Comparing Opium Tincture (OT) With Methadone for Medication-assisted Treatment of Opioid Use Disorder
OT-RCT
1 other identifier
interventional
204
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2017
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2015
CompletedFirst Posted
Study publicly available on registry
July 20, 2015
CompletedStudy Start
First participant enrolled
June 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2018
CompletedJuly 12, 2019
July 1, 2019
9 months
July 13, 2015
July 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention in treatment
percent of participants retained in the treatment
three months
Secondary Outcomes (11)
Craving
Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly
Withdrawal symptoms
Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly
Physical health
Baseline, month 1, 2 and 3
Mental health
Baseline, month 1, 2 and 3
Cognitive function
Baseline, month 1, 2 and 3
- +6 more secondary outcomes
Study Arms (2)
Opium
EXPERIMENTALpatient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population
methadone
ACTIVE COMPARATORpatient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Tehran University of Medical Sciencescollaborator
- Iran National Science Foundationcollaborator
- AJA University of Medical Sciencescollaborator
Study Sites (4)
Dodange Substance use disorder treatment center
Moḩammadābād, Mazandaran, Iran
Kian substance use treatment center
Sari, Mazandaran, Iran
Tavalodi Digar
Isfahan, Iran
Rooz-e-No substance use treatment center
Shiraz, Iran
Related Publications (2)
Nikoo M, Kianpoor K, Nikoo N, Javidanbardan S, Kazemi A, Choi F, Vogel M, Gholami A, Tavakoli S, Wong JSH, Moazen-Zadeh E, Givaki R, Jazani M, Mohammadian F, Moghaddam NM, Schutz C, Jang K, Akhondzadeh S, Krausz M. Opium tincture versus methadone for opioid agonist treatment: a randomized controlled trial. Addiction. 2023 Feb;118(2):284-294. doi: 10.1111/add.16030. Epub 2022 Sep 7.
PMID: 35971297DERIVEDNikoo M, Moazen-Zadeh E, Nikoo N, Javidanbardan S, Kazemi A, Choi F, Vogel M, Gholami A, Tavakoli S, Givaki R, Jazani M, Mohammadian F, Markazi Moghaddam N, Goudarzi N, Schutz C, Jang K, Akhondzadeh S, Krausz M. Comparing opium tincture and methadone for medication-assisted treatment of patients with opioid use disorder: Protocol for a multicenter parallel group noninferiority double-blind randomized controlled trial. Int J Methods Psychiatr Res. 2019 Mar;28(1):e1768. doi: 10.1002/mpr.1768. Epub 2019 Feb 4.
PMID: 30714249DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R Kausz, MD, PhD
University of British Columbia
- PRINCIPAL INVESTIGATOR
Shahin Akhondzadeh, PhD
Tehran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 13, 2015
First Posted
July 20, 2015
Study Start
June 22, 2017
Primary Completion
March 8, 2018
Study Completion
March 8, 2018
Last Updated
July 12, 2019
Record last verified: 2019-07