Smoking Reduction Intervention for Smokers Not Willing to Quit Smoking: a Randomised Control Trial

Smoking Cessation Clinical Trial

Official title:

Smoking Reduction Intervention for Smokers Not Willing to Quit Smoking: a Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563329
• Other study ID #: UW 03-103 T/103
• Secondary ID: HARECCTR0500051
• Status: Completed
• Phase: N/A
• First received: November 21, 2007
• Last updated: October 22, 2013
• Start date: October 2004
• Est. completion date: July 2006

Study information

• Verified date: October 2013
• Source: Hospital Authority, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aims of this study are (1) to examine the effect of smoking reduction intervention (reduction counseling and nicotine replacement therapy, NRT) (a) on smoking cessation and (b) on reducing daily cigarette consumption among smokers not willing to quit smoking but want to reduce smoking, and (2) to examine the effect of adherence intervention in producing a higher (a) adherence rate, (b) reduction rate, and (c) quit rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3826
• Est. completion date: July 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or above

• Ethnic Chinese male or female

• Smokes at least 2 cigarettes per day

• Have no intention to quit in the near future

• Intends to reduce smoking in the next 7 days

• Has no contraindication to NRT

Exclusion Criteria:

• Subjects who are psychologically or physically unable to communicate

• Children and teenagers (age below 18)

• Pregnant or intention to become pregnant within the next 6 months

• Those on regular psychotropic medications and in the presence of any serious health problems that may make them unsuitable for using NRT, such as recent stroke, palpitation, or other life threatening conditions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Procedure:
• Reduction Intervention + Adherence Intervention

Behavioral:
• Reduction Intervention

Procedure:
• control

Locations

Country	Name	City	State
China	HAHO	Hong Kong
China	Hong Kong Council on Smoking and Health	Hong Kong
China	The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong	The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quit rate		6 months
Primary	Reduction Rate (reduction of cigarette consumption by at least 50% compared with baseline)		6 months
Primary	Adherence Rate to NRT		4 weeks
Secondary	Validated quit rate (by measuring exhaled CO and urinary cotinine level)		6 months
Secondary	Quit rate without validation		1 month
Secondary	self-reported use of NRT for at least 4 weeks or 8 weeks, without cotinine validation		1 month / 3 month

External Links

•   HAREC Clinical Trial Registry