/withdrawal treatment resources, the 'X-waiver' as a barrier to prescribing buprenorphine, the 'ideal' patient to start on buprenorphine, and the hospital as an ideal intervention setting. Conclusions and Relevance: Hospitalization due to acute illness or complication of drug use represents a potential intervention point to initiate treatment for patients with OUD. While hospitalists exhibit willingness to prescribe medications, provide harm reduction education, and link patients to outpatient addiction treatment, they identify training and infrastructure barriers that must first be addressed.
Opiate Substitution Treatment
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Importance
Buprenorphine is an efficacious, widely used treatment for opioid use disorder (OUD). Daily oral transmucosal formulations can be associated with misuse, diversion, and nonadherence; these limitations may be obviated by a sustained release formulation.Objective
To evaluate the ability of a novel, weekly, subcutaneous buprenorphine depot formulation, CAM2038, to block euphorigenic opioid effects and suppress opioid withdrawal in non–treatment-seeking individuals with OUD.Design, Setting, and Participants
This multisite, double-blind, randomized within-patient study was conducted at 3 controlled inpatient research facilities. It involved 47 adults withDSM-Vmoderate-to-severe OUD. The study was conducted from October 12, 2015 (first patient enrolled), to April 21, 2016 (last patient visit).Interventions
A total of five 3-day test sessions evaluated the response to hydromorphone (0, 6, and 18 mg intramuscular in random order; 1 dose/session/day). After the first 3-day session (ie, qualification phase), participants were randomized to either CAM2038 weekly at 24 mg (n = 22) or 32 mg (n = 25); the assigned CAM2038 dose was given twice, 1 week apart (day 0 and 7). Four sets of sessions were conducted after randomization (days 1-3, 4-6, 8-10, and 11-13).Main Outcomes and Measures
The primary end point was maximum rating on the visual analog scale for drug liking. Secondary end points included other visual analog scale (eg, high and desire to use), opioid withdrawal scales, and physiological and pharmacokinetic outcomes.Results
A total of 46 of 47 randomized participants (mean [SD] age, 35.5 [9] years; 76% male [n = 35]) completed the study. Both weekly CAM2038 doses produced immediate and sustained blockade of hydromorphone effects (liking maximum effect, CAM2038, 24 mg: effect size, 0.813;P < .001, and CAM2038, 32 mg: effect size, 0.753;P < .001) and suppression of withdrawal (Clinical Opiate Withdrawal Scale, CAM2038, 24 mg: effect size, 0.617;P < .001, and CAM2038, 32 mg: effect size, 0.751;P < .001). CAM2038 produces a rapid initial rise of buprenorphine in plasma with maximum concentration around 24 hours, with an apparent half-life of 4 to 5 days and approximately 50% accumulation of trough concentration from first to second dose (trough concentration = 0.822 and 1.23 ng/mL for weeks 1 and 2, respectively, with 24 mg; trough concentration = 0.993 and 1.47 ng/mL for weeks 1 and 2, respectively, with 32 mg).Conclusions and Relevance
CAM2038 weekly, 24 and 32 mg, was safely tolerated and produced immediate and sustained opioid blockade and withdrawal suppression. The results support the use of this depot formulation for treatment initiation and stabilization of patients with OUD, with the further benefit of obviating the risk for misuse and diversion of daily buprenorphine while retaining its therapeutic benefits.Trial Registration
Clinicaltrials.gov Identifier:NCT02611752Hydromorphone
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Pharmacodynamics
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Limiting
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Maintenance therapy
Family Therapy
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Opioid use disorder is a growing problem in the United States that can have devastating consequences on affected individuals. Buprenorphine is a partial mu-opioid agonist that can be used in the treatment of opioid dependence. In this article, the pharmacology of buprenorphine is discussed as is the dosing strategy. Formulations and product availability are mentioned and assessed. Several studies comparing the use of buprenorphine to methadone for opioid dependence are briefly reviewed.
