CLINICAL STUDY: Very low dose naltrexone addition in opioid detoxification: a randomized, controlled trial

Abstract

Although current treatments for opioid detoxification are not always effective, medical detoxification remains a required step before long-term interventions. The use of opioid antagonist medications to improve detoxification has produced inconsistent results. Very low dose naltrexone (VLNTX) was recently found to reduce opioid tolerance and dependence in animal and clinical studies. We decided to evaluate safety and efficacy of VLNTX adjunct to methadone in reducing withdrawal during detoxification. In a multi-center, double-blind, randomized study at community treatment programs, where most detoxifications are performed, 174 opioid-dependent subjects received NTX 0.125 mg, 0.250 mg or placebo daily for 6 days, together with methadone in tapering doses. VLNTX-treated individuals reported attenuated withdrawal symptoms [F = 7.24 (2,170); P = 0.001] and reduced craving [F = 3.73 (2,107); P = 0.03]. Treatment effects were more pronounced at discharge and were not accompanied by a significantly higher retention rate. There were no group differences in use of adjuvant medications and no treatment-related adverse events. Further studies should explore the use of VLNTX, combined with full and partial opioid agonist medications, in detoxification and longterm treatment of opioid dependence.

Antagonists in the medical management of opioid use disorders: Historical and existing treatment strategies

“…Adjuvant medications were also used and the procedure was accomplished within 6 days 46, 47, 48. However, while very‐low‐dose naltrexone reduced withdrawal and craving, treatment retention or success was not improved 49, 50…”

Smoking and Opioid Detoxification: Behavioral Changes and Response to Treatment

“…This was a 6-day, double-blind, randomized trial evaluating the safety and efficacy of two different oral naltrexone regimens (0.125 and 0.25 mg/day) for the treatment of withdrawal in 174 OA subjects during inpatient methadone-based detoxification at two community treatment programs (Mannelli et al, 2009). Smoking cessation was not offered as part of the treatment, though access to smoking was permitted at one study site.…”

“…Patients were asked to participate in a 1-week evaluation following discharge. The screening process, treatment, and evaluation procedures are described in detail elsewhere (Mannelli et al, 2009).…”

“…Ancillary medications were available as needed. Need for, and use of ancillary medications was determined in routine clinical fashion by the nursing and medical staff (Mannelli et al, 2009).…”

“…The observed attenuation of opioid withdrawal and craving intensity using VLNTX for the duration of detoxification was explained with its ability to reduce mu-opioid receptor activity and dependence levels during opioid agonist treatment (Mannelli, Gottheil, Peoples, Oropeza, & Van Bockstaele, 2004;Mannelli et al, 2009). In this study, intreatment smokers were compared with nonsmokers, and with smokers who were not allowed to smoke.…”