Effect of Melatonin in smoking cessation in COPD patients

Investigating the efficacy of Melatonin in smoking cessation in patients with COPD: A triple-blind randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190810044500N25

Enrollment

Registered

2024-07-30

Start date

2024-08-03

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

smoking cessation in COPD patients. Other chronic obstructive pulmonary disease

Interventions

Intervention 1: Intervention group: Melatonin. A group of patients receives 5 mg melatonin tablets according to the table of random numbers. Patients are asked to take one tablet at night before going

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 75 years old or younger with COPD stage I and II according to gold criteria with COPD confirmation for at least 12 months Smoking at least ten cigarettes a day during the last year Desire to quit smoking Adequate literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects

Exclusion criteria

Exclusion criteria: Mental illnesses such as major depression, panic disorder, bipolar disorder diagnosed by a psychiatrist or clinical psychologist History of alcoholism or substance abuse disorder within 12 months prior to study screening Use of medications that interfere with the effectiveness of study medications (such as nicotine replacement therapy) BMI less than 18.5 or greater than 34.9 Pregnancy or breastfeeding or tendency to become pregnant during the study

Design outcomes

Primary

Measure	Time frame
Continuous abstinence rate. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: clinical examination.;Addiction to smoking. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Fagerström test.;Number of cigarettes consumed daily. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: clinical examination.;Time of the first cigarette in the morning. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: clinical examination.	—

Measure

Time frame

Continuous abstinence rate. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: clinical examination.;Addiction to smoking. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Fagerström test.;Number of cigarettes consumed daily. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: clinical examination.;Time of the first cigarette in the morning. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: clinical examination.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegin Haddad

Yazd University of Medical Sciences

negin.haddad79@gmail.com+98 35 3820 3419

Outcome results

None listed

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