Comparison of the efficacy of different doses of buprenorphine (8mg, 2mg) on the reduction of methamphetamine withdrawal symptoms, depression, suicidal thought and anxiety.
The aim of this trial is to compare the effect of buprenorphine (8mg, 2mg) in reduction of methamphetamine craving, depression, suicidal thought and anxiety. In this double blind trial at least 66 inpatients will be selected and by random sampling will be divided to three groups and each group includes at least 22 patients. Each group receives buprenorphine 8 mg or 2 mg or placebo for a period of at least five days. We evaluate the craving of patients by interview and questionnaire every day to find more effective medication. Inclusion criteria: Age between 18 to 60; 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
IRCT registration information
IRCT registration number:IRCT2017081525160N8
Registration date:2017-08-25, 1396/06/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-25, 1396/06/03
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
2017-08-15, 1396/05/24
Expected recruitment end date
2018-10-16, 1397/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of different doses of buprenorphine (8mg, 2mg) on the reduction of methamphetamine withdrawal symptoms, depression, suicidal thought and anxiety.
Public title
Comparison of the efficacy of different doses of buprenorphine (8mg, 2mg) on the reduction of methamphetamine(crystal, Shishe) withdrawal symptoms, depression, suicidal thought and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age: 18-60 ;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 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand blvd
City
Shiraz
Postal code
7194634786
Approval date
2017-08-01, 1396/05/10
Ethics committee reference number
IR.SUMS.REC
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, depression, suicidal thoughts and anxiety
Timepoint
Daily for 5 days
Method of measurement
Questionnaire and interview
Secondary outcomes
empty
Intervention groups
1
Description
We will use buprenorphine 8mg sublingual daily for one group for at least 5 days
Category
Treatment - Drugs
2
Description
We will use buprenorphine 2 mg sublingual daily for the other group at least 5 days.
Category
Treatment - Drugs
3
Description
We will use placebo sublingual daily for one group for at least 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
EbneSina Hospital
Full name of responsible person
Jamshid Ahmadi M.D
Street address
EbneSina Hospital, Hafeziye street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
SeyedBasirHashemi
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
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 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 M.D.
Position
Professor
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Street
City
Shiraz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)