跳至主要内容
临床试验/NCT05569031
NCT05569031已完成4 期

A Comparative Study of the Efficacy of Venlafaxine and Naltrexone for Relapse Prevention in Patients With Opioid Use Disorder Attributed to Tramadol

Zagazig University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
52
试验地点
1
主要终点
detoxification stage

研究概览

简要总结

Tramadol abuse is a public health problem in Egypt. There are no approved medications for treatment of withdrawal symptoms or prevention of relapse in patients with tramadol abuse. The objective of this study was to compare the efficacy of venlafaxine and lofixidine in treating the withdrawal symptoms and to compare between venlafaxine and naltrexone in relapse prevention of tramadol abuse. Patients with tramadol abuse will be divided randomly to use venlafaxine or lofixidine after discontinuation of tramadol. The efficacy will be measured by the Clinical Opiate Withdrawal Scale. The medications will be used for 10 days after discontinuation of tramadol. After the detoxification stage, patients who used venlafaxine will continue to use it while patients who used lofixidine will use naltrexone during the relapse prevention phase (2 months).

详细描述

Introduction Venlafaxine is a nontricyclic antidepressant that selectively inhibits serotonin reuptake at low doses, but at higher doses, it blocks neuronal reuptake of serotonin, norepinephrine, and, to a lesser degree, dopamine (Debonnel et al., 2007).

Venlafaxine was also proved to have analgesic and antinociceptive effects through opioid mechanisms (Markowitz & Patrick, 1998; Schreiber et al., 1999; Schreiber et al., 2002).

In the study of McDowell et al. (2000), venlafaxine was successfully used to treat patients with cocaine dependence comorbid with major depression. In animal studies, venlafaxine demonstrated effectiveness to attenuate morphine withdrawal symptoms (Lu et al., 2001) and attenuate acquisition of intravenous self-administration of heroin in rats (Magalas et al., 2005). Lin et al. (2008) found that venlafaxine is effective in alleviating withdrawal symptoms of heroin with good tolerability and safety.

Lofixidine works by blocking the release of norepinephrine, a hormone similar to adrenaline that contributes to opioid withdrawal symptoms. Lofexidine is a non-opioid prescription medicine used in adults to help with the symptoms of opioid withdrawal that may happen when you stop taking an opioid suddenly.

Naltrexone, is an opioid antagonist, without abuse liability and the oral formulation was found to be a safe option for motivated individuals who prefer not to be treated with opioid agonist medication or where opioid agonist medications are not legally available (Krupitsky et al., 2010, Ling et al., 2012, Mooney, 2016). Although oral naltrexone had a limited side effect profile, the clinical evidence demonstrating its efficacy for the treatment of opioid use disorder has revealed limitations in its use, particularly as it requires detoxification and a several days period of opioid abstinence prior to initiation (Ling et al., 2012, Nunes et al., 2015, Mooney, 2016).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria:
  • All patients should meet DSM-IV criteria for opioid use disorder.
  • Both genders will be included.
  • Age will be above 18 years.
  • All socioeconomic classes and educational levels will be included.
  • Exclusion criteria:
  • Age: 18 years or below.
  • Presence of mental retardation, dementia or delirium. .
  • Pregnancy or lactation.
  • Known history of allergy, adverse effects or sensitivity to the study medication.
  • Unstable psychiatric or medical condition.
  • Immediate suicide risk.
  • Regular use of psychoactive drugs or dependence on substances other than opioids, nicotine, or caffeine.

排除标准

  • 未提供

研究组 & 干预措施

venlafaxidine

Active Comparator

venlafaxine 75-225 mg per day.

干预措施: Venlafaxine (Drug)

Lofixidine

Active Comparator

Lofixidine 1.6 to 2.4 per day.

干预措施: Lofexidine (Drug)

结局指标

主要结局

detoxification stage

时间窗: 10 days

the efficacy was measured by decrease in the score of the "Clinical Opiate Withdrawal Scale (COWS). Increase in the score means worsening and score decrease means improvement. We compared the mean + SD for all groups. COWS Score: 5- 12 = mild; 1 3-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

次要结局

  • Relapse prevention(2 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Medhat Bassiony

Professor

Zagazig University

研究点 (1)

Loading locations...

相似试验