The goal of this study is comparing the effects of Buprenorphine and Bupropion in the reduction of Methamphetamine craving. The study population are Methamphetamine dependent individuals and the study is designed single blind for the patients. Sixty patients whom are between 18 to 50 years old and meet the criteria for Methamphetamine Dependence based on DSM-IV-TR will enter the study after signing the informed consent. The patients will be divided into two groups by random sampling method which is stratified for age and gender, and one group will receive Buprenorphine 4mg tablets twice a day for one month and the other group will receive Bupropion 150mg tablets twice a day for the same period. The craving for Methamphetamine will be assessed daily by the Methamphetamine craving questionnaire and the craving levels will be compared by T-Test and Chi Square Test between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010320540N1
Registration date:2015-04-10, 1394/01/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-10, 1394/01/21
Registrant information
Name
Mehdi Biuseh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3640 6460
Email address
biusehm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences research budget
Expected recruitment start date
2015-01-25, 1393/11/05
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Bupropion and Buprenorphine on the reduction of craving in Methamphetamine dependent hospitalized patients
Public title
Comparing the effects of Bupropion and Buprenorphine on the reduction of Methamphetamine craving
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 50 years old ; Informed Consent ; The main substance is Methamphetamine. Exclusion criteria: Dissatisfaction at the start or anytime during the research ; The main substance is something except Methamphetamine.
Age
From 18 years old to 50 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz university of Medical Sciences, Zand street, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2014-07-26, 1393/05/04
Ethics committee reference number
92-01-01-6693
Health conditions studied
1
Description of health condition studied
Methamphetamine Dependency
ICD-10 code
F 15.2
ICD-10 code description
Mental and behavioural disorders due to use of other stimulants, including caffeine : dependence syndrome
Primary outcomes
1
Description
Methamphetamine Craving Level
Timepoint
Daily
Method of measurement
Methamohetamine Craving Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive Buprenorphine 4mg tablets twice a day for 2weeks to 1month.
Category
Treatment - Drugs
2
Description
Control group will receive Bupropion 150mg tablets twice a day for 2weeks to 1month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne Sina hospital
Full name of responsible person
Mehdi Biuseh
Street address
Ebne Sina hospital, Hafez street, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr.Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz, Iran
City
Shiraz
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 of 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, Shiraz, Iran
Full name of responsible person
Prof .Ali Sahraian
Position
Professor
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3230 5884
Fax
Email
sahraian@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Prof. Ali Sahraian , Prof.Jamshid Ahmadi
Position
Professor, Full Professor
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3230 5884
Fax
Email
sahraian@sums.ac.ir ; jamshid_ahmadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Prof. Ali Sahraian
Position
Professor
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3230 5884
Fax
Email
sahraian@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)