In this experimental study 60 methamphetamine-dependent patients admitted to addiction clinics or psychiatric clinics in the city was selected after completing an informed consent to participate in the study by the patient or guardian him, Randomized to two groups: standard treatment (rispredone) and intervention (methylphenidate) are divided. Inclusion criteria:Methamphetamine dependence(More than 10 times the regular use of methamphetamine or 10 days); ;Positive Methamphetamine urien test ;
Age 18-65 ; note dependency to other opioid and opium ;
Exclusion criteria: siezer;tardive dyskinesia or tic;
gravidity;past history of methyl phenidate craving;
past history of diabetes or MI;.In the first and last study complited questionnaires contained demographic information and past hisstory and phisical exam and psycological exam.this information counain petatia and sleep and daily activity and psycoic reaction and craving .The paitents deveised two groups(standard treatment and intervention). standard group give rispredone1mg during 1week,than 1mg/bid during 3 week .intervention group give methylphenidate10mg/day during 2week,than 7,5 mg/day during 1 week ,than 5 mg/day during 1week.Both groups information is coulculated than therapuotic effect comperesion is analysed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202159018N1
Registration date:2012-04-16, 1391/01/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-16, 1391/01/28
Registrant information
Name
Akram Rasti Barzoki
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3505
Email address
m_rasti@in.iut.ac.ir
Recruitment status
Recruitment complete
Funding source
Tavana clinic
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between therapeotic effects of methylphenidate with rispredone in methamphetamin dependent patients
Public title
Comparison between therapeotic effects of methylphenidate with rispredone in cristal dependent patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Methamphetamine dependence(More than 10 times the regular use of methamphetamine or 10 days); ;Positive Methamphetamine urien test ;
Age 18-65 ; note dependency to other opioid and opium ;
Exclusion : siezer;tardive dyskinesia or tic;
gravidity;past history of methyl phenidate craving;
past history of diabetes or MI;past history of allegy to rispredone;
past history of suicide;under treatment by anti psychotic drug or mood stabilizer or inhibitor CYP2D6 drugs
Age
From 18 years old to 65 years old
Gender
Both
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
medical univercity
Street address
sardasht site
City
arak
Postal code
Approval date
2012-02-06, 1390/11/17
Ethics committee reference number
901205
Health conditions studied
1
Description of health condition studied
methamphetamin dependency
ICD-10 code
T43.6
ICD-10 code description
T43.6
Primary outcomes
1
Description
craving
Timepoint
befor and during and after invetervention
Method of measurement
psycological exam
2
Description
sleep condition improve
Timepoint
befor and during and after invetervention
Method of measurement
Beck questionnaire
3
Description
psycotic reaction
Timepoint
befor and during and after invetervention
Method of measurement
Beck questionnaire and psycological exam
Secondary outcomes
empty
Intervention groups
1
Description
standard group give rispredone1mg during 1week,than 1mg/bid during 3 week
Category
Treatment - Drugs
2
Description
intervention group give methylphenidate10mg/day during 2week,than 7,5 mg/day during 1 week ,than 5 mg/day during 1 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tavana clinic
Full name of responsible person
Dr Hasan Solhi
Street address
Emam street,forward Valiasr hospital
City
Arak
2
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Akram Rasti
Street address
Valiasr
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tavana clinic
Full name of responsible person
Dr Hasan Solhi
Street address
Emam street.forward Valiasr hospital
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tavana clinic
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
arak medicin univercity
Full name of responsible person
Rasti barzoki Akram
Position
Student
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak
Postal code
Phone
+98 86 1222 0224
Fax
+98 22 48960
Email
fotroshozoor yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hasan Solhi
Position
Associate Professor, Technical Training Instructor Maintenance Treatment Clinic for treatment of dru