Smoking Reduction and Cessation Interventions for Chinese

Smoking Cessation Clinical Trial

Official title:

A Stage-Based Scheduled Smoking Intervention for Chinese

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714532
• Other study ID #: 14RT-0160H
• Secondary ID: TRDRP grant: 14R
• Status: Completed
• Phase: N/A
• First received: July 9, 2008
• Last updated: July 9, 2013
• Start date: April 2007
• Est. completion date: June 2009

Study information

• Verified date: July 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study aims at developing and testing a stage-based scheduled smoking intervention that targets to encourage smokers to reduce smoking and to facilitate smoking abstinence. We hypothesize that smokers who receive the staged-based scheduled smoking intervention will be more likely to report smoking abstinence, quit attempts, and smoking reduction at 12 months.

Description:

The objective of the study is to document and systematically investigate the use of smoking reduction and cessation strategies targeting Chinese American smokers at various level of readiness to quit smoking.

Using a randomized controlled study design, the experimental intervention will be compared to a control group that will receive the expert system intervention only at 3-, 6- and 12-month follow-up. The primary aim is to test the following hypotheses:

1. Participants receiving the experimental intervention will be more likely to achieve at least a 50% reduction from baseline at 3-month (end of treatment), 6- and 12-month follow-up than participants in the control condition.

2. Participants receiving the experimental intervention will be more likely to report a 24- hour quit attempt at 3-, 6- and 12-month follow-up.

3. Participants receiving the experimental intervention will be report a longer length of abstinence in their quit attempts at 3-, 6- and 12-month follow-up.

4. The experimental condition will yield a higher rate of smoking abstinence at 3-, 6- and 12-month follow-up.

The secondary aim is to examine the feasibility of the proposed intervention which will be assessed by recruitment efficiency, refusal rates, adherence, usage, safety data, and perceived helpfulness of the intervention components. In addition, analyses will be pursued to explore both short- and long-term maintenance of smoking reduction achieved, the association between smoking reduction and changes in self-efficacy of resisting from smoking, stage movements (changes in readiness for quitting), and the use of coping strategies for smoking at follow-ups. The study will provide important empirical data for developing effective smoking cessation strategies that are culturally and linguistically appropriate for the Chinese American population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-identified ethnic Chinese men and women

• 18 years or older

• report smoking cigarettes daily with at least 5 cigarettes per day in the last 7 days

• reside in California

• be able to read written English or Chinese

Exclusion Criteria:

• Currently engaging in assisted smoking cessation efforts

• Have health conditions that have contraindications of using nicotine replacement treatment (NRT) such as pregnancy, within 6 months post MI, severe or unstable angina

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Expert System Only
Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months
• Enhanced Expert System
The intervention consists of 3 components: Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months scheduled smoking intervention, which includes a tailored-made 3-week smoking reduction schedule and a stage-matched tip guide to explain why and how to use the smoking reduction intervention telephone check-in calls to provide brief counseling and technical support to motivate participants to use the intervention materials a 2-week supply of nicotine gum or lozenge per participants' choice to use during smoking reduction

Locations

Country	Name	City	State
United States	UCSF Langley Porter	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-report 7-day smoking abstinence		12 months	No
Secondary	self-report a 24-hour quit attempt		12 months	No
Secondary	50% or more reduction in smoking from baseline		12 months	No