In this double blind (both patients, and researchers are blind to the medications) randomized (the patients are randomly located in one of the three arms. We use a standard randomization procedure), placebo controlled trial at least 60 hospitalized opioid dependent men are divided randomly into three groups (each group has at least 20 patients) and give 32 mg buprenorphine to first group, 16 mg buprenorphine to second group and placebo to third group as a single dose only. The patients will be followed up for at least 4 days and assess the anxiety, depression,suicidal thoughts and withdrawal symptoms by interview and also Hamilton anxiety, beck depression and suicidal thoughts questionnaires. The objective of this trials to find the best treatment dose of buprenorphine for reduction of withdrawal symptoms ,anxiety, depression and suicidal thoughts in opioid dependents and find the best choice.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082225160N11
Registration date:2017-09-10, 1396/06/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-10, 1396/06/19
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 Scirnces
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of different doses of buprenorphine (16,32 mg) on reduction of anxiety level and craving in opioid dependents
Public title
Assessment of effect of different doses of buprenorphine (16,32 mg) on reduction of anxiety level and craving in opioid dependents
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
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Both patients, and researchers are blind to the medications.
Randomization: in a double blind manner the patients are randomly located in one of the three arms. We use a standard randomization procedure generated by computer to have random sample set.
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 blvd
City
Shiraz
Postal code
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
IR.SUMS.MED.REC.1396.65
Health conditions studied
1
Description of health condition studied
Opioid dependency
ICD-10 code
ّF11
ICD-10 code description
Mental and behavioral disorders due to use of opioids
Primary outcomes
1
Description
change of withdrawal symptoms in opiod dependents and find the best choice
Timepoint
before the first dose and first day to 4 days
Method of measurement
by interview based on DSM-5 and questionnaire (Craving and withdrawal questionnaire)
Secondary outcomes
1
Description
Change of anxiety, depression in opiod dependents and find the best choice, suicidal thoughts
Timepoint
before the first dose and first day to 4 days
Method of measurement
by interview based on DSM-5 criteria and questionnaires (Ham-A, BSSI, BDI)
Intervention groups
1
Description
32 mg buprenorphine is given as a single dose to patients and evaluate anxiety, depression, suicidal thoughts and withdrawal symptom for at least 4 days.
Category
Treatment - Drugs
2
Description
16 mg buprenorphine is given as a single dose to patients and evaluate anxiety, depression, suicidal thoughts and withdrawal symptom for at least 4 days.
Category
Treatment - Drugs
3
Description
Placebo is given as a single dose to patients and evaluate anxiety, depression, suicidal thoughts and withdrawal symptom for at least 4 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
Vice chancellor of 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
Vice chancellor 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
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 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 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
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)