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

Toxicological Research 2020년 36권 1호 p.21 ~ 27
 ( Afshari Reza ) - Mashhad University of Medical Sciences Imam Reza (p) Hospital Addiction Research Centre

 ( Khadem-Rezaiyan Majid ) - Mashhad University of Medical Sciences Faculty of Medicine Clinical Research Development Unit
 ( Moghadam Hoda Khatibi ) - Mashhad University of Medical Sciences School of Medicine Department of Psychiatry
 ( Talebi Mahdi ) - Mashhad University of Medical Sciences Department of Family Medicine

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?

키워드

Naltrexone; Opioid; Metabolic detoxification; Substance withdrawal syndrome
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