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IRCT20260713070165N1 IRCT 2026-08-01 Yazd University of Medical Sciences Memantime in Opioid use Disorder Efficacy of Memantine vs Placebo as Adjunctive Therapy on Craving ،Impulsive Behaviors and Treatment Retention in Opioid Use Disorder Following Detoxification : a Randomized Double-blind Clinical Trial 2026-08-23 anticipated 80 Recruiting https://irct.ir/trial/92010 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Following confirmation of eligibility, acquisition of written informed consent, and completion of baseline assessments, participants will be allocated in a 1:1 ratio to receive either memantine or placebo. Individual-level stratified permuted-block randomization will be used. The stratification variables will include participant age, categorized as 18–39 years and 40–60 years, and duration of regular opioid use, categorized as less than 10 years and 10 years or longer. Accordingly, four strata will be formed. Within each stratum, an independent randomization sequence will be generated using randomly varying permuted block sizes of 4 and 6, with a 1:1 allocation ratio. The random allocation sequence will be generated before participant recruitment by an independent statistician using computer-based randomization software. Information regarding block sizes and sequence order will not be disclosed to members of the research team involved in participant recruitment, treatment administration, or outcome assessment. Memantine and placebo will be prepared and packaged in an identical manner by an independent pharmacist and labeled only with sequential numerical codes. Participants, treating physicians, outcome assessors, and investigators will remain blinded to treatment allocation until completion of the initial data analysis, Blinding description: Participants will be informed, before enrollment, about the nature of the trial, the possibility of receiving either memantine or placebo, and the 1:1 allocation ratio, and will provide written informed consent. However, they will remain unaware of their assigned intervention until completion of the initial data analysis. Memantine and placebo will be prepared, packaged, and coded by an independent pharmacist who will have no role in participant recruitment, clinical care, data collection, outcome assessment, or data analysis. The active medication and placebo will be made as similar as possible with respect to appearance, color, size, odor, packaging, and administration schedule. Participants in the placebo group will follow the same dose-escalation schedule as those in the memantine group, with corresponding stages matching the 7-, 14-, and 21-mg doses, to prevent the capsule-administration pattern from revealing treatment allocation. Medication packages will be labeled only with sequential numerical codes and will contain no information indicating the assigned intervention. The following individuals will remain blinded to participants’ treatment allocation: Participants; The principal investigator and other academic investigators involved in conducting the study; Outcome assessors, including personnel responsible for administering the Desire for Drug Questionnaire (DDQ), the delay-discounting task, the cue-induced craving task, and recording urine drug-screening results. The random allocation sequence will be generated by an independent statistician. For operational reasons, the statistician responsible for generating the sequence and the pharmacist responsible for coding the study medications will be aware of the correspondence between allocation codes and treatment assignments. However, neither individual will be involved in participant recruitment, treatment delivery, outcome assessment, or the primary data analysis. The code-identification list linking medication codes to treatment allocation will be stored in an encrypted electronic file or in sealed envelopes and will be accessible only to the independent pharmacist or another designated code custodian. During statistical analysis, the dataset will be provided to the analyst using neutral labels, such as “Group A” and “Group B.” The treatment codes will be revealed only after the database has been locked and the initial analysis of the prespecified outcomes has been finalized. Whenever feasible, the initial draft of the study results will also be prepared using these neutral group labels. 2-3 Opioid use disorder. Intervention 1: Intervention group: Memantine 21mg. Intervention 2: Control group: placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Maintaining the confidentiality and privacy of volunteers
public hossein ghadiry
shohadaie gomnam Boulevard, Shahid Sadoughi Medical Sciences Campus, Yazd
yazd Iran (Islamic Republic of) 8915173143 +98 35 3836 7636 hosineghadiry.2019@gmail.com Yazd University of Medical Sciences scientific hossein ghadiry
shohadaie gomnam Boulevard, Shahid Sadoughi Medical Sciences Campus, Yazd
یزد Iran (Islamic Republic of) 8915173143 +98 35 3836 7636 hosineghadiry.2019@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Individuals with a history of opium, opium extract (shireh), or heroin use who met the diagnostic criteria for opioid use disorder (OUD), had completed detoxification between 4 and 6 weeks prior to enrolment, and were receiving methadone maintenance treatment (MMT) at a stable dose Adults aged 18–60 years. Confirmation of OUD based on a clinical interview and completion of the SCID-II by an experienced psychiatrist, in accordance with the DSM-5 diagnostic criteria, with participants meeting at least 5 of the 11 DSM-5 criteria for OUD. Completion of the Mini International Neuropsychiatric Interview (MINI) by an experienced psychiatrist to assess psychiatric comorbidities, including depression and anxiety, and to confirm the absence of any severe psychiatric disorder. Negative urine drug screening results for amphetamines, methamphetamine, and cannabinoids. 18 years 60 years Both Severe hepatic, cardiac, or renal insufficiency. Severe neurological disorders, such as advanced dementia or multiple sclerosis (MS). Concomitant use of NMDA receptor antagonists, such as amantadine, ketamine, or high-dose dextromethorphan. Recent traumatic brain injury Pregnancy or breastfeeding. F11.2 Opioid use disorder Treatment - Drugs Placebo Intervention group: Memantine 21mg Control group: placebo Craving intensityConsumption. Timepoint: Before the start of the intervention and then every 2 weeks until the end of week 12. Method of measurement: Desires for Drug Questionnaire. Positive/negative methadone urine test. Timepoint: Before the start of the intervention and then every 2 weeks until the end of week 12. Method of measurement: Methadone urine test. Cue induced craving. Timepoint: Before the start of the intervention and then every 2 weeks until the end of week 12. Method of measurement: Visual sequence that stimulates drug use. Preference for immediate rewards over delayed rewards. Timepoint: Before the start of the intervention and then every 4 weeks until the end of week 12. Method of measurement: monetary choice questioner(MCQ) Kirby. Student personal expenses Approved 2026-07-13 Working Group/Research Ethics Committee, Faculty of Medicine - Shahid Sadoughi University of Medical shohadaie gomnam Boulevard - Shahid Sadoughi Medical Sciences Campus, Yazd yazd Yazd Iran (Islamic Republic of)