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Evaluation the efficacy of Add-on Amantadine to clonidine on severity of opioid withdrawal symptoms.

Protocol summary

Study aim
Determining the effect of adding amantadine to clonidine on improving withdrawal symptoms of opioid 1- Determining and comparing the mean score of the Subjective Scale of Subjective Opioid Withdrawal Scale (SOWS) on days 1, 3, 7, 41 and 21 in the two groups of amantadine + clonidine and placebo + clonidine
Design
The type of this study is phase 3 double-blind clinical trial. The selected patients are assigned to the two treatment groups of clonidine + placebo and clonidine + amantadine in double random blocks. The sample size was calculated for 43 people in each group.
Settings and conduct
Patients referred to the addiction treatment center of Amin Hospital in Isfahan who use opium or heroin and are in the age range of 20-60 years and have DSM-V criteria in terms of substance dependence, by consecutive sampling and observing the inclusion criteria And exit will enter the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Satisfaction to participate in the study 2- Having DSM-V criteria for drug dependence Inclusion criteria: 1. Taking painkillers 2. Existence of major psychiatric disorders (by obtaining a psychiatric history according to DSM-5 criteria) or taking psychiatric medication
Intervention groups
The two intervention and control groups will receive amantadine and clonidine, or placebo and clonidine.In both groups, at the beginning of treatment, opioid is stopped abruptly and buprenorphine at a dose of 2-4 mg is started.The dose is then gradually increased until complete control of withdrawal symptoms. .
Main outcome variables
The process is such that both consecutive eligible entrants are considered as a block. The random mode is such that if the random number is 4-0, it is assigned to group A and if it is 5-9, it is assigned to group B, and then it is decoded from A and B according to the type of treatment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090801002266N15
Registration date: 2021-05-06, 1400/02/16
Registration timing: prospective

Last update: 2021-05-06, 1400/02/16
Update count: 0
Registration date
2021-05-06, 1400/02/16
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
2021-05-22, 1400/03/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of Add-on Amantadine to clonidine on severity of opioid withdrawal symptoms.
Public title
Efficacy of Add-on Amantadine to clonidine on severity of opioid withdrawal symptoms.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study Having DSM-V criteria for drug dependence Regular and daily consumption of opium and heroin orally, injected or smoked
Exclusion criteria:
The patient's unwillingness to continue cooperation Occurrence of any medical or moral conflict with the continued presence of the patient in the study Occurrence of physical and mental problems requires special interventions in the management of opioid withdrawal
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
Selected patients are randomly assigned to clonidine + placebo and clonidine + amantadine treatment groups.The process is such that both consecutive eligible entrants are considered as a block.The random method is such that if the random number is 4-0, it is assigned to group A and if it is 5-9, it is assigned to group B and then decodes A and B based on the type of treatment (in which drug group each patient was)
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention and control groups will receive amantadine and clonidine or placebo and clonidine, respectively. The drug is administered in a double-blind manner and the investigator and the patient will not know the type of drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences-School of Medicine
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-12-14, 1399/09/24
Ethics committee reference number
IR.MUI.MED.REC.1399.1147

Health conditions studied

1

Description of health condition studied
Severity of opioids withdrawal symptoms
ICD-10 code
F11.20
ICD-10 code description
Opioid dependence, uncomplicated

Primary outcomes

1

Description
the effects of amantadine in controlling of opioids withdrawal symptoms
Timepoint
The severity of withdrawal symptoms (initial outcome) on the first day (24 hours after the last dose of the drug) as a baseline assessment and then on days 3, 7, 14 and 21
Method of measurement
SOWS scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Clonidine + Amantadine, clonidine made with "drug manufacturing company" in Iran in 0.2 mg tablets and amantadine capsules made in Iran in Hakim Pharmaceutical Company. clonidine will be used in the same manner in both intervention and placebo groups. Amantadine will start with 100 mg daily and will be increased to 100 mg every 12 hours after one week. And Simultaneously with the cessation of the opioids component it will be increased to 300 mg per day (100 mg every 8 hours) and continues for up to three weeks.
Category
Treatment - Drugs

2

Description
Control group: Clonidine + placebo, clonidine made with "drug manufacturing company" in Iran in 0.2 mg tablets and placebo with similar appearance and taste (prepared in collaboration with Isfahan School of Pharmacy). clonidine will be used in the same manner in both intervention and placebo groups, placebo is also given to patients in the manner of amantadine.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Addiction Treatment Center of Amin Hospital, Isfahan
Full name of responsible person
Gholamreza Kheirabadi
Street address
Amin Hospital, Sanbolistan Alley, Isfahan, Ibn Sina St
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
kheirabadi@bsrc.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Kheirabadi
Street address
Vice chancellor for research, Isfahan University of Medical Sciences; Faculty of Medicine; Isfahan University of Medical Sciences; Hezar-Jarib Street; Isfahan; Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
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
Gholam Reza Kheirabadi
Position
Associate Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
Email
kheirabadi@bsrc.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholam Reza Kheirabadi
Position
Associate Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
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
Gholam Reza Kheirabadi
Position
Associate Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
Email
kheirabadi@bsrc.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Access range from 1400
To whom data/document is available
All academic researchers
Under which criteria data/document could be used
Analysis other than those listed in the method and research stage is not allowed.
From where data/document is obtainable
Correspondence by e-mail
What processes are involved for a request to access data/document
Request by e-mail with signature and statement of subject
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