Guided Self-Change and Nicotine Replacement Therapy for Smoking Cessation

Efficacy of Guided Self-Change, Nicotine Replacement Therapy, and Their Combination for Smoking Cessation in Chronic Obstructive Pulmonary Disease Patients: A Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201609271457N11

Enrollment

Registered

2016-11-10

Start date

2016-12-19

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

Chronic Obstructive Pulmonary Disease. Chronic obstructive pulmonary disease with acute lower respiratory infection

Interventions

Intervention 1: The first intervention group: Nicotine replacement therapy(NRT) with nicotine gum.In this study, NRT was made to patients via transmucosally delivered nicotine polacrilex (nicotine gum

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Inclusion criteria

Inclusion criteria: Chronic Obstructive Pulmonary Disease Nicotine Dependency More than 45 years of age

Exclusion criteria

Exclusion criteria: Systemic Medical Diseases Normal Spirometry Contraindications or Precautions for Nicotine Gum Use

Design outcomes

Primary

Measure	Time frame
Smoking Cessation Rate. Timepoint: Before the treatment and every 3 weeks after treatment during 29 weeks. Method of measurement: Self-reported.	—

Secondary

Measure	Time frame
FEV1. Timepoint: Before the treatment and 6,12 and 29 weeks after treatment. Method of measurement: Spirometry Test.;Quality of Life. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: Quality of Life Questionnaire.;Behavioral Change. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: Trans Theoretical Model questionnaires (The stage of change,The processes of change,Temptation and Decisional balance).;Stress. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: The Questionnaire (Depression Anxiety Stress Scales).;Nicotine Dependency. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: The Questionnaire (Fagerstrom Test for Nicotine Dependency).;Pulmonary Function. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: The clinical Assessment Test (CAT).;The Exhaled Carbon Monoxide. Timepoint: Before the treatment and every 3 weeks after treatment. Method of measurement: Smokerlyzer.;Depression. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: Questionnaires(Hospital Anxiety and Depression Scale and Beck Depression Inventory).;Anxiety. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: Questionnaires(Hospital Anxiety and Depression Scale and Depression Anxiety Stress Scales).	—

Measure

Time frame

FEV1. Timepoint: Before the treatment and 6,12 and 29 weeks after treatment. Method of measurement: Spirometry Test.;Quality of Life. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: Quality of Life Questionnaire.;Behavioral Change. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: Trans Theoretical Model questionnaires (The stage of change,The processes of change,Temptation and Decisional balance).;Stress. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: The Questionnaire (Depression Anxiety Stress Scales).;Nicotine Dependency. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: The Questionnaire (Fagerstrom Test for Nicotine Dependency).;Pulmonary Function. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: The clinical Assessment Test (CAT).;The Exhaled Carbon Monoxide. Timepoint: Before the treatment and every 3 weeks after treatment. Method of measurement: Smokerlyzer.;Depression. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: Questionnaires(Hospital Anxiety and Depression Scale and Beck Depression Inventory).;Anxiety. Timepoint: Before the treatment and 12 and 29 weeks after treatment. Method of measurement: Questionnaires(Hospital Anxiety and Depression Scale and Depression Anxiety Stress Scales).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Taghizadeh

Mazandaran university of medical science

Fatemehtaghizadeh93@yahoo.com+98 11 3328 5109

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 20, 2026