|Titre :||Effect of buprenorphine weekly depot (CAM2038) and hydromorphone blockade in individuals with opioid use disorder: A randomized clinical trial (2017)|
|Auteurs :||S. L. WALSH ; S. D. COMER ; M. R. LOFWALL ; B. VINCE ; N. LEVY-COOPERMAN ; D. KELSH ; M. A. COE ; J. D. JONES ; P. A. NUZZO ; F. TIBERG ; B. SHELDON ; S. KIM|
|Type de document :||Article : Périodique|
|Dans :||JAMA Psychiatry (Vol.74, n°9, September 2017)|
|Article en page(s) :||894-902|
|Discipline :||TRA (Traitement et prise en charge / Treatment and care)|
Thésaurus TOXIBASEETUDE RANDOMISEE ; ETUDE CLINIQUE ; BUPRENORPHINE ; OPIOIDES ; VOIE D'ADMINISTRATION ; VOIE SOUSCUTANEE ; INJECTION ; TRAITEMENT DE MAINTENANCE ; SYNDROME DE SEVRAGE
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 with DSM-V moderate-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  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 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: NCT02611752
Question: Can a novel sustained release buprenorphine weekly injectable formulation (CAM2038) produce robust opioid blockade and opioid withdrawal suppression?
Findings: This randomized clinical trial enrolled individuals with opioid use disorder but not seeking treatment and examined the response to hydromorphone before and after administration of CAM2038 at 2 doses. Both CAM2038 doses produced robust opioid blockade on the primary outcome measure of subjective response for liking of hydromorphone and immediate and sustained withdrawal suppression.
Meaning: Weekly injectable CAM2038 shows promise as a potential treatment for individuals with opioid use disorder.
|Domaine :||Autres substances / Other substances|
|Refs biblio. :||39|
|Affiliation :||Center on Drug and Alcohol Research, University of Kentucky, Lexington, KY, USA|