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The Pattern of Opioid Withdrawal Signs and Symptoms in Three Groups: 1. Patients undergoing Clonidine Abstinence Therapy, 2. Patients on starting clinical dose of Methadone Maintenance Therapy (MMT), and 3. Patients admitted for short-time detoxification with Methadone in Opioid Addict Subjects who were Referred to Imam-Reza Hospital Rehabilitation Center and Toxicology Ward – Mashhad from November 2008 to October 2009

Protocol summary

Summary
This randomized clinical trial study was designed to demonstrate the pattern of Opioid Withdrawal signs and symptoms in three groups. Each group contains 30 patients which makes a total patient of 90. The patients were selected from admitted patients in toxicology ward and referred to Rehabilitation Center of Imam-Reza Hospital. The patients will be randomly assigned to receive Clonidine Abstinence Therapy for 10 days, Methadone Maintenance Therapy (MMT) for 45 days, or short-time detoxification with Methadone for 5 days. The withdrawal signs and symptoms including Pain, nausea and vomiting, muscle twitching, rhinorrhea, yawning, diaphoresis, tremor, lacrimation, agitation, muscle aches, bone pain, arthralgia, piloerection, pupil size, abdominal pain, diarrhea, anxiety, dysphoric mood, etc. were compared between the three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138706121187N1
Registration date: 2010-01-09, 1388/10/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-01-09, 1388/10/19
Registrant information
Name
Reza Afshari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 8973
Email address
afsharir@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2008-11-21, 1387/09/01
Expected recruitment end date
2009-11-21, 1388/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Pattern of Opioid Withdrawal Signs and Symptoms in Three Groups: 1. Patients undergoing Clonidine Abstinence Therapy, 2. Patients on starting clinical dose of Methadone Maintenance Therapy (MMT), and 3. Patients admitted for short-time detoxification with Methadone in Opioid Addict Subjects who were Referred to Imam-Reza Hospital Rehabilitation Center and Toxicology Ward – Mashhad from November 2008 to October 2009
Public title
The Pattern of Opioid Withdrawal Signs and Symptoms in Three Groups
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: will to enter the study, Having no positive history of a psychological disorder, Not using any psychological either neurological drugs, Having no positive history of a cardiovascular disease, Being male, age between 18 to 60 years old Exclusion criteria: Discontinuing the treatment, Leaving the hospital sooner than the proper time
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah Street, Mashhad, IRAN
City
Mashhad
Postal code
9138913131
Approval date
2008-01-19, 1386/10/29
Ethics committee reference number
6367

Health conditions studied

1

Description of health condition studied
Opioid Addiction
ICD-10 code
F11.3
ICD-10 code description
Mental and behavioural disorders due to use of opioids,withdrawal state

Primary outcomes

1

Description
less opioid withdrawal signs and symptoms
Timepoint
Daily
Method of measurement
The Pattern of Opioid Withdrawal Signs and Symptoms using Fultz chart

Secondary outcomes

empty

Intervention groups

1

Description
In the first group, patients are given Clonidine 0.1 mg per oral q 12 hours, Benzodiazepine (Chlorodiazepoxide 10mg at 6 Am, 10 mg at 2 Pm and 20 mg at 10 Pm per oral), Indomethacin 100 mg if necessary, Omeprazole 1 mg per oral before eating breakfast, Ibuprofen 400 mg q 12 hours per oral, with Risperidone 1 mg daily, and with or without Gabapentin and if needed Serum and Vitamin C in a 10 day period of time
Category
empty

2

Description
Patients on Methadone Maintenance Therapy (MMT) for 45 days, are given Methadone 40 mg per oral in the first day and then this dose will be increased 5 mg daily for disappearing the withdrawal signs and symptoms at most until the 10th day and then this dose will gradually be reduced to zero until the end of the 45 day period, pain killer (NSAIDs (Indomethacin 100 mg if necessary) ) in the first ten days and also MOM syrup 10 cc q 8 hours per oral
Category
Treatment - Drugs

3

Description
The patients in the third group, are given Methadone 10 mg in the first day, 5 mg in the second and third day and nothing in the forth and fifth day, and also Maintenance serum of ⅓⅔ 2 Lit daily IV if necessary,Clonidine 0.1 mg per oral q 12 hours, Chlorodiazepoxide 10mg at 6 Am, 10 mg at 2 Pm and 20 mg at 10 Pm per oral, Indomethacin 100 mg if necessary, Omeprazole 1 mg per oral before eating breakfast, Ibuprofen 400 mg q 12 hours per oral, with Risperidone 1 mg daily
Category
empty

Recruitment centers

1

Recruitment center
Name of recruitment center
Toxicology ward, Medical Toxicology Research Center, Imam-Reza University Hospital
Full name of responsible person
Dr. Reza Afshari - Ali Javidi D B
Street address
Imam-Reza General Hospital - Mashhad - IRAN
City
Mashhad

2

Recruitment center
Name of recruitment center
Addiction Rehabilitation Clinic, Imam-Reza General Hospital, Mashhad
Full name of responsible person
Dr. Reza Afshari
Street address
Imam-Reza General Hospital - Mashhad - IRAN
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Jalil Tavakkol Afshari - Research Vice Chancellor of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Boo-ali research center,Boo-ali Square, Ferdowsi Square,Mashhad,IRAN
City
Mashhad
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
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Reza Afshari
Position
Assistant Professor of Toxicology in Mashhad University of Medical Sciences - MD, M.PH.,M.Sc.,Ph.D.
Other areas of specialty/work
Street address
Imam-Reza Hospital Toxicology Ward ,Medical Toxicology Research Center – Mashhad
City
Mashhad
Postal code
Phone
+98 51 1859 8973
Fax
Email
afsharir@mums.ac.ir,javidida811@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Javidi D. B.
Position
Medical student of Mashhad University of Medical Sciences
Other areas of specialty/work
Street address
Imam-Reza University Hospital Transplantation Ward – Mashhad
City
Mashhad
Postal code
Phone
+98 51 1881 2750
Fax
Email
a_javidi@hotmail.com,javidida811@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Javidi D B
Position
Medical student
Other areas of specialty/work
Street address
Imam-Reza University Hospital Transplantation Ward – Mashhad - IRAN
City
Mashhad
Postal code
Phone
+98 51 1881 2750
Fax
Email
javidida811@mums.ac.ir, a_javidi@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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