Protocol summary

Summary
In this double blind trial 60 hospitalized opioid dependent men are randomly divided into three groups (each group has 20 patients) and give 32 mg buprenorphine to first group, 64 mg buprenorphine to second group and 96 mg buprenorphine to third group as a single dose only. The patients will be followed up for two weeks and evaluate the withdrawal symptoms, depression and suicidal thoughts by interview and also beck depression and suicidal thoughts questionnaires. The goal of this study is to find the best treatment dose of buprenorphine for reduction of withdrawal symptoms, depression and suicidal thoughts in opiod dependents and find the best choice.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071325160N4
Registration date: 2017-01-24, 1395/11/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-24, 1395/11/05
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
2016-06-21, 1395/04/01
Expected recruitment end date
2018-02-22, 1396/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of different doses of Buprenorphine (32 mg- 64 mg- 96 mg) on the reduction of opioid withdrawal symptoms and reduction of their depression and suicidal thoughts
Public title
Effect of Buprenorphine on reduction of withdrawal symptoms, depression and suicidal thoughts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:age between 16 to 60 y/o; informed consent;Opioid dependence Exclusion criteria:Patients unwilling to participate at beginning or during the study; use of other substances except Opioid as of the main substance.
Age
From 16 years old to 60 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
ice Chancellery for Research Affairs, Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Postal code
7194634786
Approval date
2016-08-21, 1395/05/31
Ethics committee reference number
IR.SUMS.REC.1395.102

Health conditions studied

1

Description of health condition studied
Opioid dependency
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids

Primary outcomes

1

Description
reduction of depression in opiod dependents and find the best choice
Timepoint
before the first dose and first day to 14 days
Method of measurement
interview and questionnaires

2

Description
reduction of withdrawal symptoms in opiod dependents and find the best choice
Timepoint
before the first dose and first day to 14 days
Method of measurement
interview and questionnaire

3

Description
reduction of suicidal thouhgts in opiod dependents and find the best choice
Timepoint
before the first dose and first day to 14 days
Method of measurement
interview and questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
32 mg buprenorphine is given as a single dose to patients and evaluated withdrawal symptoms, depression and suicidal thoughts for two weeks.
Category
Treatment - Drugs

2

Description
64 mg buprenorphine is given as a single dose to patients and evaluated withdrawal symptoms, depression and suicidal thoughts for two weeks.
Category
Treatment - Drugs

3

Description
96 mg buprenorphine is given as a single dose to patients and evaluated withdrawal symptoms, depression and suicidal thoughts for two weeks.
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
ice 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
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

2

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyyed Basir Hashemi
Street address
ice 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
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
Proffesor
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
7194654743
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 of Psychiatry, Director of Substance Abuse and Mental Health Research Center
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Street
City
Shiraz
Postal code
7194654743
Phone
00
Fax
Email
jamshid_ahmadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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