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Very low dose naltrexone in opioid detoxification: a double-blind, randomized clinical trial of efficacy and safety

  • Reza Afshari
  • Majid Khadem-RezaiyanEmail author
  • Hoda Khatibi Moghadam
  • Mahdi Talebi
Original Article

Abstract

Withdrawal syndrome is one of the initial focuses of opioid detoxification. Very low dose naltrexone (VLNTX) has been found to reduce opioid tolerance and dependence in animal and human clinical studies. The aim of this study was to determine the safety and efficacy of VLNTX during early stages of detoxification. In a multi-arm parallel, double-blind, randomized controlled trial, 63 opioid-dependent male participants referring to Imam Reza Rehabilitation Center were allocated to three equal groups using block randomization method. They received 0.125 mg, 0.250 mg of VLNTX or placebo daily for 10 days, together with the routine clonidine-based protocol. Self-reported and observer ratings of withdrawal severity and adverse events were measured on the 1st, 4th and 10th day of treatment. Runny eyes (p = 0.006), anxiety (p = 0.031) and dehydration (p = 0.014) were reduced during the whole 10 days in the 0.125 mg VLNTX-treated group compared to placebo. Only drowsiness (p = 0.043) and dysphoric mood (p < 0.001) were reduced in the 0.250 mg VLNTX-treated group. Results of 1st, 4th, and 10th-day assessment showed that most symptoms reductions were for the 0.125 mg VLNTX and the placebo group in the 1st and 4th days, respectively. On the 10th day, there was not any significant difference between 0.250 mg VLNTX-treated group and placebo group. No adverse effect was observed. In the starting days of detoxification, VLNTX can reduce the withdrawal symptoms, but the efficacy declined by passing time. Further studies are needed to test the utility of this new therapeutic approach.

Keywords

Naltrexone Opioid Metabolic detoxification Substance withdrawal syndrome 

Notes

Acknowledgements

We should appreciate the kind support of Deputy of Research at Mashhad University of Medical Sciences. This project is performed as the MD thesis of the first author (88725). The help of Dr. Malihe Dadgarmoghadam in English editing of the primary version of this manuscript is also appreciated.

Compliance with ethical standards

Conflict of interest

Authors have no conflict of interest to declare.

Supplementary material

43188_2019_8_MOESM1_ESM.docx (34 kb)
Supplementary material 1 (DOCX 34 kb)

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Copyright information

© Korean Society of Toxicology 2019

Authors and Affiliations

  • Reza Afshari
    • 1
    • 2
  • Majid Khadem-Rezaiyan
    • 3
    Email author
  • Hoda Khatibi Moghadam
    • 4
  • Mahdi Talebi
    • 5
  1. 1.Addiction Research Centre, Imam Reza (p) HospitalMashhad University of Medical SciencesMashhadIran
  2. 2.BC Centre for Disease ControlVancouverCanada
  3. 3.Clinical Research Development Unit, Faculty of MedicineMashhad University of Medical SciencesMashhadIran
  4. 4.Department of Psychiatry, School of MedicineMashhad University of Medical SciencesMashhadIran
  5. 5.Department of Family MedicineMashhad University of Medical SciencesMashhadIran

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