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Evaluation of the effect of oral administration of Naloxone on bowel habit in patients on methadone maintenance therapy

Protocol summary

Study aim
Evaluation of the effect of oral administration of Naloxone on bowel habit in patients on methadone maintenance therapy
Design
A randomized, double blind placebo control,Superiority, parallel groups, clinical trail on 80 precipitants.The blinded therapists of Harm Reduction Centers delivers 15 capsules to every patient and assesses the current situations and their outcomes.
Settings and conduct
the study will conduct in 4 Harm Reduction Centers of Mashhad . The blinded therapists of HRCs delivers 15 capsules to every patient and assesses the current situations and their outcomes
Participants/Inclusion and exclusion criteria
Participant in the MMT( <75 mg /day) program for at least three months. they will exclude if they have : Past history of GI surgery (Except Appendectomy), Thyroid disease, diabetes mellitus. Hypercalcemia, renal failure, using Tricyclic antidepressant, Using Calcium Chanel blockers Hypertension, cardiac disease, Multi-drugs abuser, Using anticholinergic drugs, Pregnancy, Recently weight loss More then 4, NVD or Past history of Severe labor and Parkinsonism.
Intervention groups
80 methadone maintenance treated precipitants will divide to 4 groups who receive 0,0.5,2 or 4 mg/day oral naloxane capsules. The previous laxative treatment will continue.
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: IRCT20190207042648N2
Registration date: 2020-08-01, 1399/05/11
Registration timing: registered_while_recruiting

Last update: 2020-08-01, 1399/05/11
Update count: 0
Registration date
2020-08-01, 1399/05/11
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
2020-07-22, 1399/05/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral administration of Naloxone on bowel habit in patients on methadone maintenance therapy
Public title
The effect of oral Naloxone on Methadone induced constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participant in the MMT program for at least three months Willingness to participate in research studies Receive methadone less than 75 mg /day
Exclusion criteria:
Past history of GI surgery (Except Appendectomy) History of Thyroid disease History of diabetes mellitus. Hypercalcemia renal failure using Tricyclic antidepressant Using Calcium Chanel blockers Hypertension cardiac disease Multi-drugs abuser Using anticholinergic drugs Pregnancy Recently weight loss More then 4 NVD or Past history of Severe labor Parkinsonism
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be divided 4 groups by simple individual randomization method. When a patients referred to clinic will be divided into 4 groups by sealed envelops.
Blinding (investigator's opinion)
Double blinded
Blinding description
The precipitants will be blinded about the treatment. Researcher tells them " you will treat by a Naloxane capsule ( various doses) or Placebo". The evaluators ( Physicians of clinics) will be blinded on the groups treatment. Others (researcher, analyzer and person responsible for patient care) know the groups.
Placebo
Used
Assignment
Parallel
Other design features
In this study 3 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
2019-07-06, 1398/04/15
Ethics committee reference number
IR.MUMS.REC.1398.128

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 start, 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 start , one and two weeks later ( end of research)
Method of measurement
PAC-SYM questionnaire

Secondary outcomes

1

Description
constipation scoring
Timepoint
At start , one and two weeks later ( end of research)
Method of measurement
PAC-SYM questionnaire and Constipation Scoring System

2

Description
Opiate withdrawal scoring
Timepoint
One and two weeks later ( end of research)
Method of measurement
opiate withdrawal scale

Intervention groups

1

Description
Intervention group:they will be treated by oral naloxane capsules ( 0.5 or 2 or 4 mg/day) .Also, they will be treated by their previous laxative medication without change.
Category
Treatment - Drugs

2

Description
Control group: they will be treated by their previous laxative medication without change. They will receive placebo.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
4 hazard reduction clinics of Mashhad city /Iran
Full name of responsible person
Mohammad Moshiri
Street address
ٍEbnesina Street, Emam Reza Hospital, Clinical toxicology department.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2515
Fax
+98 51 3802 2515
Email
moshirimo@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafagodi
Street address
Central office of Mashhad University of Medical Sciences, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/index.php/component/content/article/62-vcresearch/514-tell
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
Dr Mohammad Moshiri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Department of clinical toxicology , Emam Reza hospital, Ebnesina Avenue, Mashhad Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51385430319
Fax
+98 51 3854 3031
Email
Moshirimo@gmail.com
Web page address
http://emamreza.mums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Moshiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Department of clinical toxicology , Emam Reza hospital, Ebnesina Avenue, Mashhad Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
+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
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Department of clinical toxicology , Emam Reza hospital, Ebnesina Avenue, Mashhad Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
+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
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
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