Aims: To evaluate the efficacy of gabapentin (1600 mg/day) as an adjunctive to methadone-assisted detoxification (MAD) in the treatment of opioid withdrawal symptoms. Design: A 3-week open label study. Setting: Specialized out-patient clinic for the treatment of patients with addictive disorders. Participants: 31 opiate addicts who met DSM-IV-TR criteria for opioid dependency. Intervention: adjunctive treatment with gabapentin (1600 mg/day) in addition to MAD for three weeks. Measurements: Subjective Opiate Withdrawal Scale (SOWS) with a total score of 0 to 64 will be administered at six time-points during the study.
General information
Acronym
G.T.O.D
IRCT registration information
IRCT registration number:IRCT138805102266N1
Registration date:2009-09-17, 1388/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-09-17, 1388/06/26
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 of Isfahan University of Medical Sciences.
Expected recruitment start date
2008-07-01, 1387/04/11
Expected recruitment end date
2008-12-15, 1387/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Gabapentin in the treatment of opioid withdrawal
Public title
Gabapentin in the treatment of opioid dependency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: opioid dependency ( based on DSM-IV-TR) for at least one year, stable dose of opium for at least one month prior to the study. Exclusion criteria: having a history of illicit drugs use other than opium, psychiatric medication and other substances use except cigarettes for a period of two months prior to the study, major psychiatric disorder, severe concurrent medical illness, organic brain disorder, mental retardation, pregnancy and lactation
Age
From 19 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Postal code
Approval date
empty
Ethics committee reference number
385113
Health conditions studied
1
Description of health condition studied
opium withdrawal
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Evaluation of total opium withdrawal symptoms severity
Timepoint
0(base line)and days of 3,7,10,14,18 after initiation of study
Method of measurement
Subjective Opiate Withdrawal Scale (SOWS)
Secondary outcomes
1
Description
evaluation of different withdrawal symptoms severity
Timepoint
0(base line)and days of 3,7,10,14,18 after initiation of study
Method of measurement
Subjective Opiate Withdrawal Scale (SOWS),
Intervention groups
1
Description
Adding Gabapentin 1600mg/day for 3 weeks to routine management
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Behavioral Sciences Research Center
Full name of responsible person
Gholam Reza Kheirabadi
Street address
Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Isfahan University of Medical Sciences
Full name of responsible person
Peiman Adibi
Street address
Isfahan University of Medical Sciences
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 of 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
Gholam Reza Kheirabadi
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Behavioral Sciences Research Center, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8145831451
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
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
Gholam Reza Kheirabadi
Position
Assistant Prof. of Psychiatry
Other areas of specialty/work
Street address
Behavioral Sciences Research Center, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8145831451
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
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
Gholam Reza Kheirabadi
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Behavioral Sciences Research Center, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8145831451
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)