comparing the effect of Add-on Memantine to clonidine on severity of opioid substances (heroin and opium) withdrawal symptoms
Design
Randomized, Double- blind, placebo- controlled clinical trial
Addicts who referred are randomly assigning to one of two intervention or control groups (30 person in each group) using randomized block design (equal allocation of time intervals to the intervention and control groups)
Settings and conduct
All drug addicts referred to the outpatient withdrawal center of Khorshid Hospital in Isfahan are randomly divided into two groups of 30 each and treated with memantine or placebo (in addition to co-medications including clonidine and buprenorphine) (routine and current treatment). ). The drug administration is double-blind and the evaluator and patient will not be informed of the type of drug. The severity of withdrawal symptoms on days 1, 3, 7, and 21 will be assessed by a resident psychiatrist on a SOWS scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria:DSM-IV criteria for drug dependence.
Exclusion criteria: Non-use of psychiatric drugs and other substances other than cigarettes, Taking pain medications, Comorbid of major psychiatric disorders, Physical illness that is a prohibition on quitting drugs.
Intervention groups
The selected patients divided to two 30 groups.All of them undergoing an as usual treatment with buprenorhpine and randomly assigning in 2 groups of memantine and placebo as adding therapy (30 in each group).The severity of withdrawal symptoms in substance dependence on days 1,3,7,21is assessed by Short Opioid Withdrawal Scale(SOWS).
Main outcome variables
Reduce withdrawal symptoms by adding memantine to clonidine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090801002266N11
Registration date:2020-03-14, 1398/12/24
Registration timing:registered_while_recruiting
Last update:2020-03-14, 1398/12/24
Update count:0
Registration date
2020-03-14, 1398/12/24
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
Expected recruitment start date
2019-11-30, 1398/09/09
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Add-on Memantine to clonidine on severity of opioid substances (heroin and opium) withdrawal symptoms among opium users
Public title
efficacy of memantine on opioid substances withdrawal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
DSM-IV criteria for drug dependence
Regular and daily use of opium orally, injectable or smoke
Exclusion criteria:
Non-use of psychiatric drugs and other substances other than cigarettes
Taking pain medications
Comorbid of major psychiatric disorders
Physical illness that is a prohibition on quitting drugs.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
According to the sample size of 60 people, the samples will be selected in ten blocks of six.
Three person in each block will be randomly assigned to the first intervention group and three to the second intervention group, so that all six states of a six-block can be selected ten times randomly from the six blocks. By the end, thirty people will be randomly assigned to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants receive medication in unnamed drug packages and do not know if the drug is placebo or memantine.
The prescribing physician also does not know which patients receive placebo or memantine, and according to the list of random names of patients, the packages named A and B belong to the patients whose names are A and B, and to patients who receive Their names are given in the drug package.
Outcome assessor Unaware of the Patient's Drug, assess the severity of withdrawal symptoms using a questionnaire.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-11-30, 1398/09/09
Ethics committee reference number
IR.MUI.MED.REC.1398.450
Health conditions studied
1
Description of health condition studied
Opioid use disorder
ICD-10 code
F11
ICD-10 code description
Opioid related disorders
Primary outcomes
1
Description
severity of opium withdrawal
Timepoint
first, third, 7th, 10th and 21th days
Method of measurement
Short Opioid Withdrawal Scale(SOWS)
Secondary outcomes
empty
Intervention groups
1
Description
intervention 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. Its daily dose is gradually reduced by ten percent per day until discontinued.Memantine is manufactured by Tesminim Company of Iran and started at a dose of 10 mg daily (5 mg twice daily) as the dose of buprenorphine began to decrease and increased to 20 mg daily (twice daily at 10 mg). And lasts up to three weeks.
Category
Treatment - Drugs
2
Description
Control group: After discontinuation of the drug, buprenorphine is started in the first dose of 2-4 mg and gradually increased until complete control of withdrawal symptoms, after complete control of withdrawal symptoms with the last dose continued for 3-5 days and then daily dose. Gradually decrease by 10 percent per day until discontinued. Placebo is given to patients in equal numbers in appearance and taste similar to memantine (in collaboration with Isfahan Pharmacy School).
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
Behavioral Sciences Research Center, Khorshid hospital.,Ostandari Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2475
Email
info@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
HezarJerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
kheirabadi@bsrc.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Kheirabadi
Position
Assistant professor of Esfahan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of psychiatry of Isfahan University of Medical Sciences , Ostandari Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2475
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Kheirabadi
Position
Assistant professor of Esfahan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of psychiatry of Isfahan University of Medical Sciences , Ostandari Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2475
Email
kheirabadi@bsrc.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Kheirabadi
Position
Assistant professor of Esfahan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of psychiatry of Isfahan University of Medical Sciences , Ostandari Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD