Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00148

2 Trial Registration Date

2008-01-17

i Registration Status

Prospective

3 Secondary IDs

ICM/CTS/07/344

4 Source(s) of Funding

Institute of Chinese Medicine

5 Primary Sponsor

Department of Psychiatry

6 Secondary Sponsor

Department of Anaesthesia and Intensive Care, School of Public Health, Department of Chemical Pathology, Institute of Chinese Medicine

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ellie Pang

ii Address

Institute of Chinese Medicine, CUHK

iii Phone

Tel:2252 8736

iv Email

email: elliepang@cuhk.edu.hk

v Affiliation

ICM, CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Ellie Pang

ii Address

Institute of Chinese Medicine, CUHK

iii Phone

Tel:2252 8736

iv Email

email: elliepang@cuhk.edu.hk

v Affiliation

ICM, CUHK

vi Country

9 Official Scientific Title of the Study

Pilot Study of Acupressure for smoking cessation

10 Public Title

Pilot Study of Acupressure for smoking cessation

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-12-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Current smokers and are motivated to quit smoking

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Auricular and Hand Acupressure

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Total 4 weeks, included 3 week treatment and 1 week observation

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Sham Acupressure

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: Current smokers and are motivated to quit smoking

ii Exclusion Criteria

Exclusion criteria: Aged less than 18 years, Currently having smoking cessation therapy including nicotine replacement therapy, psychological therapy and behavioural therapy, Have contraindications to ear or hand acupressure, Mentally incompetent or refuse to consent to the study

iii Age Minimum

18

iv Age Maximum

No Upper Limit

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-02-01

21 Target Sample Size

90

22 Recruitment Status

Complete

23 Primary Outcome

Successful quit smoking rates at three weeks, as measured by self-report and carbon monoxide in expired air analyses.

24 Secondary Outcome

Reduction in the number of cigarettes smoked/day, rating of withdrawal sympotms using the Mood and Physical Symptoms Scale and adverse effects associated with the intervention at three week.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-20

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000709

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2011-02-08