Effectiveness of Injectable Extended-Release Naltrexone vs Daily Buprenorphine-Naloxone for Opioid Dependence: A Randomized Clinical Noninferiority Trial.
Lars Tanum,Lars Tanum,Kristin Klemmetsby Solli,Zill-E-Huma Latif,Jūratė Šaltytė Benth,Jūratė Šaltytė Benth,Arild Opheim,Arild Opheim,Kamni Sharma-Haase,Peter Krajci,Nikolaj Kunøe +10 more
TLDR
In this paper, a 12-week randomized clinical trial was conducted to determine whether treatment with extended-release naltrexone will be as effective as daily buprenorphine hydrochloride with naloxone Hydrochloride in maintaining abstinence from heroin and other illicit substances in newly detoxified individuals.Abstract:
Importance To date, extended-release naltrexone hydrochloride has not previously been compared directly with opioid medication treatment (OMT), currently the most commonly prescribed treatment for opioid dependence. Objective To determine whether treatment with extended-release naltrexone will be as effective as daily buprenorphine hydrochloride with naloxone hydrochloride in maintaining abstinence from heroin and other illicit substances in newly detoxified individuals. Design, Setting and Participants A 12-week, multicenter, outpatient, open-label randomized clinical trial was conducted at 5 urban addiction clinics in Norway between November 1, 2012, and December 23, 2015; the last follow-up was performed on October 23, 2015. A total of 232 adult opioid-dependent (per DSM-IV criteria) individuals were recruited from outpatient addiction clinics and detoxification units and assessed for eligibility. Intention-to-treat analyses of efficacy end points were performed with all randomized participants. Interventions Randomization to either daily oral flexible dose buprenorphine-naloxone, 4 to 24 mg/d, or extended-release naltrexone hydrochloride, 380 mg, administered intramuscularly every fourth week for 12 weeks. Main Outcomes and Measures Primary end points (protocol) were the randomized clinical trial completion rate, the proportion of opioid-negative urine drug tests, and number of days of use of heroin and other illicit opioids. Secondary end points included number of days of use of other illicit substances. Safety was assessed by adverse event reporting. Results Of 159 participants, mean (SD) age was 36 (8.6) years and 44 (27.7%) were women. Eighty individuals were randomized to extended-release naltrexone and 79 to buprenorphine-naloxone; 105 (66.0%) completed the trial. Retention in the extended-release naltrexone group was noninferior to the buprenorphine-naloxone group (difference, −0.1; with 95% CI, −0.2 to 0.1; P = .04), with mean (SD) time of 69.3 (25.9) and 63.7 (29.9) days, correspondingly ( P = .33, log-rank test). Treatment with extended-release naltrexone showed noninferiority to buprenorphine-naloxone on group proportion of total number of opioid-negative urine drug tests (mean [SD], 0.9 [0.3] and 0.8 [0.4], respectively, difference, 0.1 with 95% CI, −0.04 to 0.2; P P P Conclusions and Relevance Extended-release naltrexone was as effective as buprenorphine-naloxone in maintaining short-term abstinence from heroin and other illicit substances and should be considered as a treatment option for opioid-dependent individuals. Trial Registration clinicaltrials.gov Identifier:NCT01717963read more
Citations
More filters
Journal ArticleDOI
Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial.
Joshua D. Lee,Edward V. Nunes,Patricia Novo,Ken Bachrach,Genie L. Bailey,Snehal Bhatt,Sarah Farkas,Marc Fishman,Phoebe Gauthier,Candace C. Hodgkins,Jacquie King,Robert Lindblad,David Liu,Abigail G. Matthews,Jeanine May,K Michelle Peavy,Stephen Ross,Dagmar Salazar,Paul Schkolnik,Dikla Shmueli-Blumberg,D. Stablein,Geetha Subramaniam,John Rotrosen +22 more
TL;DR: It is more difficult to initiate patients to XR-NTX than BUP-NX, and this negatively affected overall relapse, but once initiated, both medications were equally safe and effective.
Journal ArticleDOI
Prevention and Treatment of Opioid Misuse and Addiction: A Review.
TL;DR: The factors that triggered the opioids crisis and its further evolution are analyzed, along with the interventions to manage and prevent opioid use disorder (OUD), which are fundamental for curtailing the opioid crisis.
Journal ArticleDOI
Management of opioid use disorder in the USA: present status and future directions.
