Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02796391 - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes Phase 2
Completed NCT03397511 - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City N/A
Not yet recruiting NCT05188287 - A Culturally Tailored Smartphone Application for African American Smokers N/A
Recruiting NCT05264428 - The Effect of Honey on Lessening the Withdrawal Symptoms N/A
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Completed NCT03187730 - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants Phase 4
Completed NCT03474783 - To Explore the Factors Affecting the Effectiveness of Smoking Cessation N/A
Completed NCT04635358 - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center N/A
Terminated NCT03670264 - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation N/A
Not yet recruiting NCT06307496 - VIDeOS for Smoking Cessation N/A
Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02905656 - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit N/A
Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
Completed NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers N/A
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A