Effect of Buprenorphine Addition to Matrix Therapy Compared to Placebo on Prevention of Recurrence of methamphetamine use.
Design
This study is a double-blind randomized controlled clinical trial
Settings and conduct
The study sample will be peoples afflicted with methamphetamine use disorder ( based on DSM-V criteria) who will be referred to outpatient clinic of addiction Treatment Center of khorshid hospital in Isfahan for participating in "Matrix treatment program".
Individuals will be screened for inclusion criteria using clinical psychiatric interview and physical examination.
Oral explanation will be represent about the design, purpose, duration of the study, types of medications and probable risks and then a written informed consent form will be completed by participants.
participants will be randomly assigned to either the buprenorphine or placebo groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) ages of 18-60 years
2) Having the DSM-V criteria for methamphetamine use disorder
3) It is dependent only on methamphetamine
4) No pregnancy and lactation
Exclusion criteria:
1) Any psychiatric disorder that require hospitalization
2) unstable medical condition.
3) Any drug side effects that the person does not tolerate continued medication use.
Intervention groups
For the intervention group, buprenorphine will be started in a sublingual form at 2mg daily and increased to 4mg / day (2 sublingual tablets) over a 7-day period and continued for 1 month and then gradually discontinue within 2 weeks.
In the control group, placebo is administered to patients with a similar drug form of buprenorphine (to be provided sublingual by the Faculty of Pharmacy) and lasts up to 1 month and then gradually discontinue within 2 weeks..
Main outcome variables
Reduction of relapse in methamphetamine-dependent patients following the use of buprenorphine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090801002266N12
Registration date:2020-03-17, 1398/12/27
Registration timing:registered_while_recruiting
Last update:2020-03-17, 1398/12/27
Update count:0
Registration date
2020-03-17, 1398/12/27
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
2019-08-23, 1398/06/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of add on buprenorphine vs. placebo on reduction of relapse among people with Met Amphetamine dependency during Matrix program
Public title
buprenorphine efficacy in methamphetamin dependency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) People 18-60 years old 2)Having the DSM-V criteria for methamphetamine use disorder 3) It is dependent only on methamphetamine 4) No pregnancy and lactation
Exclusion criteria:
1)Any psychiatric disorder that require hospitalization 2) Medical condition that interfere with participating in the study 3)Any side effect that interfere with continuation of buprenorphin
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Given the sample size of 40 people, Sampling will be done in ten blocks of four, In each block, two individuals will be randomly assigned to the intervention group and two to the control group, so that all six states of a four-block may be selected ten times randomly from the six blocks. By the end, twenty people in each group will be randomly assigned blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the study did not know whether they would take the drug placebo.
Principal investigators are also blinded to this, and the drug and placebo are provided in code-packs by the person who is not directly involved in the study.
People who are evaluating and recording the study outcomes are also unaware that the patient has received the drug or the placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
etic commeettee of Isfahan University of Medical Sciences
Street address
vicechancelor for research , Isfahan University of Medical Sciences, Hezarjerib St. Isfahan Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.MUI.MED.REC.1398.243
Health conditions studied
1
Description of health condition studied
Methamphetamine use disorder
ICD-10 code
F10-F19
ICD-10 code description
Mental and behavioral disorders due to use of other stimulants, including caffeine
Primary outcomes
1
Description
substance use craving
Timepoint
weeks 1-8 and 12,16,20,and 24
Method of measurement
questionair
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: buprenorphine In the intervention group, buprenorphine will be started in a sublingual form (made by Mehr Pharmaceutical Company) at a dose of 2 mg daily and increased to 4 mg daily (2 sublingual tablets) over a 7-day period and continued for 1 month. And then gradually discontinue within 2 weeks. Patients will be evaluated by urine methamphetamine test and CCQ-Brief questionnaire at the time of each week during intervention and after the 1 month in follow-up period
Category
Treatment - Drugs
2
Description
Control group: placebo In the control group, placebo with the same form as buprenorphine (prepared by the Faculty of Pharmacy) would be used in sublingual and with a similar protocol to the intervention group for up to 1 month. and similar to the intervention group they would be assessed with a urine amphetamine test and a CCQ-Brief questionnaire weekly at the time of intervention and monthly during the follow-up period
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid Hospital- هسبشاشد
Full name of responsible person
Gholamreza Kheirabadi
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2135
Fax
+98 31 3222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 4, Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfarayen 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
Gholamreza Kheirabadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Khorshid Hospital, Ostandari St. Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81458-31451
Phone
+98 31 3222 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
gholamreza kheirabadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Khorshid hospitalm, Ostandari St, Isfahan, iran
City
Esfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2135
Fax
+98 31 3222 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
Dr Gholam Reza Kheirabadi
Position
Psychiatrist/ Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Khorshid hospital
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
Email
kheirabad@bsrc.mui.ac.ir
Web page address
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