The effect of adding perphenazine to matrix treatment program on the craving and relapse in methamphetamine users compared with placebo
Design
This study is a double-blind randomized controlled clinical trial.
Individuals will be screened for inclusion criteria using clinical psychiatric interview and physical examination.
All participants will complete a written informed consent form . All participants will be randomly assigned to the perphenazine and placebo groups after randomization.
Both groups will be treated with a 2-month Matrix program and then followed up for a 4-month period.
Settings and conduct
participants will include those who will be referred to the Isfahan Welfare Organization for treatment by participating in the Matrix Therapy Program with a diagnosis of methamphetamine use disorder.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Having DSM-V-based methamphetamine dependency criteria
2- Not using other other substances at the same time
3- Not using other psychiatric drugs at the same time
Exclusion criteria:
1-Not wanting to continue cooperation for any reason
2- Psychiatric p
Intervention groups
In the intervention group, perphenazine starts at 8 mg / day and then, if the craving to methamphetamine persists, increases 8 mg / week to reach the final dose of 32 mg / day and continued until the end of the intervention.
The placebo in control group prescribes and continues with the same drug form and same protocol as perphenazine.
Main outcome variables
Assessment of craving for and return to methamphetamine use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090801002266N13
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
2019-11-22, 1398/09/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding perphenazine to Matrix intervention on control of craving and relapse in methamphetamine users
Public title
The effect of perphenazine on methamphetamine dependence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Methamphetamine use disorder criteria based on DSM5
Ages 18 to 50 years
Dependence only on methamphetamine
Non-pregnancy and lactation
Lack of psychosis or severe mood disorder requiring hospitalization
Non-simultaneous use of other substances
Non-simultaneous use of psychiatric medicines
Exclusion criteria:
Unwillingness to continue collaborating during the study
Psychiatric problems requiring hospitalization during the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by available sampling method based on inclusion and exclusion criteria and will be randomly assigned to one of two intervention or control groups after obtaining written consent.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not be aware of the type of drug they are taking, and the drugs will be given in separate packages, and the shape and color of the drugs and the placebo will not be identifiable.
Individuals who perform the intervention process and control the recovery process will also not be aware of the allocation of patients to the intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of esfahan University of Medical Sciences
Street address
vicechancelor for research , Isfahan University of Medical Sciences, Hezarjerib St. Isfahan Iran
City
esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-08-26, 1398/06/04
Ethics committee reference number
ir.mui.med.rec.1398.228
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: In the intervention group, buprenorphine will be started in a sublingual form (made by Mehr Pharmaceutical Company) at 2 mg daily and increase to 4 mg / day (2 sublingual tablets) over a 7-day period and Continue for 1 month and then gradually discontinue within 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: In control group, placebo (similar to buprenorphine 2 mg tablet prepared by the Faculty of Pharmacy) starts sublingual with one tablet daily and will be increased to 2 tablets per day and then continued for one month. And then it gradually declined and stopped within two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital and wellfaer esfahan
Full name of responsible person
Dr.Gholamreza kheirabadi
Street address
Ostandari street
City
Esfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 21 3532 2231
Fax
+98 21 3532 2231
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
Ostandari street
City
Esfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 21 3532 2231
Fax
+98 21 3532 2231
Email
khrirabadi@bsrc.mui.ac.ir
Grant name
reseach deputy of esfahan university of medical sciences
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
Gholamreza kheirabadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ostandari street
City
Esfahan
Province
Isfehan
Postal code
8145831451
Phone
0098 21 352223198
Fax
+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 khrirabadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ostandari street
City
Esfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 21 3532 2231
Fax
+98 21 3532 2231
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
Gholamreza kheirabadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ostandari strret
City
Esfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2135
Fax
+98 31 3222 2135
Email
khirabadi@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