The effect of melatonin on sleep quality, mental health and performance in patients with drug abuse in methadone-treated patients

Phase 3

Recruiting

Conditions: Patients with drug abuse, people treated with methadone.
Drug abuse counseling and surveillance
Z71.5

Registration Number: IRCT20201214049718N1

Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 105

Inclusion Criteria

Willingness to participate in research
Over 18 years of age
Having writing literacy
Substance abuse confirmed by positive urine tests
PSQI score above 5
No neurological, neuro-psychotic or autoimmune disease, cancer, lung disease, class 4 heart failure or unstable angina
No taking benzodiazepines, anticonvulsants, aspirin, beta-blockers, calcium channel blockers, NSAIDs, dexamethasone, lithium, melatonin, and antidepressants such as serotonin reuptake inhibitors.
Not working in night shift
Taking methadone for at least 3 months

Exclusion Criteria

If there is a crisis or un foreseeable disaster during the research.
Changes in treatment protocol for any reason before the intervention
Sever allergic reaction to melatonin and zolpidem
Pregnancy or Lactation

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep Quality Score in Petzburg Sleep Quality Questionnaire. Timepoint: Before and 4 weeks after intervention. Method of measurement: Petzburg Sleep Quality Questionnaire.;Mental health score in Depression, Anxiety, Stress Scale-21. Timepoint: Before and 4 weeks after intervention. Method of measurement: Depression, Anxiety, Stress Scale-21.;Sexual function score in Internation Index of Erectile Function Questionnaire. Timepoint: Before and 4 weeks after intervention. Method of measurement: Internation Index of Erectile Function Questionnaire.;General health score in General Health Questionnaire-28. Timepoint: Measurement of general health score before the intervention and 4 weeks after the taking of melatonin or zolpidem or placebo. Method of measurement: General Health Questionnaire-28.

Secondary Outcome Measures