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Harmonizing Mind Acupuncture Combined with Nicotine Replacement Therapy for Tobacco Use Disorder: A Randomized Controlled Trial

Harmonizing Mind Acupuncture Combined with Nicotine Replacement Therapy for Tobacco Use Disorder: A Randomized Controlled Trial Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000683
Enrollment
Unknown
Registered
2026-03-23
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Tobacco Use Disorder

Interventions

Intervention group:Harmonizing Mind Acupuncture (30 minutes per session, 3 times per week, for 6 weeks, total 18 sessions), combined with Nicotine Replacement Therapy (NRT patch, once daily, dosage ba
Control group: Nicotine Replacement Therapy (NRT patch, once daily, dosage based on smoking history)

Sponsors

The Affiliated Hospital of Yunnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Ages 18–60 years, either sex; meets DSM-5 diagnostic criteria for Tobacco Use Disorder (TUD); smokes =10 cigarettes per day with a smoking history =1 year; has a clear intention to quit and is willing to receive nicotine replacement therapy; has not received any acupuncture-related treatment within the past 3 months; is able to understand the study's purpose and procedures and provide written informed consent; commits to cooperating with the intervention and follow-up schedule throughout the study; and volunteers to participate and signs written informed consent.Voluntary participation with signed written informed consent.

Exclusion criteria

Exclusion criteria: Presence of severe or decompensated cardiovascular, respiratory, hepatic, renal, or other major systemic diseases; active severe gastrointestinal disorders or malnutrition; severe or unstable psychiatric conditions (e.g., active psychosis, major depressive episode, manic phase) or significant cognitive impairment; pregnancy, lactation, or intention to become pregnant during the study; infection, open wounds, scars, or other contraindications at the acupuncture sites; current participation in any other treatment or study that could interfere with this intervention or outcome assessment; history of allergy or serious adverse reactions to nicotine patches.

Design outcomes

Primary

MeasureTime frame
Nicotine craving intensity (Visual Analogue Scale, VAS);

Secondary

MeasureTime frame
7-day Point Prevalence Abstinence (PPA);Exhaled Carbon Monoxide (CO);Quality of Life (SF-36 questionnaire);Sleep quality (Pittsburgh Sleep Quality Index, PSQI);Depression symptoms (Beck Depression Inventory-II, BDI-II);Anxiety symptoms (Beck Anxiety Inventory, BAI);

Countries

China

Contacts

Public ContactChuanxiong Li

Department of Rehabilitation Medicine, The Affiliated Hospital of Yunnan University

352784777@qq.com18313871217

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jul 18, 2026