This study is a randomized clinical trial on 30 patients abusing opioids who are candidates for treatment with NSAIDs due to having pain during their withdrawal period. After obtaining ethical approval and written informed consent form, patients will be devided into 2 groups after simple randomization. Subjects in group 1 will receive celecoxib 200 mg per day and participants in group 2 will be assigned to receive 1600 mg ibuprofen per day. 0-10 numeric pain scale and DDQ (Desire for Drug questionaire) are utilized to assess pain and craving of patients, at baseline and at the end of the treatment period (after 4 weeks). Questionnaires will be completed under the supervision of a clinical psychologist; data extraction and analysiswill be performed by a statistician.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609207202N11
Registration date:2016-10-31, 1395/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Padideh Ghaeli
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
pghaeli@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-04-10, 1395/01/22
Expected recruitment end date
2017-04-10, 1396/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effects of 4-week treatment of celecoxib and ibuprofen on craving of opioid abusers during the withdrawal period
Public title
Effects of celecoxib versus ibuprofen on craving in opioid abusers during withdrawal period
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age range 18-65; not using other NSAIDs during the trial; having abused opiates for at least six months
Exclusion criteria: pregnancy; lactation; suffering serious physical illnesses such as cancer, cardiovascular diseases, respiratory, cerebrovascular diseases and any thyroid disorder including Hypo or hyperthyroidism; People with other axis I psychiatric disorders and intellectual disability.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics committee of Pharmaceutical Sciences Research Center of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Keshavarz BLVD
City
Tehran
Postal code
Approval date
2016-05-11, 1395/02/22
Ethics committee reference number
IR.TUMS.REC.1395.2584
Health conditions studied
1
Description of health condition studied
Craving
ICD-10 code
F11.3
ICD-10 code description
Mental and behavioural disorders due to use of opioids withdrawal state
Primary outcomes
1
Description
craving
Timepoint
At baseline and 4 weeks after the initiation of the study
Method of measurement
Drug Desire Questionnaire (DDQ)
Secondary outcomes
1
Description
pain
Timepoint
At baseline and 4 weeks after the initiation of the study
Method of measurement
0-10 numeric pain rating scale
2
Description
other side effects of treatments
Timepoint
after 4 weeks of treatment
Method of measurement
Side Effect Check List
Intervention groups
1
Description
celecoxib capsule 200 mg orally daily for 1 month
Category
Treatment - Drugs
2
Description
ibuprofen, soft gel capsule 400 mg four times daily up to 1 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital Clinic
Full name of responsible person
Sana Khajehpour
Street address
Roozbeh Hospital, South Kargar Ave
City
Tehran
2
Recruitment center
Name of recruitment center
Tooska cessation camp
Full name of responsible person
Sana Khajehpour
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Reseach of Faculty of Pharmacy
Street address
Faculty of Pharmacy-Tehran University of Medical Sciences-16th Azar Street-Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Roozbeh Hospital
Full name of responsible person
Doctor Sara Jafari
Position
Doctor of Medicine, Psychology Speciality
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Ave
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
sarajafari76@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy of Tehran University of Medical Scienses
Full name of responsible person
Doctor Padideh Ghaeli
Position
Doctor of Pharmacy, Clinical Pharmacy Speciality
Other areas of specialty/work
Street address
Faculty of Pharmacy, Tehran University of Medical Sciences, 1 Azar St, Enqelab square
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
pghaeli@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ms. Sana Khajehpour
Position
Pharm.D Student
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
sanakhajehpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)