The aim of current study is to assess the effects of pregabalin on opiate withdrawal syndrome in a clinical-trial. This study will be conducted on thirty patients, including 28 males and 2 females. Main inclusion criterion is being drug-dependent based on DSM-V criteria. Patients will be divided into two groups through decussate method based on visiting time. Intervention group will receive pregabalin and control one will be treated with placebo. Pregabalin will be started at the dose of 150mg/day in the first week and the dose will be increased to 300mg/day for second week. Finally in 3rd and 4th weeks, patients will administer 450mg/day and since then, pregabalin will be tapered. Placebo is produced in the same shape as pregabalin, by Pharmacy Faculty, Isfahan University of Medical Sciences. Patients in both groups are under bupronorphine treatment at first. Bupronorphine dose will be adjusted based on patients need and also will be tapered during first week of study. Patients' evaluation is based on Short Opioid Withdrawal Scale (SHOWS) including 10 questions on physical and mental symptoms/signs. They are scored from 0 (no symptoms/signs) to 3 (symptoms/signs). The assessment will be performed through interview by a psychiatry resident. Evaluation will be started before intervention and will be proceeded for 4 weeks of pregabalin use. Adverse effects of pregabalin will be assessed as well.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702012266N6
Registration date:2017-04-11, 1396/01/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-11, 1396/01/22
Registrant information
Name
Gholamreza Kheirabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2135
Email address
kheirabadi@bsrc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of adding Pregabalin to daily treatment regimen in reducing withdrawal symptoms in opioid dependent patients
Public title
Pregabalin effect on opioid withdrawal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being drug dependent based on DSM-V criteria; regular oral/smoking daily consumption of opium; using no other medication including psychiatric drugs and also other substances except cigarette; not using pain medications; absence of other comorbid psychiatric disorders; not having any special diseases in which addiction treatment is prohibited; no contraindication for pregabalin consumption; no use of any other medication interacting with pregabalin.
Exclusion criteria: lack of patients' interest for participation in the study.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not 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
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St, Isfahan, Iran
end of 1st week, end of 2nd week, end of 3rd week and end of 4th week
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Pregabalin tab, oral administration, 150mg/day in 1st week, 300mg/day in 2nd week and 450mg/day in 3rd and 4th weeks
Category
Treatment - Drugs
2
Description
Control group: placebo tab, oral administration, one tab for 1st week, 2 tabs for 2nd week and 3 tabs for 3rd and 4th weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor and Ali-Asghar Hospital
Full name of responsible person
Dr. Shahryar Moazeni
Street address
Psychiatric Department, Nour and Ali-Asghar Hospital, Ostandari Street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Shahryar Moazeni
Street address
Vice chancellor for research, Isfahan University of Medical Sciences; Faculty of Medicine; Isfahan University of Medical Sciences; Hezar-Jarib Street; Isfahan; Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Shahryar Moazeni
Position
resident of psychiatry
Other areas of specialty/work
Street address
Department of Psychiatry, Noor and Ali-Asghar Hospital, Ostandari Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3222 2475
Fax
Email
shahryar.m1984@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Shahryar Moazeni
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Department of Psychiatry, Noor and Ali-Asghar Hospital, Ostandari Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3222 2475
Fax
Email
shahryar.m1984@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Scienses
Full name of responsible person
Dr. Shahryar Moazeni
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Psychiatric Department; Nour and Ali-Asghar Hospital; Ostandari Street; Isfahan; Iran
City
Isfahan
Postal code
Phone
0089312222475
Fax
Email
shahryar.m1984@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)