The objective of this randomized, triple-blind, placebo controlled study was to compare tramadol and methadone in the management of acute heroin withdrawal symptoms. Seventy heroin dependent outpatients received either methadone (60 mg/day) or tramadol (600 mg/day) for detoxification. Both drugs were continued for 3 days and then tapered 20% per 48 hours from initial dose. At the end of second week both drugs were discontinued. Severity of withdrawal symptoms was assessed five times at 4th, 6th, 8th, 10th, and 14th days by Objective Opioid Withdrawal Scale (OOWS). Side effects were also evaluated using checklist in each visit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138708261457N1
Registration date:2007-12-22, 1386/10/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2007-12-22, 1386/10/01
Registrant information
Name
Mehran Zarghami
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences and Department of Psychiatry, Mazandaran Univ
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 5659
Email address
mzarghami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences & Health Services
Expected recruitment start date
2007-12-22, 1386/10/01
Expected recruitment end date
2009-06-22, 1388/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Tramadol versus Methadone for the Management of Severe Heroin Withdrawal
Public title
Tramadol versus Methadone for the Management of Severe Heroin Withdrawal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: DSM-IV-TR criteria for opioids dependence, current heroin dependence (i.e. withdrawal symptoms), age more than 18 years old
Exclusion criteria: physical illness that needed tramadol and/or methadone consumption, using other substances except nicotine (other opioids, cannabinoids, alcohol and benzodiazepines etc.), major psychiatry disorders such as mood disorders (unipolar and bipolar), anxiety and psychotic disorders, major physical diseases such as hepatitis, tuberculosis, AIDS and so on, history of seizures
Age
From 18 years old to 65 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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, Vice Chancellor for Research
Street address
Building No 2, Mazandaran University of Medical Sciences, Moallem Square, Sari, Mazandaran, IR Iran
City
Sari
Postal code
4817844718
Approval date
2007-12-11, 1386/09/20
Ethics committee reference number
86-59
Health conditions studied
1
Description of health condition studied
Heroin Withdrawal
ICD-10 code
F11.3
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use (withdrawal state)
Primary outcomes
1
Description
management of heroin withdrawal
Timepoint
days 4, 6, 8, 10, 14
Method of measurement
Objective Opioid Withdrawal Scale (OOWS)
Secondary outcomes
1
Description
risk of respiratory depression
Timepoint
days 4, 6, 8, 10, 14
Method of measurement
physical examination and checklist
Intervention groups
1
Description
Methadone (60 mg/day) for 3 days and then the dose was gradually lowered (tapered 20% per 48 hours from the initial dose) until the end of 2nd week when it was discontinued
Category
Treatment - Drugs
2
Description
Tramadol (600 mg/day) for 3 days and then the dose was gradually lowered (tapered 20% per 48 hours from the initial dose) until the end of 2nd week when it was discontinued
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
addiction clinic of Zare hospital
Full name of responsible person
Dr. Mehran Zarghami
Street address
Zare Hospital, Neka Road
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Jalal Hoseini Mehr
Street address
Moallem Square
City
Sari
Grant name
10506
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?