Aims evaluation of the efficacy of topiramate in patient undergoing treatment for opiate withdrawal. Design a two-week double-blind, randomized, placebo-controlled of adjunctive topiramate in methadone-assisted detoxification(MAD). Setting Specialized Addictive Behaviors Unit (Ibn-e-Sina hospital), an in-patient unit for the treatment of patients with an addictive disorder serving the city of Mashhad (Iran). Participants forty in-patients, all males aged 20-61 years, who met DSM-IV criteria for opiate dependence. Intervention random assignment of subjects to receive adjunctive treatment with either topiramate ( 100 mg/day) or placebo under double-blind conditions. Measurements Severity of subjective withdrawal symptoms using the Subjective Opiate Withdrawal Scale at five stages.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307205280N14
Registration date:2013-08-02, 1392/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-02, 1392/05/11
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2013-04-04, 1392/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding topiramate (compared to placebo) in reducing withdrawal symptoms in opium-like substances in the substance-dependent patients
Public title
The effect of adding topiramate (compared to placebo) in reducing withdrawal symptoms in opium-like substances in the substance-dependent patients
Purpose
Treatment
Inclusion/Exclusion criteria
Individuals are included if they fulfil DSM-IV-TR criteria for opioid- like substance dependency. However, Patients are not included if they have opioid- like withdrawal syndrome during the recruitment period.
Exclusion criteria: concomitant use of alcohol, stimulants as well as benzodiazepines; having severe medical comorbidities; patients who start to take any psychiatric medication or any significant change in dose of medication during the study and follow-up period.
Age
From 19 years old to 59 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Tehran
City
Tehran
Postal code
Approval date
2012-03-10, 1390/12/20
Ethics committee reference number
1068
Health conditions studied
1
Description of health condition studied
opioid withdrawal symptoms
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids