With respect to the issue that all published articles about the comparison of opium tincture and methadone syrup are open labeled, we decide to compare the effects of opium tincture and methadone syrup for management of acute opium withdrawal symptoms in a randomized double blind clinical trial.
Seventy four opium dependent females or males with the age range of 18 to 60 years old will be included if they have no history of serious medical or psychiatric disorders. Patients will be randomly allocated to methadone syrup or opium tincture and received methadone (15, 30 and 45 mg ) or opium Tincture (45, 90 and 135 mg ) according to the severity of dependence based on Addiction Severity Index. Methadone (15, 30 and 45 mg ) or Opium Tincture (45, 90 and 135 mg ) will be administered for the patients, respectively. Both drugs will be continued with fix dose for 5 days and then be tapered 20% per day. At the end of tenth day both drugs will be discontinued. Appearance and odor of both drugs will be equalized by pharmaceutical industry experts. Patients and rater are blind to the drugs. Severity of withdrawal symptoms will be assessed daily by Objective Opioid Withdrawal Scale (OOWS). Adverse effects will be assessed by direct question and observation. Data will be analyzed by SPSS software. Comparison will be done by T-test and Chi-square. Major analysis of questionnaire‘s scores will be done by Repeated Measures Analysis of variance.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122511885N1
Registration date:2013-07-01, 1392/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-01, 1392/04/10
Registrant information
Name
Samaneh Farnia
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3328 5659
Email address
sfarnia@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2012-11-08, 1391/08/18
Expected recruitment end date
2013-03-08, 1391/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of opium tincture and methadone syrup for management of acute opium withdrawal.
Public title
Opium tincture and methadone syrup effectiveness for management of opium withdrawal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Meeting the DSM-IV-TR criteria for opium dependence; first time detoxification; age range 18- 60 years .
Exclusion criteria: Physical illnesses that needed methadone consumption; using other substances (other opioids, cannabinoids, alcohol, benzodiazepines and etc); major psychiatric disorders such as bipolar mood disorder, major depression, severe anxiety disorders and psychotic disorders; major physical diseases such as hepatitis, tuberculosis, AIDS and etc; pregnancy; lactation.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The block randomization method is used . Since the taste ,appearance and odor of both drugs is equalized patients and rater are blind to them.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
4817844718
Approval date
2012-11-07, 1391/08/17
Ethics committee reference number
91-121
Health conditions studied
1
Description of health condition studied
opium 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
opium withdrawal sign & symptom
Timepoint
Daily (Within 10 days of drug administration)
Method of measurement
Objective Opioid Withdrawal Scale (OOWS)
Secondary outcomes
1
Description
Side effects of drugs
Timepoint
Daily (Within 10 days of drug administration)
Method of measurement
Questionnaire
Intervention groups
1
Description
In methadone group, regarding to a severity of dependence )Based on Addiction Severity Index( mild, moderate, severe, methadone syrup (Made by Exir Company) 15, 30 and 45 mg may be administered, respectively. Drug was continued in two divided doses for 5 days with a constant dose and then tapered 20% per day. At the end of Tenth Day drug was discontinued.
Category
Treatment - Drugs
2
Description
In Tincture of Opium group, regarding to a severity of dependence )Based on Addiction Severity Index( mild, moderate, severe, Tincture of Opium (Made by Daroupakhsh Company) 45, 90 and 135 mg may be administered, respectively. Drug was continued in two divided doses for 5 days with a constant dose and then tapered 20% per day. At the end of Tenth Day drug 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
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
10506
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran University of Medical Sciences