TY - JOUR ID - 91658 TI - Effectiveness and Safety of Haloperidol Add-on Methadone in Acute Opium Withdrawal Symptoms of Opioid-dependent Patients: A Double-blind Randomized Placebo-controlled Clinical Trial JO - Addiction and Health JA - AHJ LA - en SN - 2008-4633 AU - Ghaderi-Bafti, Fattaneh AU - Zarghami, Mehran AU - Ahmadi, Abdolkarim AU - Moosazadeh, Mahmood AU - Hadinezhad, Pezhman AU - Hendouei, Narjes AD - Department of Psychiatry, School of Medicine, Shahroud University of Medical Sciences, Shahroud AND Student Research Committee, Department of Psychiatry, School of Medicine AND Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran AD - Student Research Committee, Department of Psychiatry, School of Medicine AND Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran AD - Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran AD - Gastrointestinal Cancer Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran AD - Department of Clinical Pharmacy, School of Pharmacy AND Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran Y1 - 2021 PY - 2021 VL - 13 IS - 2 SP - 85 EP - 94 KW - Opium KW - Substance withdrawal syndrome KW - Methadone KW - Haloperidol DO - 10.22122/ahj.v13i2.287 N2 - Background: The aim of this double-blind clinical trial was to evaluate the efficacy and safety of haloperidol on acute opioid withdrawal symptoms. Methods: In this randomized double-blind clinical trial, fifty-two eligible patients were assigned to two groups according to previous opioid consumption, low dose (LD) and high dose (HD). Then, patients in each group were randomly assigned to one of the two subgroups of haloperidol or placebo. Patients in the haloperidol subgroup in LD group received 2.5 mg and in HD group received 5 mg/day haloperidol with methadone. Methadone was discontinued ten days after the beginning of the study and haloperidol or placebo continued for up to two weeks after methadone discontinuation. The severity of opioid withdrawal symptoms was assessed with the Objective Opioid Withdrawal Scale (OOWS) every other day. Findings: Although both treatment protocols either in LD or HD opioid consumption groups significantly increased the score of the OOWS over the trial period (all subgroups, P < 0.001), the combination of 2.5 mg/day of haloperidol and methadone in LD opioid consumption group showed a significant superiority over methadone alone in decreasing opium withdrawal symptoms during the study (P = 0.001). The frequency of adverse effects was comparable between two treatment protocols in both groups (P > 0.05). Conclusion: The results of this study suggest that 2.5 mg/day of haloperidol may be an effective adjuvant agent in the management of opium withdrawal symptoms in patients with LD opioid consumption. Nevertheless, results of larger controlled trials are needed before recommendation for a broad clinical application can be made UR - https://ahj.kmu.ac.ir/article_91658.html L1 - https://ahj.kmu.ac.ir/article_91658_2eb51d703435b3c8c20a06705a9c088b.pdf ER -