Carlos Blanco,Nora D. Volkow +1 more
TL;DR: There is an urgent need for expanding the use of medications for opioid use disorder, including training of health-care professionals in the treatment and prevention of opioid use Disorder, and for development of alternative medications and new models of care to expand capabilities for personalised interventions.
Journal ArticleDOI
Association of Opioid Agonist Treatment With All-Cause Mortality and Specific Causes of Death Among People With Opioid Dependence: A Systematic Review and Meta-analysis.
Thomas Santo,Brodie Clark,Matthew Hickman,Jason Grebely,Gabrielle Campbell,Gabrielle Campbell,Luis Sordo,Aileen Chen,Aileen Chen,Lucy Thi Tran,Chrianna Bharat,Prianka Padmanathan,Gráinne Cousins,Julie Dupouy,Erin Kelty,Roberto Muga,Bohdan Nosyk,Bohdan Nosyk,Jeong Min,Raimondo Maria Pavarin,Michael Farrell,Louisa Degenhardt +21 more
TL;DR: In this article, a systematic review and meta-analysis on the relationship between Opioid agonist treatment (OAT) and specific causes of mortality was conducted. But the authors did not find a significant association between time receiving OAT and mortality.
Journal ArticleDOI
Policy Pathways to Address Provider Workforce Barriers to Buprenorphine Treatment.
TL;DR: Policy pathways to addressing provider workforce barriers going forward include providing free and easy-to-access education for providers about opioid use disorders and medication- assisted treatment, eliminating buprenorphine waiver requirements for those licensed to prescribe controlled substances, enforcing insurance parity requirements, requiring coverage of evidence-based medication-assisted treatment as essential health benefits, and providing financial incentives for care coordination.
References
More filters
Journal Article
The Mini-International Neuropsychiatric Interview (M.I.N.I.) : The development and validation of a Structured Diagnostic Psychiatric Interview for DSM-IV and ICD-10
David V. Sheehan,Yves Lecrubier,Kathy Harnett Sheehan,P. Amorim,J. Janavs,Emmanuelle Weiller,T. Hergueta,Ross A. Baker,Dunbar Geoffrey Charles +8 more
TL;DR: The Mini-International Neuropsychiatric Interview is designed to meet the need for a short but accurate structured psychiatric interview for multicenter clinical trials and epidemiology studies and to be used as a first step in outcome tracking in nonresearch clinical settings.
Journal ArticleDOI
Validation of the Insomnia Severity Index as an outcome measure for insomnia research
TL;DR: The clinical validation of the Insomnia Severity Index (ISI) indicates that the ISI is a reliable and valid instrument to quantify perceived insomnia severity and is likely to be a clinically useful tool as a screening device or as an outcome measure in insomnia treatment research.
Journal ArticleDOI
The Hopkins Symptom Checklist (HSCL): A self-report symptom inventory
TL;DR: The historical evolution, development, rationale and validation of the Hopkins Symptom Checklist is described, a self-report symptom inventory comprised of 58 items which are representative of the symptom configurations commonly observed among outpatients.
Journal ArticleDOI
The fifth edition of the addiction severity index
A. Thomas McLellan,Harvey Kushner,David S. Metzger,Roger H. Peters,Iris E. Smith,Grant R. Grissom,Helen M. Pettinati,Milton Argeriou +7 more
TL;DR: The clinical and research uses of the ASI over the past 12 years are discussed, emphasizing some special circumstances that affect its administration.
Book ChapterDOI
Timeline Follow-Back A Technique for Assessing Self-Reported Alcohol Consumption
Linda C. Sobell,Mark B. Sobell +1 more
TL;DR: Concerns about how best to measure drinking patterns and problems date back to at least 1926, when Pearl stressed the importance of separating steady daily drinkers from occasional heavy drinkers.
Related Papers (5)
Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial.
Joshua D. Lee,Edward V. Nunes,Patricia Novo,Ken Bachrach,Genie L. Bailey,Snehal Bhatt,Sarah Farkas,Marc Fishman,Phoebe Gauthier,Candace C. Hodgkins,Jacquie King,Robert Lindblad,David Liu,Abigail G. Matthews,Jeanine May,K Michelle Peavy,Stephen Ross,Dagmar Salazar,Paul Schkolnik,Dikla Shmueli-Blumberg,D. Stablein,Geetha Subramaniam,John Rotrosen +22 more