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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02421224
Other study ID # UCaliforniaBerkeley
Secondary ID 5R01DA035384
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date August 2017

Study information

Verified date December 2020
Source University of California, Berkeley
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators will conduct a cluster randomized controlled trial of several behavioral interventions for smoking cessation among a sample of employees at large workplaces in the Bangkok metropolitan area. The study aims to test the impacts of different incentive structures for smoking cessation on take-up, effectiveness, and cost-effectiveness. The interventions are designed to elucidate certain principles from the field of behavioral economics.


Recruitment information / eligibility

Status Completed
Enrollment 4190
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Current full-time employee of a participating company - Smoker of 100+ cigarettes during lifetime - Smoker of 10+ cigarettes per week - Individual is aged 18+ years old - Smoker wants to quit within the next 6 months Exclusion Criteria: - Expects to leave company within the next 12 months - Is currently pregnant - Are unable to provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Usual Care
Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
Deposits
Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
Small Individual Bonus
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
Large Individual Bonus
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group.
Teammate
Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.
Team Bonus
If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group.

Locations

Country Name City State
Thailand Mahidol University Bangkok

Sponsors (4)

Lead Sponsor Collaborator
University of California, Berkeley Mahidol University, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

White JS, Lowenstein C, Srivirojana N, Jampaklay A, Dow WH. Incentive programmes for smoking cessation: cluster randomized trial in workplaces in Thailand. BMJ. 2020 Oct 14;371:m3797. doi: 10.1136/bmj.m3797. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Participants With Smoking Abstinence at 12 Months 7-day point prevalence of abstinence measured 12 months after enrollment using self-reported abstinence and urine cotinine test results 12 months after enrollment
Secondary Proportion of Participants With Smoking Abstinence at 3 Months 7-day point prevalence of abstinence measured 3 months after enrollment based on self-reported abstinence and urine cotinine test results 3 months after enrollment
Secondary Program Acceptance Proportion of eligible smokers who consent to participate in the main intervention At 0 months (at enrollment)
Secondary Proportion of Participants With Smoking Abstinence at 6 Months 7-day point prevalence of abstinence measured 6 months after enrollment based on self-reported abstinence and urine cotinine test results 6 months after enrollment
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