IRCT20170702034844N6招募中3 期
Comparing Efficacy of Extended-release Injectable Naltrexone (XR-NTX) with Oral Naltrexone on Opioid Abstinence among People with Opiate Use Disorder: A Triple-blind Randomized Controlled Trial
anodaroo Pazhouhan Pardis Company0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •Diagnosis of moderate to severe opiate use disorder including only opium, Shireh (opium concentrate), heroin, and/or heroin crack based on DSM 5
- •Voluntarily seeking treatment and willingness to receive antagonist maintenance treatment
- •Successful completion of medically-assisted opioid withdrawal (including a personal report of at least 7 days of abstinence from opioids, negative urinalysis test for morphine, methadone, buprenorphine and tramadol, and negative antagonist challenge test)
- •Good physical health based on medical records, physical examination and measurement of vital signs
- •Hematology tests, liver and kidney function tests in the normal range
- •In women of childbearing age agree to receive a safe method of contraception
- •Living in Tehran
- •Having a family member or companion who can monitor regular visits and daily use of the study medication
- •No severe abnormalities in the ECG
- •Ability to understand and give written informed consent to enter the study
排除标准
- •Positive antagonist challenge test
- •Positive urinalysis test for opioids (morphine) or opioid drugs (methadone, buprenorphine, tramadol)
- •Patients undergoing maintenance treatment with opioid drugs (methadone, buprenorphine, or opium tincture)
- •Request treatment and desire to receive opioids maintenance treatments with medication like methadone and buprenorphine
- •People treated with opioid antagonists or a history of continuous naltrexone injections in the past 6 months
- •Need to receive opioid medications for medical purposes such as chronic pain disorder
- •Concurrent diagnosis of other substance use disorders such as stimulants and sedatives (except nicotine and caffeine)
- •Concurrent alcohol use disorder and people who are currently need medical management for alcohol withdrawal
- •Pregnancy, lactation or women of childbearing age who are planning to become pregnant or do not use a contraceptive method
- •Having uncontrolled, major psychiatric disorders at the time of referral (e.g. mood disorders with impaired function, schizophrenia, etc.) that can interfere with participation in the study
- •Severe and uncontrolled physical conditions based on physical examination by study's physician and laboratory evaluations (e.g. uncontrolled hypertension or diabetes mellitus)
- •Having uncontrolled medical illness that can interfere with study or significantly increase medical risk. (Such as high blood pressure and uncontrolled diabetes)
- •Severe physical illness (including acute renal failure, endocarditis and tuberculosis)
- •Liver failure, acute hepatitis or more than threefold increase in liver enzymes
- •Thrombocytopenia and a history of coagulation disorders
- •Planning for surgery during the study period
- •Inadequate physical condition for safe intramuscular injection of extended-release naltrexone, body mass index above 40 (excessive adipose tissue in the buttocks) or severe weight loss
- •The presence of AIDS-indicator disease
- •Known sensitivity to naltrexone, polylactide-co-glycolide, arboxymethylcellulose, or other components of the effective and soluble extended-release injectable naltrexone
- •Serious suicidality or a history of suicide last year
- •Last year history of drug overdose that led to hospitalization
- •Being on probation or under judicial supervision with the possibility of re-arrest and re-imprisonment
- •Inability to understand the study protocol or respond to evaluations as well as lack of proper communication with therapists
研究者
相似试验
招募中
不适用
Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteersIRCT20130603013572N4ano Daru pharmaceutical Co.48
尚未招募
Unknown
A clinical study comparing Hemolasertherapy and I-PRF for the treatment of Black triangleCTRI/2024/08/072144Deepikashree K
招募中
3 期
Comparison of the therapeutic effect of injectable pantoprazole and famotidine in patients with epigastric paiIRCT20230614058478N1Zahedan University of Medical Sciences80
尚未招募
2 期
Effect of two doses of ketorolac in the treatment of acute renal colic paiRenal Colic.Calculus of kidneyN20.0IRCT20201018049062N1Zahedan University of Medical Sciences160
尚未招募
2 期
Effect of two different dose of Fentanyl to decrease adverse effect of intubatioCTRI/2024/06/069395Goverment of Gujarat