The objective of this randomized, double-blind, placebo controlled study is to evaluate the efficacy of sustained-released methylphenidate in the treatment of methamphetamine dependence. 70 individuals who meet DSM-IV-TR criteria for methamphetamine dependence participate in this 12 weeks trial. The participants randomly will be allocated to two groups. Group 1( N=35) will receive 18 mg/day sustained-released methylphenidate during the first week and 36 mg/day during the second week and then will receive 54 mg/day sustained-released methylphenidate. Group 2( N=35) will receive placebo for 12 weeks.Severity of addiction will be assessed by Addiction Severity Index(ASI) at the beginning and at the end of the study. Craving will be evaluated by a visual analogue craving scale every week . Urinary screening test for methamphetamine will be carried out each weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202281556N38
Registration date:2012-03-10, 1390/12/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-10, 1390/12/20
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Tehran University of Medical Sciences
2-Kurdistan University of Medical Sciences
Expected recruitment start date
2012-03-15, 1390/12/25
Expected recruitment end date
2014-03-16, 1392/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of slow-release Methylphenidate on methamphetamine dependence: a double blind and placebo controlled trial
Public title
Slow-release Methylphenidate in the treatment of methamphetamine dependence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:Diagnosis of Methamphetamine dependence based on DSM-IV-TR ; Positive methamphetamine urinary test at the beginning of the study; age between 18-65
Exclusion Criteria: any other mental disorder on axis I except for depression;Any serious medical or neurological problem ,2- IQ <70; abusing other substances except for nicotine and methadone; history of Attention Defecit-Hyperactivity Disorder during childhood ; pregnancy and breast feeding; development of psychotic symptoms requirind pharmacotherapy; serious suicidal ideations
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2012-02-20, 1390/12/01
Ethics committee reference number
16507
Health conditions studied
1
Description of health condition studied
methamphetamine dependence
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
craving
Timepoint
Baseline and then weekly
Method of measurement
visual analogue craving scale
2
Description
addiction severity
Timepoint
Baseline and at the end of the study
Method of measurement
by Addiction SeverityIndex
3
Description
rate of use
Timepoint
Baseline and then weekly
Method of measurement
Urinary methamphetamine test
Secondary outcomes
empty
Intervention groups
1
Description
Tablets slow-release methylphenidate 18 mg/dayfor the first week, 36 mg/day for the second week and then 54 mg/day for remaining 10 weeks
Category
Treatment - Drugs
2
Description
placebo for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods Hospital
Full name of responsible person
Dr. Farzin Rezaei
Street address
No2, Pasdaran Blvd., Qods Hospital, Sanandaj
City
Sanandaj
2
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
South Kargar Sreeet, Roozbeh Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Akbar Fotouhi
Street address
Keshvarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ataollah Heydari
Street address
No1, Pasdaran Blvd, Kurdistan university of Medical Sciences, Deputy of research, Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan University of Medical Sciences
Proportion provided by this source
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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital; South Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
1337
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital-South Karegar street
City
Tehran
Postal code
1337
Phone
+98 21 5541 2222
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)