In this randomized double-blind randomized controlled clinical trial, opioid-dependent patients seeking maintenance treatment will be screened. Our aim is to compare the efficacy and safety of opium tincture (OT) with methadone syrup for maintenance treatment.
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
Hypersensitivity to methadone syrup or other ingredients in the formulation
Pregnancy
Severe chronic respiratory disease
Head injury and raised intracranial pressure
Biliary tract disease
Monoamine oxidase inhibitors use within 14 days of the study
Then, 240 eligible participants will be randomly allocated to either opium (intervention) or methadone (active comparator) group. Both groups will be followed for 12 weeks and will receive routine psychosocial interventions. Each participant will attend a total of 31 visits and the primary outcome will be retention in treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506261556N78
Registration date:2015-07-26, 1394/05/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-26, 1394/05/04
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Number 206, 1st floor, Administrative Bldg.,Tehran University of Medical Sciences, Keshavarz Boulvard, Tehran, Iran
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2017-09-01, 1396/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Opium Tincture (OT) and Methadone for Maintenance Treatment of Opioid Dependence: A Randomized Double-blind Controlled Clinical Trial
Public title
Opium trial
Purpose
Treatment
Inclusion/Exclusion 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 pre-existing 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.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Clinical Research Ethics Board (CREB) of University of British Columbia (UBC)
Street address
Room 210, 828 West, 10th Avenue
City
Vancouver
Postal code
V5Z 1L8
Approval date
2015-05-11, 1394/02/21
Ethics committee reference number
H15-00220
Health conditions studied
1
Description of health condition studied
opioid dependence
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
retention in treatment
Timepoint
3 months
Method of measurement
number (percentage of patients in the treatment)
Secondary outcomes
1
Description
Craving
Timepoint
Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly
Method of measurement
VAS
2
Description
Withdrawal symptoms
Timepoint
Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly
Method of measurement
subjective opiate withdrawal scale (SOWS)
3
Description
physical health
Timepoint
Baseline, month 1, 2 and 3
Method of measurement
Opiate treatment index (OTI)-health section
4
Description
mental health
Timepoint
Baseline, month 1, 2 and 3
Method of measurement
Symptom Checklist 90 (SCL-90)
5
Description
severity of substance use problem
Timepoint
Baseline, month 1, 2 and 3
Method of measurement
Addiction Severity Index
6
Description
cognitive function
Timepoint
Baseline, month 1, 2 and 3
Method of measurement
Montreal Cognitive Assessment (MOCA)
7
Description
quality of life
Timepoint
Baseline, month 1, 2 and 3
Method of measurement
WHOQOL–BREF
8
Description
Client Satisfaction
Timepoint
month 3
Method of measurement
Treatment Perceptions Questionnaire (TPQ)
9
Description
Abstinence
Timepoint
Baseline, month 1, 2 and 3
Method of measurement
self-report & urine toxicology
10
Description
safety
Timepoint
Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly
Method of measurement
Adverse Events Report Form
11
Description
Cost- effectiveness
Timepoint
month 3
Method of measurement
QALY
Intervention groups
1
Description
Intervention group: Opium with patient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population
Category
Treatment - Drugs
2
Description
Active comparator: Methadone with patient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh substance use treatment clinic
Full name of responsible person
Afshar Amiri
Street address
Unit 3, 3rd floor, number 386, Dr. Gharib St., Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Tehran University of Medical Sciences
Street address
room 206, 1st floor, faculty of medicine, Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of British Columbia
Full name of responsible person
Michael Krausz
Position
MD, PhD, FRCPC
Other areas of specialty/work
Street address
number 430-5950, David Strangway Bldg, University Blvd
City
Vancouver
Province
BC
Postal code
V6T 1Z3
Phone
0016048273975
Fax
Email
michael.krausz@ubc.ca
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Full professor
Other areas of specialty/work
Street address
Number 101, education bldg., Roozbeh Psychiatry Hospital, south Kargar street
City
Tehran
Postal code
Phone
+98 215412222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sanam Javid
Position
MD
Other areas of specialty/work
Street address
Number 101, Education Bldg., Roozbeh Psychiatry Hospital, south Kargar street
City
Tehran
Postal code
Phone
+98 215412222
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)