The goal of this study is to compare the effect of buprenorphine with methadone in reduction of methamphetamine craving. In this single blind trial 40 inpatients will be selected and by simple random sampling will be divided to two groups and each group includes 20 patients. Each group receives buprenorphine or methadone for a period of at least two weeks. We evaluate the craving of patients by interview and questionnaire every day to find more effective medication.
Inclusion criteria: Age between 18 to 50; They are free to participate in the study; Patient's major substance use be methamphetamine.
Exclusion criteria: Patients unwilling to participate at beginning or during the study; Use of another substance except Methamphetamine as of the main substance.
General information
Acronym
N/A
IRCT registration information
IRCT registration number:IRCT2015112125160N1
Registration date:2016-06-04, 1395/03/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-04, 1395/03/15
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
2016-02-01, 1394/11/12
Expected recruitment end date
2016-08-01, 1395/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the effect of buprenorphine and methadone in the reduction of methamphetamine craving
Public title
the effect of buprenorphine and methadone in the reduction of methamphetamine craving
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age: 18-50 ;informed consent; methamphetamine dependence
Exclusion criteria:Patients unwilling to participate at beginning or during the study; use of another substance except Methamphetamine as of the main substance.
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:
40
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Postal code
7194634786
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.SUMS.REC.1394.161
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 14 days
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
we will use methadone 40 mg po daily for one group for at least 14 days
Category
Treatment - Drugs
2
Description
we will use buprenorphine 8 mg po daily for the other group at least 14 days.
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, Hafeziye street
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, Zand Blvd
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
Profesor
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Street
City
Shiraz
Postal code
Phone
+98 71 3627 9319
Fax
+98 71 3627 9319
Email
jamshid_ahmadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Ahmadi
Position
professor
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Street
City
shiraz
Postal code
Phone
+98 71 3646 1511
Fax
Email
jamshid_ahmadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Ahmadi
Position
professor
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Street
City
Shiraz
Postal code
Phone
+98 71 3646 1511
Fax
+98 71 3627 9319
Email
jamshid_ahmadi@yahoo.com
Web page address
NA
Sharing plan
Deidentified Individual Participant Data Set (IPD)