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IRCT20261018071471N1 IRCT 2026-10-19 Islamic Azad University The Effects of Opium Tincture Administered Through a Stepwise Gradual Reduction Method and Methadone on Sexual Function DST,MMT Divergent Effects of Opium Tincture Step-down Tapering (DST) versus Methadone Maintenance Treatment (MMT) on Sexual Function in Men with Opium Use Disorder: Evidence from a Comparative Trial 2026-01-24 anticipated 70 Complete https://irct.ir/trial/94187 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Randomization Method: Simple randomization. Four study groups were formed, and the four study conditions, including gradual stepwise treatment (DST), cognitive behavioral therapy (CBT), methadone maintenance treatment (MMT), and the control condition, were subsequently assigned to the groups by lottery. Randomization Unit: Study group. Randomization Tool: Lottery using paper slips bearing the names of the treatment conditions and the control condition. Random Sequence Generation: After the four participant groups had been formed, the names of the four study conditions, namely gradual stepwise treatment, cognitive behavioral therapy, methadone maintenance treatment, and the control condition, were written on separate paper slips. Each condition was then assigned to one of the four groups through a lottery-based procedure. Allocation Concealment: In this study, the treatment conditions were allocated to the groups through a lottery-based procedure. No separate procedure for allocation concealment was implemented apart from the lottery process. 3 opioid sexual dysfunction. Intervention 1: Intervention group: Gradual Stepwise Reduction. Intervention 2: Intervention group: Methadone Maintenance Treatment (MMT). Intervention 3: Intervention group: Cognitive Behavioral Therapy (CBT). Intervention 4: Control group: control. Yes - There is a plan to make this available What will be shared: The data are recorded in written form on paper. When: Access will begin six months after publication. To whom: Researchers employed at academic and scientific institutions. Conditions: There are no other specific conditions Where to obtain: l.shabani.156@gmail.com How to obtain: Please contact us only via email. Comments:
public Dr.Ali.Shaker
Department of Psychology, School of Humanities, Urmia Branch, Islamic Azad University, Urmia, West Azerbaijan Province, Iran
Urmia Iran (Islamic Republic of) ۵۷۱۶۹-۶۳۸۹۶ +98 44 3344 0094 Ali.shaker2000@gmail.com Islamic Azad University scientific Ali Skaker Dolgh
Department of Psychology, School of Humanities, Urmia Branch, Islamic Azad University, Urmia, West Azerbaijan Province, Iran
Urmia Iran (Islamic Republic of) ۵۷۱۶۹۶۳۸۹۶ +98 44 3344 0094 Ali.shaker2000@gmail.com Islamic Azad University Iran (Islamic Republic of) Opium dependence diagnosed through a clinical interview in accordance with the DSM-5-TR criteria male gender being married absence of severe psychotic disorders or cognitive impairment no history of simultaneous participation in other similar treatment programs provision of informed consent and commitment to regular attendance o use of pharmaceutical medications outside the assigned treatment protocol 20 years 65 years Male Severe psychotic disorders or cognitive impairment a history of concurrent participation in other similar treatment programs use of pharmaceutical medications outside the assigned treatment protocol F11.181 Opioid abuse with opioid-induced sexual dysfunction Treatment - Drugs Treatment - Drugs Treatment - Drugs Other Intervention group: Gradual Stepwise Reduction Intervention group: Methadone Maintenance Treatment (MMT) Intervention group: Cognitive Behavioral Therapy (CBT) Control group: control Total score on the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES), comprising 19 items and three subscales: Recognition, Ambivalence, and Taking Steps. Responses are rated on a five-point Likert scale. Higher scores indicate greater readiness to change addictive behaviors. Timepoint: Three assessments: baseline (before the intervention), post-test (immediately after completion of the three-month treatment period), and follow-up (at a specified interval after treatment completion). Method of measurement: Self-report questionnaire completed by the participant in the presence of the researcher/therapist. Total score on the International Index of Erectile Function (IIEF), comprising 15 self-report items across five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Total scores range from 0 to 75, with higher scores indicating better sexual functioning. Timepoint: Three assessments: baseline (before the intervention), post-test (immediately after completion of the three-month treatment period), and follow-up (at a specified interval after treatment completion). Method of measurement: Self-report questionnaire completed by the participant in the presence of the researcher/therapist. Total score on the Brief Self-Control Scale (BSCS), comprising 13 self-report items. Total scores range from 13 to 65, with higher scores indicating greater self-control/behavioral self-regulation. Timepoint: Three assessments: baseline (before the intervention), post-test (immediately after completion of the three-month treatment period), and follow-up (at a specified interval after treatment completion). Method of measurement: Self-report questionnaire completed by the participant in the presence of the researcher/therapist. I had no source of funding. Approved 2026-04-21 The Respected Ethics Committee of the Islamic Azad University, Urmia Branch Department of Psychology, School of Humanities, Urmia Branch, Islamic Azad University, Urmia, West Azerbaijan Province, Iran Urmia West Azarbaijan Iran (Islamic Republic of)