Determination and comparison of the effects of different doses of buprenorphine on treatment of methamphetamine users in patients admitted
Design
The goal of study is to compare the effect of deiffrent dosses of Buprenorphine on methamphetamine dependency treatment. in this single trial at least 60 patient will be selected and by simple random sampling (sortiton ) will be divided to 3 group and each group include 20 patients. each group recives one dose of Buprenorphine from deiffrent dooses (0.1,1,8)mg QD
Settings and conduct
The questionnaire is asked daily for 4 days in ebne sina hospital
Participants/Inclusion and exclusion criteria
Induction criteria: 1)Age 18-50 2)Inform consent 3)Methamphetamine depanced; Exclusion criteria: 1)Patient unwilling to participle at beginning or during the study 2)Use of another substance except Methamphetamine as of the main substance
Intervention groups
The questionnaire asked daily and it shows the effect of drug and this medicine isn't have side effect
Main outcome variables
Carving
General information
Reason for update
Acronym
N/A
IRCT registration information
IRCT registration number:IRCT20170715035094N4
Registration date:2019-03-07, 1397/12/16
Registration timing:retrospective
Last update:2019-03-07, 1397/12/16
Update count:0
Registration date
2019-03-07, 1397/12/16
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 3070
Email address
bazrafshan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Equipment and items to be purchased: 200 buprenorphine ,each one is 10,000 Rials, totally 2,000,000 Rials ,Travel costs: Taxi vehicle, each time is 50,000 Rials , two person, totally 6,000,000
Rials ,copy writing costs: 2,000,000 RIals
Expected recruitment start date
2017-11-03, 1396/08/12
Expected recruitment end date
2018-10-04, 1397/07/12
Actual recruitment start date
2018-01-24, 1396/11/04
Actual recruitment end date
2018-11-11, 1397/08/20
Trial completion date
2019-03-12, 1397/12/21
Scientific title
Compering the effect of different doses of buprenorphine on methamphetamine dependency treatment
Public title
The effect of buprenorphine on methamphetamine dependency treatment
1)patient unwilling to participle at beginning or during the study,
2)use of another substance except Methamphetamine as of the main substance
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this double-blind study 60 patients are selected and with using the computer generated random sampling program, these 60 people are divided into 3 groups of 20 people.This computer program will automatically divide these 60 people into three groups of 20 people completely randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researchist; Emulator Analyzer; Participant don't know about doses of drugs and groups during test
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
Shiraz University of Medical Science , Znad Blvd
City
Shiraz
Province
Fars
Postal code
7194634786
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
IR.SUMS.MED.REC.1396.64
Health conditions studied
1
Description of health condition studied
Methamphetamine Dependency
ICD-10 code
F19
ICD-10 code description
Other psychoactive substance related disorders
Primary outcomes
1
Description
Craving
Timepoint
Before starting the intervention and daily for 4 days after starting the drug
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Depression
Timepoint
Before starting the intervention and daily for 4 days after starting the drug
Method of measurement
Questionnaire
2
Description
Suicide
Timepoint
Before starting the intervention and daily for 4 days after starting the drug
Method of measurement
Questionnaire
3
Description
Anxiety
Timepoint
Before starting the intervention and daily for 4 days after starting the drug
Method of measurement
Questionnaire
4
Description
Withdrawal
Timepoint
Before starting the intervention and daily for 4 days after starting the drug
Method of measurement
Questionnaire
Intervention groups
1
Description
We will use Buprenorphine 0.1 mg po QD for one group at least 14 days
Category
Treatment - Drugs
2
Description
We will use Buprenorphine 8 mg po QD for one group at least 14 days
Category
Treatment - Drugs
3
Description
We will use Buprenorphine 1 mg po QD for one 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
Amir Bazrafshan M.d
Street address
Ebne Sina Hospital, Hafeziye street
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3228 0236
Email
sinahosp@sums.ac.ir
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 Siences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3481 4336
Email
info@sums.ac.ir
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Amir Bazrafshan M.D
Position
M.D
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hafez Hospital, Abiverdi street
City
Shiraz
Province
Fars
Postal code
719434786
Phone
+98 71 3627 9319
Fax
Email
bazrafshan_amir@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
Amir Bazrafshan M.D
Position
M.D
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hafez Hospital, Abiverdi street
City
Shiraz
Province
Fars
Postal code
7194534786
Phone
+98 71 3627 9319
Fax
Email
bazrafsham_amir@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
Amir Bazrafshan M.D
Position
M.D
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hafez Hospital, Abiverdi street
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3627 9319
Fax
Email
bazrafshan_amir@yahoo.com
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