Comparison of the effect of two therapies methylphenidate and matrix-methylphenidate on the severity of addiction, craving and treatment abstinence in methamphetamine abusers
The aim of this study is comparison of the effect of two therapies methylphenidate and matrix-methylphenidate on the severity of addiction, craving, recurrence and treatment abstinence in methamphetamine abusers.
Design
In this research, 100 eligible patients with methamphetamine dependency diagnosis according to DSM-IV criteria are enrolled and a code was allocated to each one of them. Then, random assignment will be done by the use of computer-generated random numbers.
Settings and conduct
100 eligible patients methamphetamine abuse referred to Farabi Hospital affiliated to Kermanshah University of Medical Sciences, Kermanshah, Iran will be selected in the study. No blind design and factorial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: methamphetamine dependence diagnoses accordingly Diagnostic and Statistical Manual of Mental Disorders.
Exclusion criteria: Unwillingness to cooperate
Intervention groups
Patients will be divided into four treatment groups: matrix, methylphenidate, matrix-methylphenidate and control group. The first group (25 people) will be treated individuals, for 22 sessions of 45 minutes, twice a week for three months for matrix treatment. The second group (25 people) will receive methylphenidate 10 mg/day in the first month, 7.5 mg/day in the second month and 5 mg/day in the third month. The third group (25 people) matrix combination with methylphenidate and in the group control (25 people) there is no intervention.
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-10-14, 1396/07/22
Expected recruitment end date
2017-11-13, 1396/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two therapies methylphenidate and matrix-methylphenidate on the severity of addiction, craving and treatment abstinence in methamphetamine abusers
Public title
Comparison of the effect of two therapies methylphenidate and matrix-methylphenidate in methamphetamine abusers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
being at the age of 20 to 48 years
Methamphetamine dependence diagnoses accordingly Diagnostic and Statistical Manual of Mental Disorders fifth edition
the dominant use of methamphetamine for at least 3 months
Exclusion criteria:
Unwillingness to participate in the study
having severe psychotic disorders
Age
From 20 years old to 48 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Approval date
2017-10-12, 1396/07/20
Ethics committee reference number
IR.Kaums.REC.1396.59
Health conditions studied
1
Description of health condition studied
Methamphetamine Dependency
ICD-10 code
F15.15
ICD-10 code description
Other stimulant abuse with stimulant-induced psychotic disorder
Primary outcomes
1
Description
Addiction Severity
Timepoint
Before intervention and 4, 8 and 12 weeks after intervention
Method of measurement
Addiction Severity Index
Secondary outcomes
1
Description
Craving
Timepoint
Before intervention and 4, 8 and 12 weeks after intervention
Method of measurement
Visual cues inducing craving
Intervention groups
1
Description
The Matrix program, which consists of 22 sessions of cognitive and behavioral psychotherapy, will be performed weekly in two sessions of forty five minutes for 12 weeks.
Category
Behavior
2
Description
Methylphenidate ( Ritalin ) will be given 10 mg per day in first month, 7.5 mg per day for second month and 5 mg per day for third month
Category
Treatment - Drugs
3
Description
Combining matrix and methylphenidate treatment (The Matrix program, which consists of 22 sessions of cognitive and behavioral psychotherapy, will be performed weekly in two sessions of forty five minutes for 12 weeks and methylphenidate ( Ritalin ) will be given 10 mg per day in first month, 7.5 mg per day for second month and 5 mg per day for third month)
Category
Treatment - Other
4
Description
Control group (not receiving any psychological educational services and drugs)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Faraby Hospital Substance Dependency Clinic
Full name of responsible person
Nazanine Arian
Street address
Isar square, Farabi hospital, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
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, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdollah Omidi
Position
PhD of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
Email
omidi-a@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdollah Omidi
Position
PhD of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
Email
omidi-a@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdollah Omidi
Position
PhD of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
Email
omidi-a@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available