Ear Acupuncture for Quitting Smoking and Stress Relief: a clinical study

Auricular Acupuncture for Smoking Reduction/Cessation and Emotional Disorders in smokers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-2db2syn

Enrollment

450

Registered

2026-03-12

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Tobacco Use Disorder

Interventions

This is an open-label, three-arm randomized controlled clinical trial. Participants will be randomized into three parallel groups: Control Group (n=150), receiving smoking reduction/cessation medicati

Experimental Group 1 (n=150), receiving auricular needle acupuncture with or without smoking reduction/cessation medication

and Experimental Group 2 (n=150), receiving laser auricular acupuncture with or without smoking reduction/cessation medication. Randomization will be performed by an individual external to the study

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals who consume at least one cigarette daily at the time of data collection; present preserved cognitive function; exhibit moderate to high levels of anxiety, stress, and/or depression (Depression, Anxiety, and Stress Scale — DASS-21) and fatigue (Fatigue Assessment Scale — FAS), or poor sleep quality (Pittsburgh Sleep Quality Index — PSQI); are residents of the municipalities or members of the university community in Viçosa; have time availability for evaluations and treatment sessions; agree to be randomly allocated to the study groups; of both genders; and are aged 18 years or older

Exclusion criteria

Exclusion criteria: Ear piercings, except in the earlobe; history of allergy to metal or microporous tape; history of photosensitivity; presence of lesions, inflammation, deformity, or tattoos on the ear; history of skin cancer in the head and neck region; use of hearing aids; use of chemical peels (retinoic acid, retinol, Vitanol-A, tretinoin, isotretinoin) and/or Roaccutane® (Isotretinoin) within six months prior to the start of treatment, due to their photosensitizing properties; immunocompromised individuals (e.g., undergoing cancer treatment or using immunosuppressants); epilepsy; use of a cardiac pacemaker; pregnant or lactating women, or those planning to become pregnant during the study period; rejection of or fear of receiving the technique; and undergoing any other concomitant energetic therapy during the study

Design outcomes

Primary

Measure	Time frame
A reduction in tobacco consumption patterns—comprising the degree of nicotine dependence and tobacco load based on the number of cigarettes consumed—is expected at the end of five weeks of treatment with either auricular needle acupuncture or laser acupuncture. This will be verified through the Fagerström Test for Nicotine Dependence (FTND), based on a variation of at least 1 point between pre- and post-intervention measurements (moderate to severe anxiety). The FTND consists of six questions addressing the user's difficulties regarding cigarette use. The total score is 10; thus, dependence is classified as: 0–2 points: very low; 3–4 points: low; 5 points: moderate; 6–7 points: high; and 8–10 points: very high. Tobacco load (TL) will be measured using data collected from participants' FTND through the formula: number of cigarettes consumed per day divided by 20 and multiplied by the number of years of smoking. The pack-year variable will be categorized as: TL less than 20 (light smoker), TL between 21 and 39 (moderate smoker), and TL greater than or equal to 40 (heavy smoker).;A reduction in anxiety levels is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Depression, Anxiety and Stress Scale (DASS-21), based on a variation of at least 5% between pre- and post-intervention measurements. The DASS-21 is an instrument composed of 21 items, which are distributed across the domains of anxiety, depression, and stress. Anxiety can be classified as follows: normal (0–7 points); mild (8–9 points); moderate (10–14 points); severe (15–19 points); and extremely severe (20 points or more). For this study, the cutoff point will be equal to or greater than 10 (moderate to severe anxiety).;A reduction in depression levels is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Depression, Anxiety and Stress Scale (DASS-21), bas	—