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Objective: Opioid use disorder (OUD) is associated with chronic pain. We investigated the association between medication treatments for OUD and pain in a post-hoc secondary analysis of a randomized trial of methadone versus buprenorphine/naloxone. Methods: 1241 individuals with OUD participated in an open label, pragmatic randomized trial of methadone versus buprenorphine/naloxone in nine treatment programs licensed to dispense agonist medication for OUD between 2006 to 2009. In this post-hoc analysis, pain was dichotomized (present or not present) using responses from the Short Form-36. Logistic regression models were fit to test the effect of (1) having baseline pain on week 24 retention, (2) treatment assignment on improvement in pain among those reporting pain at baseline, and (3) pain improvement at week 4 on week 24 retention among those reporting pain at baseline. Results: Almost half (48.2%) of the sample reported pain at baseline. Participants with baseline pain did not significantly differ in week 24 retention compared to those without baseline pain. Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76 [1.10, 2.82], P = 0.020). Conclusion and Relevance: In this large multisite randomized trial of medication treatments for OUD, nearly half of the participants reported pain at baseline, and improvement in pain early in treatment was associated with increased likelihood of retention in treatment.
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Background: Relapse to opioid use is common after rapid opioid withdrawal. As a result, short-term tapers of opioid agonist/partial agonist medications, such as methadone and buprenorphine/naloxone, are no longer recommended by recent clinical care guidelines for the management of opioid use disorder. Nonetheless, rapid tapers are still commonplace in medically supervised withdrawal settings. Case summary: We report a case of an individual with opioid use disorder who was prescribed a rapid buprenorphine/naloxone taper in a medically supervised withdrawal facility and who had a subsequent opioid overdose and death after discharge. Discussion: The fatal outcome in this case study underscores the potential severe harms associated with use of rapid tapers. Given the increased overdose risk, tapers should be avoided and continuing care strategies, such as maintenance pharmacotherapy, should be initiated in medically supervised withdrawal settings.
Opioid Overdose
Opioid-Related Disorders
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Introduction: Opioid use disorder (OUD) has risen globally and is exerting an enormous toll on public health in many countries, particularly in the United States (US). Buprenorphine (BUP) has become one of the mainstays of pharmacological treatment for OUD and newer delivery methods have been developed to improve its effectiveness in treatment. Areas covered: We provide a review of BUP products available for OUD, with a focus on the newer long-acting formulations. A literature search was conducted using PubMed, Google Scholar, and ClinicalTrials.gov to find randomized clinical trials of long-acting BUP products. Four randomized clinical trials were found: two with BUP implant and two with subcutaneous injectable BUP. Expert opinion: In these clinical trials, new BUP formulations were found to be non-inferior to sublingual (SL) BUP and more effective than placebo in reducing opioid use. Longer-acting formulations can improve flexibility in dosing but superiority over existing SL BUP with regards to outcomes needs to be ascertained. There is a need for more comparative studies between longer-acting BUP formulations and currently available SL BUP. Future studies should also include other clinically meaningful outcomes such as quality of life measures, long-term remission rates, and cost-effectiveness.
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Abstract Introduction and Aims Buprenorphine/naloxone is an evidence‐based treatment for opioid use disorder, but an identified limitation is the period of required opioid abstinence prior to induction on the medication. ‘Micro‐dosing’, or using incrementally increasing doses of buprenorphine/naloxone over time, may be a way to overcome this challenge as it can be done in parallel with the ongoing use of other opioids (either illicit or prescribed). Design and Methods A retrospective case series (January to December 2018) was completed of seven participants who underwent buprenorphine/naloxone induction using micro‐dosing at two outpatient addiction clinics in Vancouver, Canada. Results Seven participants completed a 7‐day buprenorphine/naloxone micro‐dosing protocol. Prior to and during the induction, one participant was prescribed methadone, three were prescribed slow release oral morphine and three used only illicit fentanyl. Participants were prescribed sublingual buprenorphine/naloxone: 0.5 mg once daily (day 1), 0.5 mg twice daily (BID; day 2), 1 mg BID (day 3), 2 mg BID (day 4), 3 mg BID (day 5), 4 mg BID (day 6) and 12 mg once daily (day 7). On day 7, all prescribed or illicit full opioid agonists were discontinued. Buprenorphine/naloxone was subsequently titrated to a daily dose of between 12 and 32 mg. All patients reported success with buprenorphine/naloxone induction with no precipitated withdrawal. Discussion and Conclusions Buprenorphine/naloxone micro‐dosing may offer a promising alternative approach for successful induction for individuals with opioid use disorder who desire treatment with buprenorphine/naloxone, and further research to determine effectiveness is warranted.
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