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IRCT20190315043060N1 IRCT 2019-05-04 Kerman University of Medical Sciences Pramipexole and relapse of stimulants abuse Investigation of Pramipexole’s possible efficacy to diminish liability to relapse of drugs of abuse: A double-blind randomized placebo-controlled study 2019-05-22 anticipated 100 Complete https://irct.ir/trial/38489 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 0 (exploratory trials) Addiction. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The main outcomes and the final conclusion will be announced. When: When peer-review was completed and results were published. To whom: With permission of the research head, data can be هد شززثسس for those who ask for Conditions: 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 . Where to obtain: Dr. Abdolreza Sabahi (abdsaba@kmu.ac.ir) Dr. Nouzar Nakhaee (nakhaeen@yahoo.com) Dr. Shokouh Arjmand (s.arjmand@kmu.ac.ir) How to obtain: In case of research team agreement, either raw and analyzed data are available within 2 months after the request is submitted. Comments:
public Shokouh Arjmand
Somaye interjunction, Ibn Sina street, Jahad BLVD
Kerman Iran (Islamic Republic of) 7619813159 +98 34 3226 4196 s.arjmand@kmu.ac.ir Kerman University of Medical Sciences scientific Shokouh Arjmand
Somaye interjunction, Ibn Sina street, Jahad BLVD
Kerman Iran (Islamic Republic of) 7619813159 +98 34 3226 4196 s.arjmand@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) 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) 18 years 65 years Both F19 Other psychoactive substance related disorders Treatment - Drugs Placebo 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. 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. 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. Kerman University of Medical Sciences Kerman University of Medical Sciences Kerman University of Medical Sciences Approved 2019-03-12 Ethics Committee of Kerman University of Medical Sciences Somaye interjunction, Ibn Sina street, Jahad BLVD Kerman Kerman Iran (Islamic Republic of)