Extended release naltrexone injection is performed in the majority of opioid dependent patients receiving outpatient induction: a very low dose naltrexone and buprenorphine open label trial.
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The approval of extended release injectable naltrexone (XR-NTX; Vivitrol(®)) has introduced a new option for treating opioid addiction, but studies are needed to identify its place within the spectrum of available therapies. The absence of physiological opioid dependence is a necessary and challenging first step for starting XR-NTX. Outpatient detoxification gives poor results and inpatient detoxification is either unavailable or too brief for the physiological effects of opioids to resolve. Here we present findings from an open label study that tested whether the transition from opioid addiction to XR-NTX can be safely and effectively performed in an outpatient setting using very low dose naltrexone and buprenorphine.Twenty treatment seeking opioid addicted individuals were given increasing doses of naltrexone starting at 0.25mg with decreasing doses of buprenorphine starting at 4 mg during a 7-day outpatient XR-NTX induction procedure. Withdrawal discomfort, craving, drug use, and adverse events were assessed daily until the XR-NTX injection, then weekly over the next month.Fourteen of the 20 participants received XR-NTX and 13 completed weekly assessments. Withdrawal, craving, and opioid or other drug use were significantly lower during induction and after XR-NTX administration compared with baseline, and no serious adverse events were recorded.Outpatient transition to XR-NTX combining upward titration of very low dose naltrexone with downward titration of low dose buprenorphine was safe, well tolerated, and completed by most participants. Further studies with larger numbers of subjects are needed to see if this approach is useful for naltrexone induction.
Substance Withdrawal Syndrome
Drug Therapy, Combination
Drug Administration Schedule
Published Version (Please cite this version)10.1016/j.drugalcdep.2014.02.002
Publication InfoMannelli, Paolo; Wu, Li-Tzy; Peindl, Kathleen S; Swartz, Marvin S; & Woody, George E (2014). Extended release naltrexone injection is performed in the majority of opioid dependent patients receiving outpatient induction: a very low dose naltrexone and buprenorphine open label trial. Drug and alcohol dependence, 138(1). pp. 83-88. 10.1016/j.drugalcdep.2014.02.002. Retrieved from https://hdl.handle.net/10161/19976.
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Associate Professor of Psychiatry and Behavioral Sciences
Assistant Consulting Professor in the Department of Psychiatry and Behavioral Sciences
Professor of Psychiatry and Behavioral Sciences
My major research interest is in examining the effectiveness of services for severely mentally ill individuals, including factors that improve or impede good outcomes. Current research includes: the effectiveness of involuntary outpatient commitment, psychiatric advance directives, criminal justice outcomes for persons with mental illnesses, violence and mental illness and antipsychotic medications. I also served as member of the MacArthur Foundation Research Network on Mandate
Professor in Psychiatry and Behavioral Sciences
Education/Training: Pre- and post-doctoral training in mental health service research, psychiatric epidemiology (NIMH T32), and addiction epidemiology (NIDA T32) from Johns Hopkins University School of Public Health (Maryland); Fellow of the NIH Summer Institute on the Design and Conduct of Randomized Clinical Trials.Director: Duke Community Based Substance Use Disorder Research Program.Research interests: COVID-19, Opioid misuse, Opioid overdose, Opioid use disorder
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