1. Home
  2. Approved trials
  3. » فارسی

Placebo-controlled randomized clinical trial testing the efficacy of desipramine in reducing craving in patients with methamphetamine use disorder

Protocol summary

Study aim
We will test the hypothesis that desipramine is effective in reducing methamphetamine craving in patients with the diagnosis of methamphetamine use disorder.
Design
A single-site double-blinded randomized placebo-controlled phase 2 trial on 40 patients
Settings and conduct
40 patients referring to the outpatient addiction clinic of Iran psychiatric hospital willing to receive matrix model therapy for methamphetamine addiction and willing to participate in the study who are eligible will be divided into two groups receiving desipramine or placebo for 12 weeks. An independent researcher will prepare the sequentially numbered envelopes with a code and the corresponding pills for the duration of the study. The corresponding researcher will allocate a participant to an unknown group based on the code and the containing of the opaque sealed envelop. The treatment team, the corresponding researcher and patients will all be blind to the allocated groups.
Participants/Inclusion and exclusion criteria
Male patients with the current diagnosis of methamphetamine use disorder aged 18 to 55 will be included. Patients will be excluded if: they have condition known to be deteriorated with desipramine use, have other psychiatric disorders requiring in patient care, have other medical conditions, have medication intolerance or they are not willing to continue participating.
Intervention groups
In the intervention group as the matrix model treatment begins, desipramine will be started at the dose of 50 mg per day and gradually increased to 100 mg per day and will be continued for 12 weeks. In the control group as the matrix model treatment starts, placebo will be administered in the same manner and continued for 12 weeks.
Main outcome variables
positive urine test for methamphetamine; visual analog scale score for craving; methamphetamine craving questionnaire-Brief score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160813029315N2
Registration date: 2019-06-27, 1398/04/06
Registration timing: retrospective

Last update: 2019-06-27, 1398/04/06
Update count: 0
Registration date
2019-06-27, 1398/04/06
Registrant information
Name
Mohammad Reza Najarzadegan
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 66535531
Email address
najarzadegan.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Behavioral Sciences Research Center of Iran University of Medical Sciences, Medical University of Iran University of Medical Science
Expected recruitment start date
2016-06-03, 1395/03/14
Expected recruitment end date
2017-03-03, 1395/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Placebo-controlled randomized clinical trial testing the efficacy of desipramine in reducing craving in patients with methamphetamine use disorder
Public title
The efficacy of desipramine in reducing methamphetamine craving
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 50 Current diagnosis of methamphetamine use disorder based on DSM IV-TR criteria Positive urine test for methamphetamine prior to study entry Male gender
Exclusion criteria:
Having conditions known to be deteriorated following desipramine use such as obesity, liver diseases, and cardiovascular diseases Taking antidepressants of any class in during the two weeks prior to entering the study Taking medications with potential effect on methamphetamine craving (i.e. modafinil, bupropion, naltrexone, N-acetylcysteine) Taking medications known to adversely interact with desipramine Serious mood disorders, suicidal ideation, and psychotic disorders requiring hospitalization Comorbid medical conditions, as revealed by history review, physical exam, or laboratory results of blood chemistry test and liver profile Incidence of a life-threatening side effect following medication use (i.e. liver failure, pancreatitis, hepatic encephalopathy, thrombocytopenia, leucopenia) Medication intolerance Use of other substances (except methadone maintenance therapy, nicotine, cannabis, and morphine) confirmed by a toxicology screen Currently (during a month prior to study) in treatment for methamphetamine use Having DSM IV-TR diagnosis of other substance use disorders in the past year No longer willing to participate in the study
Age
From 18 years old to 50 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
An independent researcher will randomly allocate eligible participants to treatment vs. placebo group by block randomization method with random block size using Random Allocation Software version 1.0.0. Generated codes with the associated pills (desipramine or placebo) will be inserted into opaque sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients, the corresponding researcher, physicians, nurses, people responsible to gather data, and individuals who evaluate outcomes will be blinded to the allocations.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
5th floor, central head quarter, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2015-06-25, 1394/04/04
Ethics committee reference number
IR.IUMS.REC 1394.92-11-28-6006

Health conditions studied

1

Description of health condition studied
Metamphetamine use disorder
ICD-10 code
F15.20
ICD-10 code description
Other stimulant dependence, uncomplicated

Primary outcomes

1

Description
Metamphemine craving
Timepoint
before intervention, at the end of each month after intervention until 4 months (0-1-2-3-4)
Method of measurement
Cocaine Craving Questionnaire-Brief

2

Description
Positive urine toxicology test for methamphetamine
Timepoint
Before intervention, at the end of each month after intervention until 4 months (0-1-2-3-4)
Method of measurement
Urine toxicology test

Secondary outcomes

1

Description
Drug Side Effects
Timepoint
Before intervention and at the end of each month after intervention until 4 months (0-1-2-3-4)
Method of measurement
Side effects questionnaire

Intervention groups

1

Description
Intervention group: Half of participants will be treated by desipramine (Exir pharmaceutical company) at the dose of 50 mg once per day orally and gradually increasing to 100 mg once per day and continued for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: Half of participants will receive placebo. Placebo will be started identically as the shape of desipramine with the dose of 50 mg once per day orally and gradually increased to 100 mg once per day and continued for 12 weeks. Placebo and desipramine will be of the same shape, appearance, size, texture, color, and odor.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Outpatient clinic of Iran psychiatry hospital
Full name of responsible person
Dr. Hamidreza Ahmadkhaniha
Street address
7th km Karaj road, Iran psychiatric hospital
City
Tehran
Province
Tehran
Postal code
١٣٩٨٩١٣١٥١
Phone
+98 21 4450 3395
Fax
+98 21 4450 3401
Email
iph.iranhospital@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mental Health Research Center
Full name of responsible person
Dr. Mehrdad Eftekhar
Street address
1st floor, Tehran Psychiatric Institute, Mansouri street, Niyayesh street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6650 6862
Fax
Email
mhrc@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mental Health Research Center
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
Iran University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Ahmadkhaniha
Position
Associate Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
7th km Karaj Special Road, Iran Psychiatric Hospital
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4452 5615
Fax
Email
dr_ahmadkhaniha@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Psychiatry department, Iran University of Mrdical Science
Full name of responsible person
Ila Daryoushfar
Position
Resident of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
7th km Karaj Special Road, Iran Psychiatric Hospital
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 6655 1515
Fax
Email
ila_darioushfar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr Ila Daryoushfar
Position
Resident of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
7th Km karaj road, Iran psychiatry hospital
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 6655 1515
Fax
Email
ila_darioushfar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The SPSS file containing data of participants is sharable.
When the data will become available and for how long
Data will be shared 6 months after publishing the results.
To whom data/document is available
Researchers could request to receive the data.
Under which criteria data/document could be used
Various analysis based of sample size is performable.
From where data/document is obtainable
To receive data one should email the corresponding researcher.
What processes are involved for a request to access data/document
Two weeks after an inquiry email one would receive the data.
Comments
Loading...