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Investigation of Pramipexole’s possible efficacy to diminish liability to relapse of drugs of abuse: A double-blind randomized placebo-controlled study

Protocol summary

Study aim
Can pramipexole reduce the likelihood of relapse in the patients who are suffering from substance use disorder (stimulants) and what is the best tolerable dose and duration of therapy.
Design
Patients will be randomly assigned to two groups, one receiving pramipexole and the other a fully matched placebo.To keep the study double blind for researchers, staffs, and participants, masking will be kept throughout the study and all interventions will be dispensed by an off-site pharmacist.
Settings and conduct
Pramipexole will be started at 0.18 mg twice daily and gradually gone upward at weekly intervals to reach the desired therapeutic dose and will be maintained for 12 consecutive weeks. Patients will be assessed at baseline and each week for possible physical or mental problems, any noticeable adverse reaction, any co-medication and pregnancy. Urine and blood samples are taken from patients and will be examined for checking drug abuse metabolites by rapid test (the 1st, 3rd, and 6th month of the study as well as two times randomly during the study).
Participants/Inclusion and exclusion criteria
18-68 year old patients who have administered stimulants 2 times in the past month and are unable to abstain drugs for 2 times are entered. If patients have abused more than two drugs during the last 3 weeks or are pregnant/ breastfeed are disqualified.
Intervention groups
Pramipexole receiving patients and placebo receiving patients
Main outcome variables
Self-reported number of days of drug self-administration, number of days abstained from drugs, and the longest period that no addictive substance has been used. The frequency and intensity of craving and cue-induced reinstatement, Emergence of side effects, medication adherence, relative functionality, and mood.The number of consecutive negative urine tests, addiction severity index, and the periods of being stood away from any drugs of abuse.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190315043060N1
Registration date: 2019-05-04, 1398/02/14
Registration timing: prospective

Last update: 2019-05-04, 1398/02/14
Update count: 0
Registration date
2019-05-04, 1398/02/14
Registrant information
Name
Shokouh Arjmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3226 4196
Email address
s.arjmand@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of Pramipexole’s possible efficacy to diminish liability to relapse of drugs of abuse: A double-blind randomized placebo-controlled study
Public title
Pramipexole and relapse of stimulants abuse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patients who have administered stimulants (i.g. methamphetamine) at least 2 days in the past month. 2- Patients who have negative urine analysis for other addictive substances or the history of co-administration of drugs of abuse for no less than 3 weeks ago 3- Patients who meet the criteria of DSM-V for substance use disorder. 4- Patients who have failed to reduce or abstain currently abused substance at least for 2 times. 5- Patients who are seeking treatment and willing to abstain. 6- Age between 18 to 65 years 7- Patients who provide written informed consent. 8- Patients who have interest and are able to take part in a 4-month treatment phase and a 3-month follow up phase study (overall of 7 months). 9- Patients are only allowed to use pain killers, drugs used for neuropathic pain (gabapentin or pregabaline), and sleep aids (only benzodiazepines and Z-drugs)
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization of individual patients by a calculator-generated random number sequence (CASIO ClassPad 330) is used. Patients who receive 0 in randomization are assigned in the control group and those who receive 1 are allocated in the treatment group.
Blinding (investigator's opinion)
Double blinded
Blinding description
All interventions (pramipexole and its matched placebo) will be dispensed by an off-site pharmacist in fully-similar tablets identical in shape, color, and size sufficient for a 16 week-period. The allocation assignment for each treatment pack that has been sequentially numbered can only be accessible to the pharmacist.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Somaye interjunction, Ibn Sina street, Jahad BLVD
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.KMU.REC.1397.508

Health conditions studied

1

Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Other psychoactive substance related disorders

Primary outcomes

1

Description
Pramipexole's possible effects in reducing relapse of stimulants
Timepoint
1st, 3rd, 6th month of the study and 2 periods of random sampling
Method of measurement
Questionnaires, Urine samples, Self report

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pramipexole is started at 0.18 mg twice daily and is gradually titrated upward at weekly intervals to reach the desired therapeutic dose (i.e. the dose which is tolerable and cover the initial symptoms of withdrawal) and are maintained for 12 consecutive weeks. Dosing intervals are set the same for each intervention to maintain the study blind. Pramipexole is purchased from Osve Pharmaceuticals Co.
Category
Treatment - Drugs

2

Description
Control group: Placebo receiving groups are administered a fully matched placebo (size, color, and shape) twice daily at start for a 12-week period, that might be increased in a similar way to the treatment receiving group. Placebo is provided by Osve Pharmaceuticals.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital and Addiction Treatment Centers
Full name of responsible person
Zohre Zand Kargar
Street address
Jomhouri BLVD, Shahid Beheshti Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3211 1006
Email
zzohrehz657@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Vice-chancellor for research and technology
Street address
Sommaye Interjunction, Ebn Sina Street, Jahad BLVD, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
s.arjmand@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
41
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

2

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kerman Neuroscience Research Center
Street address
Somayye Interjunction, Ebn Sina Street, Jahad BLVD, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4196
Email
s.arjmand@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
59
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
Kerman University of Medical Sciences
Full name of responsible person
Shokouh Arjmand
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Somaye interjunction, Ibn Sina street, Jahad BLVD
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4196
Fax
Email
s.arjmand@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shokouh Arjmand
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Somaye interjunction, Ibn Sina street, Jahad BLVD
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4196
Fax
Email
s.arjmand@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zohre Zand Kargar
Position
Psychiatry Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Jomhouri BLVD, Shahid Beheshti Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 32111006
Email
zohrehz657@gmail.com

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
No - There is not 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
No - There is not 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 main outcomes and the final conclusion will be announced.
When the data will become available and for how long
When peer-review was completed and results were published.
To whom data/document is available
With permission of the research head, data can be هد شززثسس for those who ask for
Under which criteria data/document could be used
In case of a request to have access to the analyzed data, permission should be first sought, and the research team will decide on what further analyses are allowed, afterwards .
From where data/document is obtainable
Dr. Abdolreza Sabahi (abdsaba@kmu.ac.ir) Dr. Nouzar Nakhaee (nakhaeen@yahoo.com) Dr. Shokouh Arjmand (s.arjmand@kmu.ac.ir)
What processes are involved for a request to access data/document
In case of research team agreement, either raw and analyzed data are available within 2 months after the request is submitted.
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