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Clinical Trial
. 2014 May 1:138:83-8.
doi: 10.1016/j.drugalcdep.2014.02.002. Epub 2014 Feb 15.

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

Paolo Mannelli  1 , Li-Tzy Wu  2 , Kathleen S Peindl  2 , Marvin S Swartz  2 , George E Woody  2
Affiliations
Clinical Trial

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

Paolo Mannelli et al. Drug Alcohol Depend. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Addiction; Detoxification; Minority recruitment; Opioid agonist; Opioid antagonist; Pharmacotherapy.

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Figures

Figure 1
Figure 1
Mean opioid withdrawal and craving scores during induction and after naltrexone extended release administration (Days 1–9), using SOWS (Subjective Opioid Withdrawal Scale), COWS (Clinical Opioid Withdrawal Scale) and VAS (Visual Analog Scale) for craving. Time point scores are the results of the mean score of each day of treatment, error bars represent +/−1 SEM. Number of participants is reported on the X-axis.
Figure 2
Figure 2
In-treatment proportion of opioid positive urine samples (Day 1–9, N=20)
See this image and copyright information in PMC

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