Comparison of 0.125 and 0.250 mg of Naltrexone with Placebo in Decreasing Withdrawal Syndrome in Patients with Opium Addiction Referring to Addiction Treatment Clinic of Imam Reza (p) Hospital: A Clinical Trial
Purpose: Evaluating the Effects of 0.125 and 0.250 mg of Naltrexone in Contrast to Placebo in Decreasing the Symptoms of Withdrawal Syndrome
Design: Double-Blind Randomized Control Trial, Single Center, Trial Phase 2-3,
Population: Opioid Dependent Subjects Referred to Addiction Treatment Clinic in Imam Reza (p) Hospital
Inclusion: 18-65 Years Old Male Patients
Exclusion: Patients with Cancer or Pain Syndrome
Sample Size: 3 Groups of 21 Subjects
Intervention: Evaluating the Effects of Adding 0.125 and 0.250 mg of Naltrexone in Reducing Symptoms of Withdrawal Syndrome
Time: 10 Days After the Beginning of Detoxification
Outcome: Reducing the Symptoms of Withdrawal Syndrome
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013081914404N1
Registration date:2013-11-04, 1392/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-04, 1392/08/13
Registrant information
Name
Majid Khadem-Rezaiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9262
Email address
khademrm831@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2013-09-16, 1392/06/25
Expected recruitment end date
2013-11-16, 1392/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of 0.125 and 0.250 mg of Naltrexone with Placebo in Decreasing Withdrawal Syndrome in Patients with Opium Addiction Referring to Addiction Treatment Clinic of Imam Reza (p) Hospital: A Clinical Trial
Public title
The Effects of Naltrexone in Opioid Detoxification
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Male patients who choose outpatient protocol for detoxification of opioids including opium, heroin, crack and tramadol ;filling the consent
Exclusion Criteria: Cancer; Known pain syndrome; Diabetes
Age
From 18 years old to 65 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Before Golestan Crossroad, Daneshgah Ave., Mashhad, Iran
City
Mashhad
Postal code
91375-345
Approval date
2010-09-25, 1389/07/03
Ethics committee reference number
88725
Health conditions studied
1
Description of health condition studied
opium addicted patients
ICD-10 code
F11
ICD-10 code description
Mental and behavioral disorders due to use of opioids
Primary outcomes
1
Description
clinical findings of withdrawal syndrome
Timepoint
1, 4 and 10 days after the beginning of study
Method of measurement
clinical examination by researcher
Secondary outcomes
empty
Intervention groups
1
Description
two Intervention groups treated with naltrexone made by researcher in very low dose of 0.125 and 0.250 mg used oral and daily for 10 days
Category
Treatment - Drugs
2
Description
Control group treated with sugar powder made by researcher used oral and daily for 10 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Addiction Treatment Clinic of Imam Reza (p) Hospital
Full name of responsible person
Dr. Reza Afshari
Street address
Addiction Treatment Clinic, Imam Reza (p) Hospital, Ibn Sina Ave., Mashhad, Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Ramezani
Street address
Ghoreishi Building, Before Golestan Crossroad, Daneshgah Ave., 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
Vice Chancellor for Research of 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
Medical Toxicology Research Center of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Reza Afshari
Position
MD, Clinical Toxicologist, Associate Professor
Other areas of specialty/work
Street address
Toxicology Ward, Imam Reza (p) Hospital, Imam Reza (p) Square, Ibn Sina Ave., Mashhad, Iran
City
Mashhad
Postal code
9137913316
Phone
+98 51 1802 2148
Fax
Email
AfshariR@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Toxicology Research Center of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Reza Afshari
Position
MD, Clinical Toxicologist, Associate Professor
Other areas of specialty/work
Street address
Toxicology Ward, Imam Reza (p) Hospital, Imam Reza (p) Square, Ibn Sina Ave., Mashhad, Iran
City
Mashhad
Postal code
9137913316
Phone
+98 51 1802 2148
Fax
Email
AfshariR@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Community Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Khadem Rezaiyan
Position
Resident of Community Medicine
Other areas of specialty/work
Street address
Department of Community Medicine, Medical Faculty, Ferdowsi Campus, Azadi Square, Mashhad, Iran
City
Mashhad
Postal code
917794-8564
Phone
+98 51 1882 8888
Fax
+98 51 1882 8560
Email
khademrm921@mums.ac.ir, majidrezaiyan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)