Opioid Use — Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
Citation(s)
(2017) USFDA Press Announcements - FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder. 2018.
Drug Enforcement Administration, Department of Justice Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder. Final rule. Fed Regist. 2018 Jan 23;83(15):3071-5.
Fleischauer AT, Ruhl L, Rhea S, Barnes E Hospitalizations for Endocarditis and Associated Health Care Costs Among Persons with Diagnosed Drug Dependence - North Carolina, 2010-2015. MMWR Morb Mortal Wkly Rep. 2017 Jun 9;66(22):569-573. doi: 10.15585/mmwr.mm6622a1.
Jones CM, Campopiano M, Baldwin G, McCance-Katz E National and State Treatment Need and Capacity for Opioid Agonist Medication-Assisted Treatment. Am J Public Health. 2015 Aug;105(8):e55-63. doi: 10.2105/AJPH.2015.302664. Epub 2015 Jun 11.
Kakko J, Svanborg KD, Kreek MJ, Heilig M 1-year retention and social function after buprenorphine-assisted relapse prevention treatment for heroin dependence in Sweden: a randomised, placebo-controlled trial. Lancet. 2003 Feb 22;361(9358):662-8.
Mattick RP, Breen C, Kimber J, Davoli M Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2014 Feb 6;(2):CD002207. doi: 10.1002/14651858.CD002207.pub4. Review.
McLellan AT, Lewis DC, O'Brien CP, Kleber HD Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation. JAMA. 2000 Oct 4;284(13):1689-95. Review.
Park-Lee E, Lipari RN, Hedden SL, Kroutil LA, Porter JD Receipt of Services for Substance Use and Mental Health Issues Among Adults: Results from the 2016 National Survey on Drug Use and Health. In: CBHSQ Data Review. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); September 2017:1-35.
Prevention CfDCa Heroin Overdose Data. US Department of Health and Human Services. https://www.cdc.gov/drugoverdose/data/heroin.html. Published Jan 2017. Updated 2018-08-31T12:47:34Z. Accessed September 3 2018.
Rosenblatt RA, Andrilla CH, Catlin M, Larson EH Geographic and specialty distribution of US physicians trained to treat opioid use disorder. Ann Fam Med. 2015 Jan-Feb;13(1):23-6. doi: 10.1370/afm.1735.
Rudd RA, Aleshire N, Zibbell JE, Gladden RM Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64(50-51):1378-82. doi: 10.15585/mmwr.mm6450a3.
Rudd RA, Seth P, David F, Scholl L Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.
Winchell C Cross-Discipline Team Leader Review and Summary Basis for Approval. In: Administration FD, ed: Federal Drug Administration; 2017.
Yokell MA, Zaller ND, Green TC, Rich JD Buprenorphine and buprenorphine/naloxone diversion, misuse, and illicit use: an international review. Curr Drug Abuse Rev. 2011 Mar;4(1):28-41. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
