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.
Abstract
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.
Type
Journal articleSubject
HumansOpioid-Related Disorders
Substance Withdrawal Syndrome
Buprenorphine
Naltrexone
Narcotic Antagonists
Delayed-Action Preparations
Drug Therapy, Combination
Injections, Intramuscular
Drug Administration Schedule
Adult
Middle Aged
Outpatients
Female
Male
Young Adult
Craving
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https://hdl.handle.net/10161/19976Published Version (Please cite this version)
10.1016/j.drugalcdep.2014.02.002Publication Info
Mannelli, 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.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Paolo Mannelli
Associate Professor of Psychiatry and Behavioral Sciences
Kathleen S. Peindl
Assistant Consulting Professor in the Department of Psychiatry and Behavioral Sciences
Marvin Stanley Swartz
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
Li-Tzy Wu
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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