Measure

Time frame

A reduction in tobacco consumption patterns—comprising the degree of nicotine dependence and tobacco load based on the number of cigarettes consumed—is expected at the end of five weeks of treatment with either auricular needle acupuncture or laser acupuncture. This will be verified through the Fagerström Test for Nicotine Dependence (FTND), based on a variation of at least 1 point between pre- and post-intervention measurements (moderate to severe anxiety). The FTND consists of six questions addressing the user's difficulties regarding cigarette use. The total score is 10; thus, dependence is classified as: 0–2 points: very low; 3–4 points: low; 5 points: moderate; 6–7 points: high; and 8–10 points: very high. Tobacco load (TL) will be measured using data collected from participants' FTND through the formula: number of cigarettes consumed per day divided by 20 and multiplied by the number of years of smoking. The pack-year variable will be categorized as: TL less than 20 (light smoker), TL between 21 and 39 (moderate smoker), and TL greater than or equal to 40 (heavy smoker).;A reduction in anxiety levels is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Depression, Anxiety and Stress Scale (DASS-21), based on a variation of at least 5% between pre- and post-intervention measurements. The DASS-21 is an instrument composed of 21 items, which are distributed across the domains of anxiety, depression, and stress. Anxiety can be classified as follows: normal (0–7 points); mild (8–9 points); moderate (10–14 points); severe (15–19 points); and extremely severe (20 points or more). For this study, the cutoff point will be equal to or greater than 10 (moderate to severe anxiety).;A reduction in depression levels is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Depression, Anxiety and Stress Scale (DASS-21), bas

—

Secondary

Measure	Time frame
An improvement in sleep quality is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Pittsburgh Sleep Quality Index (PSQI), based on a variation of at least 5% between pre- and post-intervention measurements. The PSQI consists of 24 questions, 19 of which are self-rated by the participant and five answered by a bed partner or roommate. In this study, only the self-rated items will be considered. Each item is scored on a scale from zero to three points and covers the following components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, use of sleep medication, and daytime dysfunction. The total PSQI score ranges from 0 to 21 points, with scores above 5 indicating poor sleep quality.;An improvement in fatigue is expected at the end of five weeks of treatment with either auricular needle acupuncture or laser acupuncture. This will be verified through the Fatigue Assessment Scale (FAS), based on an observed variation of at least 5% between pre- and post-intervention measurements. The FAS consists of 10 items, scored on a five-point Likert scale ranging from one (never) to five (always). The total sum of the items results in a score ranging from 10 to 50 points, where higher values indicate greater fatigue intensity.;An improvement in the oxidative profile is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, based on a variation of at least 5% between pre- and post-intervention measurements. For the assessment of the oxidative profile, a prior appointment will be scheduled with participants for blood collection. The tubes will then be labeled, subjected to a centrifugation process to separate the serum, and stored at -20ºC. Subsequently, spectrophotometric analyses will be conducted. The evaluation of the oxidative profile will focus on quantifying biomarkers that indicate the balance between the pro	—

Measure

Time frame

An improvement in sleep quality is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Pittsburgh Sleep Quality Index (PSQI), based on a variation of at least 5% between pre- and post-intervention measurements. The PSQI consists of 24 questions, 19 of which are self-rated by the participant and five answered by a bed partner or roommate. In this study, only the self-rated items will be considered. Each item is scored on a scale from zero to three points and covers the following components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, use of sleep medication, and daytime dysfunction. The total PSQI score ranges from 0 to 21 points, with scores above 5 indicating poor sleep quality.;An improvement in fatigue is expected at the end of five weeks of treatment with either auricular needle acupuncture or laser acupuncture. This will be verified through the Fatigue Assessment Scale (FAS), based on an observed variation of at least 5% between pre- and post-intervention measurements. The FAS consists of 10 items, scored on a five-point Likert scale ranging from one (never) to five (always). The total sum of the items results in a score ranging from 10 to 50 points, where higher values indicate greater fatigue intensity.;An improvement in the oxidative profile is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, based on a variation of at least 5% between pre- and post-intervention measurements. For the assessment of the oxidative profile, a prior appointment will be scheduled with participants for blood collection. The tubes will then be labeled, subjected to a centrifugation process to separate the serum, and stored at -20ºC. Subsequently, spectrophotometric analyses will be conducted. The evaluation of the oxidative profile will focus on quantifying biomarkers that indicate the balance between the pro

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Countries

Contacts

Public ContactCaroline Moura

Universidade Federal de Viçosa

caroline.d.moura@ufv.br+55-31-998500059

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026