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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201214049718N1

Enrollment

105

Registered

2021-01-25

Start date

2021-01-20

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with drug abuse, people treated with methadone. Drug abuse counseling and surveillance

Interventions

Intervention 1: Intervention group 1: In this group, patients will use three 3 mg melatonin tablets made by Razak company half an hour before bedtime for 4 weeks. In addition to melatonin, these patie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Amini

Esfahan University of Medical Sciences

zahraamini63@gmail.com+98 31 3274 7970

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026