In this double blind study, hospitalized patients with symptoms of methamphetamine withdrawal are selected randomly (odd and even numbers) and allocated in two groups. Each group includes 30 patients. One group will receive methylphenidate and the other group will receive modafinil for two weeks and clinical response will be evaluated every day by interview and questionnaire.
The main goal of our study will be comparing the effect of these two drugs on reduction of methamphetamine craving and withdrawal symptoms in order to find the best therapeutic choice.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022025160N2
Registration date:2016-05-05, 1395/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Jamshid Ahmadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 3070
Email address
ahmadij@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of methylphenidate and modafinil in the reduction of methamphetamine withdrawal symptoms and craving
Public title
Comparing the effect of methylphenidate and modafinil in the reduction of crystal withdrawal symptoms and craving
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients' age should be between 18 to 50 years; Patients should fill the informed consent form; Methamphetamine is the main substance of abuse.
Exclusion criteria:
Patients unwilling to participate at beginning or during the study; Methamphetamine is not the main substance of abuse.
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Science, Zand Blvd
City
Shiraz
Postal code
7194634786
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.SUMS.REC.1394.184
Health conditions studied
1
Description of health condition studied
Methamphetamine Dependency
ICD-10 code
ّF15
ICD-10 code description
Mental and behavioural disorders due to use of other stimulants, including caffeine
Primary outcomes
1
Description
craving
Timepoint
daily for 2 weeks
Method of measurement
questionnaire and interview
Secondary outcomes
empty
Intervention groups
1
Description
One group will receive methylphenidate for two weeks
Category
Treatment - Drugs
2
Description
The other group will receive modafinil for two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne Sina Hospital
Full name of responsible person
Jamshid Ahmadi M.D.
Street address
Ebne Sina Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice Chancellery for Research Affairs, Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Ahmadi M.D.
Position
Professor of Psychiatry, Director of Substance Abuse and Mental Health Research Center
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Square
City
Shiraz
Postal code
7194654743
Phone
+98 71 3646 1511
Fax
Email
jamshid_ahmadi@yahoo.comajmadij@sums.ac.ir
Web page address
sarc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Ahmadi M.D.
Position
Subspecialist in Substance Abuse
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Square
City
Shiraz
Postal code
7194654743
Phone
+98 71 3646 1511
Fax
Email
jamshid_ahmadi@yahoo.comahmadij@sums.ac.ir
Web page address
sarc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Ahmadi M.D.
Position
Professor of Psychiatry, Director of Substance Abuse and Mental Health Research Center
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Square
City
Shiraz
Postal code
7194654743
Phone
+98 71 3646 1511
Fax
+98 36273070
Email
jamshid_ahmadi@yahoo.comahmadij@sums.ac.ir
Web page address
sarc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)