Effect of melatonin supplementation in treatment of maintenance methadone treatment patients

A Clinical trial to assess the effect of melatonin supplementation compared with the placebo on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017072933551N3

Enrollment

Registered

2017-08-17

Start date

2017-08-03

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Addiction. Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances

Interventions

Intervention 1: Intervention group: Melatonin supplements (NUTRALab, Scarborough, Canada), 5 mg, two oral capsules, one hour before bedtime for 12 weeks. Intervention 2: Control group: Placebo oral ca

Eligibility

Sex/Gender

Male

Age

25 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients on maintenance methadone treatment Age of 25 to 70 years

Exclusion criteria

Exclusion criteria: Taking melatonin, multivitamin-mineral and antioxidant supplements during the last 3 months before the intervention Taking anti-inflammatory agents History of metabolic diseases including diabetes, hypertension, thyroid and cardiovascular disease

Design outcomes

Primary

Measure	Time frame
Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.	—

Secondary

Measure	Time frame
HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Depression beck score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Anxiety beck score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Expressed levels of LL-1 gene. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: PCR.;Expressed levels of LL-8 gene. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: PCR.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: PCR.;Expressed levels of PPAR-?. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: PCR.;Total glutathione. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Depression beck score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Anxiety beck score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Expressed levels of LL-1 gene. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: PCR.;Expressed levels of LL-8 gene. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: PCR.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: PCR.;Expressed levels of PPAR-?. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: PCR.;Total glutathione. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Spectrophotometry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026