The purpose of this study is to assess the effect of modafinil in treatment of amphetamine and methamphetamine dependent patients in a double blinded clinical trial using placebo in a 12 weeks period. In this study 50 male with the diagnosis of dependency to amphetamine bye the DSMIV-TR and no contraindication for using modafilin were chosen and randomly divided into two groups. The first group underwent a treatment with modafinil (200mg daily) for 12 weeks and the second group received only placebo. The desire for consuming methamphetamine was measure by visual analogue scale and also methamphetamine urine test, weekly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090219009N1
Registration date:2015-11-01, 1394/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-01, 1394/08/10
Registrant information
Name
Maryam Lashkaripour
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3342 6572
Email address
lashkaripour@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Zahedan University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2016-01-05, 1394/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on the effect of modafinil in treatment of amphetamine and methamphetamine dependent patients.
Public title
modafinil in treatment of crystal dependency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:male gender ;eighteen to sixty five years old
;Methamphetamine dependency approved by DMSIV-TR criteria
; Positive urine test for amphetamine and methamphetamine
; Having no contraindication for the use of modafinil
Exclusion criteria:
consuming different kind of drugs except for nicotine and methadone
; No history of psychiatric disorders
; Having medical conditions that may interfere with using modafinil
; Having suicidal thoughts and aggression
;. Participating in another study simultaneously
; Quitting the current study
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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients based on randomized method and algorithmic blocks divided into two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences.
Street address
University of Medical Sciences, Persian Gulf Blvd., Zahedan, Sistan and Baluchistan, Islamic Republic Of Iran.
City
Zahedan
Postal code
9816743463
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
6755
Health conditions studied
1
Description of health condition studied
Amphetamine-Methamphetamine Dependency
ICD-10 code
F11.6
ICD-10 code description
Mental and behavioral disorders due to use of other stimulants, dependence syndrome
Primary outcomes
1
Description
measure of craving
Timepoint
At the onset of the study and then weekly
Method of measurement
visual analogue of craving score
2
Description
Measuring the severity of dependency
Timepoint
At the onset of the study and then weeks 6th and 12th
Method of measurement
Dependency severity index
3
Description
Measuring the severity of depression
Timepoint
At the onset of the study and then weeks 6th and 12th
Method of measurement
Beck’s Depression Inventory
4
Description
Measuring the aggression severity
Timepoint
At the onset of the study and then weeks 6th and 12th
Placebo made in the Pharmacology college of Zabol medical university of medical sciences taking orally per day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharan’s Psychiatry and Mental Health Hospital
Full name of responsible person
Amir Adibi
Street address
Baharan’s Psychiatry and Mental health Hospital, Imam Khomeini Ave., Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University Of Medical Sciences
Full name of responsible person
Hooshang Rafighdoost
Street address
Research center of Zahedan University of Medical Sciences, University of Medical Sciences, Persian Gulf Blvd., Zahedan, Sistan and Baluchistan, Islamic Republic Of Iran
City
Zahedan
Grant name
125401
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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 College
Full name of responsible person
Amir Adibi
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Baharan’s Psychiatry and Mental health Hospital, Imam Khomeini Ave., Zahedan
City
Zahedan
Postal code
9819713977
Phone
+98 54 3351 3777
Fax
Email
amir771155@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University Of Medical Sciences
Full name of responsible person
Maryam Lashkaripour
Position
Associated Professor in Psychiatry
Other areas of specialty/work
Street address
Baharan’s Psychiatry and Mental health Hospital, Imam Khomeini Ave., Zahedan
City
Zahedan
Postal code
9819713977
Phone
+98 54 3352 2636
Fax
Email
dr_lashkaripour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Lashkaripour
Position
Faculty of Medical College/Associated Professor of Psychiatry
Other areas of specialty/work
Street address
Baharan’s Psychiatry and Mental health Hospital, Imam Khomeini Ave., Zahedan
City
Zahedan
Postal code
9817669749
Phone
+98 54 3342 5672
Fax
Email
dr_lashkaripour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)