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IRCT20170702034844N6 IRCT 2020-07-31 Nanodaroo Pazhouhan Pardis Company Comparing Efficacy of Extended-release Injectable Naltrexone (XR-NTX) with Oral Naltrexone 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 2020-07-22 anticipated 150 Complete https://irct.ir/trial/45796 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random codes are created by the person responsible for data randomization using the website www.sealedenvelope.com. Patients are randomly allocated to one of three study arms including injectable naltrexone + oral placebo, injectable placebo + oranl naltrexone and injectable placebo + oral placebo based on random sequence blocks with block size of 6. The codes created by the person responsible for the randomization, are attached to the medications of all three study groups, and each patient's code is given to the treatment provider in a sealed envelope, consecutively, Blinding description: Patients in all three groups receive either oral naltrexone or oral placebo as same size, color and shape gel capsules. Patients in all three groups also receive either injectable naltrexone or injectable placebo. The injectable medications are prepared by a nurse and covered with an opaque tape, in order to make injectable naltrexone and injectable placebo indistinguishable. 3 Moderate and severe opiates use disorder. Intervention 1: Intervention group: Injectable naltrexone + oral placebo: Participants in this group receive extended release naltrexone (Exopio, Nano daroo pazhouhan, 380 mg, IM) every 4 weeks and oral placebo. After preparation, extended-release naltrexone is covered by an opaque tape and is given to physician or another nurse within study site. Patients in this group is received daily placebo capsule. Intervention 2: Intervention group: Injectable placebo + oral naltrexone: Participants in this group receive injectable placebo (vial 2 of Exopio medication package) covered by an opaque tape every 4 weeks and oral naltresone capsule 50 mg per day. Intervention 3: Control group: Injectable placebo + oral placebo: Participants receive injectable placebo (vial 2 of Exopio package) covered with opaque tape every 4 weeks and oral placebo capsule daily. Yes - There is a plan to make this available What will be shared: It is planned to share IPD, study protocol and report of the clinical study. When: IPD will be shared after completion of the data gathering phase. Study protocol will be available within 3 months after successful registration of the trial. Report of the clinical study will be finalized at the end of study . To whom: Clinical researchers Conditions: IPD will be available for researchers who are conducting review studies. Study protocol and report will be published as English articles. Where to obtain: Email to the individual who is responsible for scientific inquiries of this project How to obtain: It will be responded after processing within the project team. Comments:
public Alireza Noroozi
Kargar St
Tehran Iran (Islamic Republic of) 1336616357 +98 21 5542 1144 noroozi_a@razi.tums.ac.ir Iranian National Center for Addiction Studies scientific Alireza Noroozi
Kargar St
Tehran Iran (Islamic Republic of) 1336616357 +98 21 5542 1144 noroozi_a@razi.tums.ac.ir Iranian National Center for Addiction Studies Iran (Islamic Republic of) 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 18 years 65 years Both 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 F11.2 Opioid dependence Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Injectable naltrexone + oral placebo: Participants in this group receive extended release naltrexone (Exopio, Nano daroo pazhouhan, 380 mg, IM) every 4 weeks and oral placebo. After preparation, extended-release naltrexone is covered by an opaque tape and is given to physician or another nurse within study site. Patients in this group is received daily placebo capsule. Intervention group: Injectable placebo + oral naltrexone: Participants in this group receive injectable placebo (vial 2 of Exopio medication package) covered by an opaque tape every 4 weeks and oral naltresone capsule 50 mg per day Control group: Injectable placebo + oral placebo: Participants receive injectable placebo (vial 2 of Exopio package) covered with opaque tape every 4 weeks and oral placebo capsule daily. Proportion of weeks of opioids use abstinence measured by self-report and negative urine test for morphine. Timepoint: Weekly till 24 weeks. Method of measurement: Self report and morphine urine test. Treatment completion. Timepoint: Termination of the study. Method of measurement: Checklist for weekly visits. Retention in treatment. Timepoint: Weekly till week 24. Method of measurement: Weekly visits check list. Craving (severity). Timepoint: Weekly till 24 week. Method of measurement: Visual analogue scale (VAS). Number of days using opioids during last week. Timepoint: Weekly (week 5 to 24). Method of measurement: Clinical interview (week 5 to 24). Abstinence from opioids use measured by urine test. Timepoint: Weekly (week 5 to 24). Method of measurement: Urine tests. Adherence to treatment. Timepoint: Weekly. Method of measurement: Weekly physician's visit and patient's self-report on medication use adherence. Time to dropping out of study due to positive naltrexone challenge test. Timepoint: Weekly till week 24. Method of measurement: Physician's visit. Time to dropping out of study for any reason. Timepoint: Weekly till week 24. Method of measurement: Physician's visit. Tehran University of Medical Sciences Nanodaroo Pazhouhan Pardis Company Tehran University of Medical Sciences Approved 2020-05-05 Vice- chancellor in research affairs, Tehran University of Medical Sciences Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)