To compare methadone and fentanyl in treatment of opioid withdrawal syndrome in addicted patients admitted to toxicology ICU
Design
Prospective, single-blinded, controlled pilot
Settings and conduct
In a prospective, single-blinded, controlled pilot, opioid-dependent intubated patients admitted to toxicology ICU of Loghman Hakim Hospital will alternately be assigned into either fentanyl or methadone groups. In the methadone group, they will be put on subcutaneous methadone with the initial dose of 10 mg every 12 hours (20 mg/day) as the initiation dose. The dose was subsequently adjusted based on the patients’ signs and symptoms. In the fentanyl group, the patients will be put on intravenous administration of fentanyl with the initial dose of 50-100 μg/hour and adjusted subsequently based on the patients’ response. the two groups will then be compared regarding response to treatment (COWS Scale) and time needed to respond to therapy and obviation of the withdrawal syndrome.
Participants/Inclusion and exclusion criteria
Addicted patients who are intubated and admitted to toxicology ICU are those with potential inclusion criteria. If their signs and symptoms of withdrawal initiate during ICU stay (with any severity of withdrawal) they will be included. Addiction will be confirmed by the history taken from the patients’ next of kin, positive urine tests, and initiation of clinical opiate withdrawal syndrome determined by clinical opiate withdrawal scale (COWS)
Patients with any other dependencies (such as dependency to benzodiazepines, SSRIs, etc) will be excluded
Patients who receive any medication for control of the addiction before initiation of the withdrawal signs and symptoms, will also be excluded.
Intervention groups
Group 1: Patients receiving Fentanyl
Group 2: Patients receiving Methadone
Main outcome variables
esponse to treatment and time needed to respond to therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150110020624N2
Registration date:2021-09-11, 1400/06/20
Registration timing:retrospective
Last update:2021-09-11, 1400/06/20
Update count:0
Registration date
2021-09-11, 1400/06/20
Registrant information
Name
Nasim Zamani
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4041
Email address
nasim.zamani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-20, 1399/08/30
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
2020-08-21, 1399/05/31
Actual recruitment end date
2021-05-21, 1400/02/31
Trial completion date
2021-08-10, 1400/05/19
Scientific title
Fentanyl versus Methadone in the Treatment of Withdrawal Syndrome of Addicted Patients Admitted to Toxicology ICU
Public title
Fentanyl versus Methadone and treatment of Withdrawal Syndrome In addicted patients admitted to toxicology ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Addicted patients who are intubated and admitted to toxicology ICU are those with potential inclusion criteria. If their signs and symptoms of withdrawal initiate during ICU stay (with any severity of withdrawal) they will be included. Addiction will be confirmed by the history taken from the patients’ next of kin, positive urine tests, and initiation of clinical opiate withdrawal syndrome determined by clinical opiate withdrawal scale (COWS).
Exclusion criteria:
Patients with any other dependencies (such as dependency to benzodiazepines, SSRIs, etc) will be excluded.
Patients who receive any medication for control of the addiction before initiation of the withdrawal signs and symptoms, will also be excluded.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the patients will be blinded to the type of treatment they are being given as they are unconscious and intubated.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Yaman Street- Velenjak
City
Tehran
Province
Tehran
Postal code
1971653313
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.457
Health conditions studied
1
Description of health condition studied
Withdrawal syndrome
ICD-10 code
F11.23
ICD-10 code description
ICD-10 F11.23 is a billable code used to specify a medical diagnosis of opioid dependence with withdrawal.
Primary outcomes
1
Description
Time to alleviation of withdrawal syndrome and the potency of treatment performed based on COWS scale
Timepoint
0.5 and 2 hours post administration
Method of measurement
COWS Scale (Clinical Opiate Withdrawal Scale)
Secondary outcomes
1
Description
Time to extubation- Development of complications
Timepoint
1 and 2 weeks after ICU admission
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: The patients are put on fentanyl with the initial dose of 50-100 microg/h. This dose will eventually be adjusted based on the patient response and alleviation of the signs and symptoms of withdrawal.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Toxicology ICU
Full name of responsible person
NASIM ZAMANI
Street address
Makhsus- South Karegar Street
City
Tehran
Province
Tehran
Postal code
13334311510
Phone
+98 21 5540 9534
Email
nasim.zamani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Zamani
Street address
Makhsus South Karegar Street
City
Tehran
Province
Tehran
Postal code
13334311510
Phone
+98 21 5540 9534
Email
nasim.zamani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Zamani
Position
Attending Physician
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
27 Arbor Walk Lane
City
Rancho Santa Margarita
Province
California
Postal code
92688
Phone
+1 949-320-3264
Email
nasim.zamani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Zamani
Position
Attending Physician
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
27 Arbor Walk Lane
City
Rancho Santa Margarita
Province
California
Postal code
92688
Phone
+1 494 320 3264
Email
nasim.zamani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Zamani
Position
Attending Physician
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
27 Arbor Walk Lane
City
Rancho Santa Margarita
Province
California
Postal code
92688
Phone
+1 949-320-3264
Email
nasim.zamani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The patients' data and analysis data are available and can be used after anonymization of them.
When the data will become available and for how long
After publication of the data
To whom data/document is available
Anyone needing the data for scientific and academic purposes
Under which criteria data/document could be used
The data can be used for any scientific purpose with mentioning the source of the data
From where data/document is obtainable
Nasim Zamani
What processes are involved for a request to access data/document