Investigating the effect of rosemary on anxiety, depression, sexual disorders, sleep and cognitive disorders of patients undergoing maintenance treatment with methadone

Phase 3

• Conditions: Opioid related disorders; F41.9; F32.9; Anxiety disorder, unspecified; Major depressive disorder, single episode, unspecified; Unspecified sexual dysfunction not due to a substance or known physiological condition; Sleep disorder, unspecified; Mental and behavioural disorders due to use of opioids : residual and late-onset psychotic disorder; F11.7; Condition 1: drug abuse. Condition 2: Anxiety. Condition 3: depression. Condition 4: sexual dysfunction. Condition 5: Sleep disorder. Condition 6: Cognitive disorders.

• Registration Number: IRCT20240429061589N1
• Lead Sponsor: Kerman University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Age between 18 and 60 years
Proficiency in Persian language
Literacy for reading and writing
Methadone maintenance treatment

Exclusion Criteria

No history of heart disease
No diabetes
Absence of liver and kidney failure
Absence of pregnancy
Epilepsy and life-threatening diseases
Lack of chronic treatment with antidepressants
Not receiving antidepressants, benzodiazepines, melatonin and other sleep medications during the past month
Not having moderate to severe mental disability
No history of allergic reaction to rosemary and similar products

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety. Timepoint: Immediately before the beginning of the study and after the end of the intervention (fourth week). Method of measurement: Hospital Anxiety and Depression Scale (HADS).;Sexual disorders. Timepoint: Immediately before the beginning of the study and after the end of the intervention (fourth week). Method of measurement: changes in sexual functioning questionnaire (csfq-14).;Cognitive impairment. Timepoint: immediately before the beginning of the study and after the end of the intervention (fourth week). Method of measurement: Montreal Cognitive Assessment.;Sleep disorder. Timepoint: Immediately before the beginning of the study and after the end of the intervention (fourth week). Method of measurement: Pittsburgh Sleep Quality Index (PSQI).;Depression disorder. Timepoint: immediately before the beginning of the study and after the end of the intervention (fourth week). Method of measurement: Hospital Anxiety and Depression Scale (HADS).