We are going to compare the effects of pregabaline, gabapentine and placebo on the control of opioid dependence withdrawal symptoms. Inclusion criteria are: having DSM-V criteria for drug dependence; regular orally/smoking daily consumption of opium; using no other medication including psychiatric drugs and also other substances except cigarette; not taking pain medications; absence of other comorbid psychiatric disorders; not having any special disease which causes opium withdrawal prohibition; no contraindication for pregabalin and gabapentin consumption .Exclusion criteria are: lack of patients' interest for participation and continuation of study; any ethical or medical conflict for continuation; incidence of any physical/mental complication that needs special interventions.;pregnancy and breastfeeding. Study population includes all opium addicted persons who are referring to addiction treatment center of Khorshid Hospital in Isfahan, Sixty non-injecting opium users in the range of 20-50 years old who were diagnosed as opium dependent based on Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) will be select as the study sample based on inclusion and exclusion criteria from April to august 2017 . All of them undergoing an as usual treatment with buprenorhpine and randomly assigning in 3 groups of gabapentine, pregabalin and placebo as adding therapy (20 in each group). The severity of withdrawal symptoms will be evaluated in first, 7th, 15th and 22th days using SOWS by a resident of psychiatry.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707252266N7
Registration date:2017-08-10, 1396/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-10, 1396/05/19
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 chancelor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of Pregabalin and gabapentin on the control of opioid withdrawal symptoms
Public title
comparisson of gabapentne and pregabalin in controling of opioid withdrawal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having DSM-V criteria for drug dependence; regular orally/smoking daily consumption of opium; using no other medication including psychiatric drugs and also other substances except cigarette; not taking pain medications; absence of other comorbid psychiatric disorders; not having any special disease which causes opium withdrawal prohibition; no contraindication for pregabalin and gabapentin consumption .
Exclusion criteria : lack of patients' interest for participation and continuation of study; any ethical or medical conflict for continuation; incidence of any physical/mental complication that needs special interventions.
;pregnancy and brestfeeding.
Age
From 20 years old to 50 years old
Gender
Both
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of medical sciences
Street address
Isfahan
City
Isfahan
Postal code
Approval date
2017-03-10, 1395/12/20
Ethics committee reference number
IR.MUI.REC.396.1396.3.117
Health conditions studied
1
Description of health condition studied
Opium Dependency
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
severity of opium withdrawal
Timepoint
first, 7th, 15th and 22th days
Method of measurement
Qustionair
Secondary outcomes
1
Description
drugs sideffects
Timepoint
first, 7th, 15th, 22th days
Method of measurement
check list
Intervention groups
1
Description
pregabalin group:patients in this groups will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day.
Pegabalin produced by sobhan darou Tehran,Iran will be started with dose of 150mg in the first week and the dose will be increased to 300mg for next week. Finally in 3rd and 4th weeks patients will be recieve 450mg of pregabalin/day.
Category
Treatment - Drugs
2
Description
Gabapentine group: patients in this groups will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day.
We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day.
Gabapentine produced by sobhan darou Tehran,Iran will be started with dose of 400 mg/day in the first week, 800mg in second week and the dose will be increased to 1600mg in 3rd and 4th weeks
Category
Treatment - Drugs
3
Description
Placebo group: patients in this groups al so will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day.
Placebo produced by department of pharmacology in Isfahan University of medical sciences will be started and continued in the same manner of gabapentine and pregabalin groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Addiction treatmen centre of Khorshid Hospital
Full name of responsible person
Gholam Reza kheirabadi
Street address
Depoartment of Psychiatryy, Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Nematbakhsh
Street address
Vice chancelor for resaerch of Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
396117
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Gholam Reza Kheirabadi
Position
Psychiatrist
Other areas of specialty/work
Street address
Department of psychiatry, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3222 2135
Fax
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Kheirabadi
Position
Psychiatrist
Other areas of specialty/work
Street address
Department of psychiatry, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3222 2135
Fax
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Kheirabadi
Position
Psychiatrist
Other areas of specialty/work
Street address
Department of psychiatry, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3222 2135
Fax
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)