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Comparing Opium Tincture (OT) With Methadone for Medication-assisted Treatment of Opioid Use Disorder (OT-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02502175
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Tehran University of Medical Sciences
Iran National Science Foundation
AJA University of Medical Sciences
Information provided by (Responsible Party):
Michael Krausz, University of British Columbia

Brief Summary:
Patients with opioid use disorder seeking medication-assisted treatment will be recruited. Each participant will be allocated to one of the two study groups with the equal chance of receiving either opium tincture (OT) or methadone. Participants, clinical and research staff will not be aware of the medication that each patient receives. This study aims to test whether OT is as equally effective as methadone at retaining participants with opioid use disorder in medication-assisted treatment.

Condition or disease Intervention/treatment Phase
Opioid Dependence Drug: opium Drug: methadone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Opium Tincture (OT) and Methadone for Medication-assisted Treatment of Opioid Use Disorder: A Randomized Double-blind Controlled Clinical Trial
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : March 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Opium
patient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population
Drug: opium
Opium tincture (10mg/ml), manufactured by Daroupakhsh.co, Tehran, Iran.
Other Names:
  • tincture of opium
  • laudanum
  • Opium tincture

Active Comparator: methadone
patient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population
Drug: methadone
Methadone (5mg/ml), manufactured by Daroupakhsh.co, Tehran, Iran.




Primary Outcome Measures :
  1. Retention in treatment [ Time Frame: three months ]
    percent of participants retained in the treatment


Secondary Outcome Measures :
  1. Craving [ Time Frame: Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly ]
    Visual analogue scale (0-10 scale)

  2. Withdrawal symptoms [ Time Frame: Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly ]
    Subjective Opioid Withdrawal Scale (SOWS) Questionnaire

  3. Physical health [ Time Frame: Baseline, month 1, 2 and 3 ]
    Opiate Treatment Index (OTI)-Health section Questionnaire

  4. Mental health [ Time Frame: Baseline, month 1, 2 and 3 ]
    Symptom Checklist-90-Revised (SCL90-R) Questionnaire

  5. Cognitive function [ Time Frame: Baseline, month 1, 2 and 3 ]
    Montreal Cognitive Assessment (MOCA) Questionnaire

  6. Severity of substance use problem [ Time Frame: Baseline, month 1, 2 and 3 ]
    Addiction Severity Index-5th (ASI-5th) Questionnaire

  7. Quality of life score from World Health Organization Quality of Life-BREF Questionnaire [ Time Frame: Baseline, month 1, 2 and 3 ]
    World Health Organization Quality of Life-BREF (WHOQoL-BREF) Questionnaire

  8. Client Satisfaction [ Time Frame: month 3 ]
    Treatment Perception Questionnaire (TPQ)

  9. Abstinence [ Time Frame: Baseline, month 1, 2 and 3 ]
    Use of illicit opioids: Self-report / Use of amphetamines, methamphetamines, benzodiazepines: Self-report AND urine toxicology

  10. Adverse events [ Time Frame: Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly ]
    Spontaneous reports AND checklist included in the Case Report Form (CRF), physical examination and lab data

  11. Cost-effectiveness [ Time Frame: three months ]
    Cost per Quality-adjusted life-month (QALM) and Quality-adjusted life-year (QALY) is calculated using Substance Abuse Services Cost Analysis Program (SASCAP).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Opioid dependence as confirmed by DSM V diagnostic criteria
  • Willingness and ability to adhere to study protocol and follow-up schedule as determined through the pre-randomization period
  • Provide written informed consent.
  • Females of childbearing capacity must agree to use an acceptable method of birth control approved by the study investigator throughout the study.

Exclusion Criteria:

  • Active participant in another treatment program for opioid dependence within 14 days before inclusion in the study
  • Severe hepatic impairment (decompensated liver disease), a contraindication for methadone and its potential to precipitate hepatic encephalopathy.
  • Hypersensitivity to methadone syrup or other ingredients in the formulation
  • Pregnancy
  • Severe chronic respiratory disease
  • Head injury and raised intracranial pressure: Respiratory depressant effects (with CO2 retention and secondary elevation of CSF pressure) may be markedly exaggerated in the presence of head injury, or a preexisting increase in intracranial pressure. May produce effects that obscure the clinical course in participants with head injuries.
  • Biliary tract disease: may cause constriction of sphincter of Oddi.
  • Monoamine oxidase inhibitors use within 14 days of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502175


Locations
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Iran, Islamic Republic of
Dodange Substance use disorder treatment center
Mohammadabad, Mazandaran, Iran, Islamic Republic of
Kian substance use treatment center
Sari, Mazandaran, Iran, Islamic Republic of
Tavalodi Digar
Isfahan, Iran, Islamic Republic of
Rooz-e-No substance use treatment center
Shiraz, Iran, Islamic Republic of
Sponsors and Collaborators
University of British Columbia
Tehran University of Medical Sciences
Iran National Science Foundation
AJA University of Medical Sciences
Investigators
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Principal Investigator: Michael R Kausz, MD, PhD University of British Columbia
Principal Investigator: Shahin Akhondzadeh, PhD Tehran University of Medical Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Krausz, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02502175    
Other Study ID Numbers: H15-00220
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Krausz, University of British Columbia:
Opium tincture
opium
methadone
opioid dependence
opiate dependence
clinical trial
Iran
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Opium
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Antidiarrheals
Gastrointestinal Agents