Evaluation of the effect of oral administration of Naloxone on opium induced constipation of patients treated by opium tincture maintenance therapy
Design
A double-blind clinical trial study with placebo. The sample size is 120 people (40 people in each group). The blinded therapist delivers the capsules to each patient and assesses the current situations and their outcomes.
. Others of the research team (researcher, analyzer and person responsible for patient care) know which patients receive which treatment.
Settings and conduct
The study will conduct in 2 Harm Reduction Centers of Mashhad . The blinded therapists of HRCs delivers 7 coded capsules after initial evaluation ( for seven days ). The researcher will call to the participants next day to evaluate intolerable opiate withdrawal syndrome. If it is happen, the patient will be excluded. Others will be evaluated at the end of the first week and re-treated for one week again. They will also be evaluated at the end of research.
Participants/Inclusion and exclusion criteria
The participants that are in the opium tincture treatment ( less than 10 ml per day ) in the 5 first months and had 20 to 50 years old. They will exclude if they have any physically condition could precipitate constipation ( see exclusion criteria )
Intervention groups
One hundred twenty patients treated with opium syrup will be divided into three groups of placebo recipients and recipients of 2 and 4 mg oral naloxone doses daily for two weeks. None of the patients discontinued their previous treatments.
Main outcome variables
Constipation score, Withdrawal scoring, total amounts of laxative use in past 2 weeks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190207042648N3
Registration date:2021-02-16, 1399/11/28
Registration timing:prospective
Last update:2021-02-16, 1399/11/28
Update count:0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Mohammad Moshiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3878 2615
Email address
moshirimo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double-blind placebo-controlled randomized clinical trial on the use of oral naloxone on constipation of patients treated by opium tincture
Public title
Effect of oral naloxone on constipation of patients treated by opium tincture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants that are in the opium tincture treatment in the 5 first months.
Willingness to participate in research studies.
Receiving the average dose of the opium tincture less than 10 CC in the last month.
Age between 20 - 50 years.
Exclusion criteria:
Past history of GI surgery
History of Thyroid disease
History of Diabetes
Hypercalcemia
Renal failure
Using Tricyclic antidepressant
Using Calcium Chanel blockers
Hypertension
Cardiac disease
Multi-drugs abuser
Using anticholinergic drugs
Pregnancy
Recently sever weight loss
more than 4 NVD or past history of severe labor
Parkinsonism
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be divided3 groups by simple individual randomization method. When a patients referred to clinic will be divided into 3 groups by sealed envelops. Physician will treat precipitants according the code in envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient will be informed that he or she will be given medication or a placebo. Primary Assessors and Consequences (Clinic Physician) are unaware of which patient is receiving what treatment and will evaluate the patient regardless of treatment. Others of the research team know which patients receive which treatment . All drugs that are delivered to patients are in the form of packages with the code and the form of drugs is the same (the drug does not have a specific smell or taste).
Placebo
Used
Assignment
Parallel
Other design features
In this study 2 doses of Naloxone were compared by placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Gharashi building, Danshghah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.609
Health conditions studied
1
Description of health condition studied
Drug induced constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
constipation score
Timepoint
At the start of treatment , one and two weeks later (end of research)
Method of measurement
CONSTIPATION SCORING SYSTEM and Briston scoring
2
Description
Defecation in the three areas of abdominal, rectal and feces
Timepoint
At the start of treatment , one and two weeks later (end of research)
Method of measurement
PAC-SYM questionnaire
Secondary outcomes
1
Description
Opiate withdrawal scoring
Timepoint
24 hours after starting the treatment patients were evaluated by phone call. One and two weeks later ( end of research) were scored
Method of measurement
opiate withdrawal scale
Intervention groups
1
Description
Intervention group 1: The blinded therapists of HRCs delivers 7 coded capsules contain 2 mg Naloxan ( Sigma ) after initial evaluation ( for seven days ). The capsuled were filled by faculty of pharmacy of MUMS . The researcher will call to the participants next day to evaluate intolerable opiate withdrawal syndrome. If it is happen, the patient will be excluded. Others will be evaluated at the end of the first week and re-treated for one week again. They will also be evaluated at the end of research. The patients can use their lubricant medications if they need.
Category
Treatment - Drugs
2
Description
Intervention group2: The blinded therapists of HRCs delivers 7 coded capsules contain 4 mg Naloxan ( Sigma ) after initial evaluation ( for seven days ). The capsuled were filled by faculty of pharmacy of MUMS . The researcher will call to the participants next day to evaluate intolerable opiate withdrawal syndrome. If it is happen, the patient will be excluded. Others will be evaluated at the end of the first week and re-treated for one week again. They will also be evaluated at the end of research. The patients can use their lubricant medications if they need.
Category
Treatment - Drugs
3
Description
Control group:: The blinded therapists of HRCs delivers 7 coded capsules contain placebo after initial evaluation ( for seven days ). The capsuled were filled by faculty of pharmacy of MUMS . The researcher will call to the participants next day to evaluate intolerable opiate withdrawal syndrome. If it is happen, the patient will be excluded. Others will be evaluated at the end of the first week and re-treated for one week again. They will also be evaluated at the end of research. The patients can use their lubricant medications if they need.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
East educational research center of drug abuse and addictive behavior
Full name of responsible person
Hamid Reza Fathi
Street address
No 135, Soroosh 8 Ave, Vakil Abad Blvd, mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9188868758
Phone
+98 51 3602 6595
Email
FathiHR1@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ebn'e Sina Hospital
Full name of responsible person
Moshiri
Street address
Horr Ameli Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
Etemadl@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Research chancellery of Mashad University of Medical Science, Daneshgah Ave, Mashhad. Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Moshiri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Department of clinical toxicology, Emam Reza Hospital, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
moshirim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Moshiri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Department of clinical toxicology, Emam Reza Hospital, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Moshirimo@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Moshiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Department of clinical toxicology, Emam Reza Hospital, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Moshirimo@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available