Objectives: To assess the interaction effect of using ranitidine versus not using ranitidine on morphine dignostic test in addicts.
Design: a before after clinical trail.
Setting and conduct: The valenteer participants who will refer to Hamadan School of Pharmacy during the study period will be enrolled into the trial.
Inclusion criteria: (a) age of 18 to 40 years; (b) Not using any form of drugs during the last 72 hours.
Exclusion criteria: Conterindication of ranitidine usage.
Intervention: taking 150 mg oral ranitidine as a single dose.
Control: comparison with before intervention.
Primary outcome: diagnostic test of morphine by taking a urine sample before and 12 hours after intervention.
Secondary outcome: nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501189014N54
Registration date:2015-01-21, 1393/11/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-21, 1393/11/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2015-05-31, 1394/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Interaction effect of using ranitidine versus not using ranitidine on morphine dignostic test in addicts: a before after clinical trail
Public title
Interaction effect of using ranitidine versus not using ranitidine on morphine dignostic test in addicts
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 18 to 40 years; (b) Not using any form of drugs during the last 72 hours.
Exclusion criteria: Conterindication of ranitidine usage.
Age
From 18 years old to 40 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: this is a before after trial, thus randomization is not possible.
Blinding: this is a before after trial, thus blinding is not possible
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-06-30, 1393/04/09
Ethics committee reference number
D/P/16/35/9/4136
Health conditions studied
1
Description of health condition studied
Addict
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
diagnostic test of morphine by
Timepoint
before and 12 hours after intervention
Method of measurement
taking a urine sample
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
taking 150 mg oral ranitidine as a single dose
Category
Diagnosis
2
Description
comparison with before intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Pharmacy
Full name of responsible person
Dr Fatemeh Zeraati
Street address
School of Pharmacy, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
School of Pharmacy
Full name of responsible person
Dr Fatemeh Zeraati
Position
Pharmacologist
Other areas of specialty/work
Street address
School of Pharmacy, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
fatemez415@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy
Full name of responsible person
Dr Fatemeh Zeraati
Position
Pharmacologist
Other areas of specialty/work
Street address
School of Pharmacy, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1590
Fax
Email
fatemez415@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)