Tobacco Use DisorderSMILENCT02421224
Social and Monetary Incentives for Smoking Cessation at Large Employers
A study testing Deposits, Small Individual Bonus and Large Individual Bonus in people with Tobacco Use Disorder, run by University of California, Berkeley at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Deposits, Small Individual Bonus and Large Individual Bonus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,190 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Expects to leave company within the next 12 months
- Is currently pregnant
- Are unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Usual Care, Deposits, Small Individual Bonus, Large Individual Bonus, Teammate
- Keywords
- Smoking Cessation, Incentives, Health Behavior, Smoking, Work-site
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Health Behavior, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
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.
DepositsBehavioural
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 BonusBehavioural
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 BonusBehavioural
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.
TeammateBehavioural
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 BonusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
| Deposits | Experimental | Same as Usual Care, plus participants will have to deposit a certain amount of their own money as an incentive to quit smoking. Participants will be able to make additional voluntary deposits above the minimum amount. 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. Receives: Behavioral: Usual Care; Behavioral: Deposits |
| Small Individual Bonus | Experimental | Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. Receives: Behavioral: Usual Care; Behavioral: Small Individual Bonus |
| Large Individual Bonus | Experimental | Same as Usual Care, plus 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. Receives: Behavioral: Usual Care; Behavioral: Large Individual Bonus |
| Team Bonus | Experimental | Same as Usual Care, plus each participant will be randomly assigned one teammate to provide social support during the quit attempt. 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. Receives: Behavioral: Usual Care; Behavioral: Teammate; Behavioral: Team Bonus |
| Deposits plus Small Individual Bonus | Experimental | Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Small Individual Bonus group. Receives: Behavioral: Usual Care; Behavioral: Deposits; Behavioral: Small Individual Bonus |
| Deposits plus Large Individual Bonus | Experimental | Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Large Individual Bonus group. Receives: Behavioral: Usual Care; Behavioral: Deposits; Behavioral: Large Individual Bonus |
| Deposits plus Teammate | Experimental | Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will be randomly assigned one other participant to serve as a teammate who provides social support during the quit attempt. Receives: Behavioral: Usual Care; Behavioral: Deposits; Behavioral: Teammate |
| Deposits plus Team Bonus | Experimental | Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group, will be randomly assigned a teammate, and will follow the protocol for the monetary bonus as described for the Team Bonus group. Receives: Behavioral: Usual Care; Behavioral: Deposits; Behavioral: Teammate; Behavioral: Team Bonus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after enrollment
Secondary outcomes (3)
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
Measured: 3 months after enrollment
Program Acceptance
Proportion of eligible smokers who consent to participate in the main intervention
Measured: At 0 months (at enrollment)
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
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Mahidol University
- Responsible party
- Sponsor
- Investigators
- William H. Dow, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421224
- Sponsor's protocol ID
- UCaliforniaBerkeley
- Other IDs
- 5R01DA035384
- Acronym
- SMILE
- Status last verified
- Dec 2020
- First submitted
- 15 Apr 2015
- Last updated
- 30 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 33055176
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Monetary Incentives for Smoking Cessation at Large Employers
- ClinicalTrials.gov ID
- NCT02421224
- Acronym / sponsor ID
- SMILE / UCaliforniaBerkeley
- Conditions
- Tobacco Use Disorder
- Keywords
- Smoking Cessation, Incentives, Health Behavior, Smoking, Work-site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,190 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Mahidol University
- Study start
- Apr 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Posted 18 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareParticipants 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 | Experimental | Behavioral: Usual Care, Behavioral: DepositsSame as Usual Care, plus participants will have to deposit a certain amount of their own money as an incentive to quit smoking. Participants will be able to make additional voluntary deposits above the minimum amount. 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 | Experimental | Behavioral: Usual Care, Behavioral: Small Individual BonusSame as Usual Care, plus 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 | Experimental | Behavioral: Usual Care, Behavioral: Large Individual BonusSame as Usual Care, plus 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. |
| Team Bonus | Experimental | Behavioral: Usual Care, Behavioral: Teammate, Behavioral: Team BonusSame as Usual Care, plus each participant will be randomly assigned one teammate to provide social support during the quit attempt. 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. |
| Deposits plus Small Individual Bonus | Experimental | Behavioral: Usual Care, Behavioral: Deposits, Behavioral: Small Individual BonusSame as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Small Individual Bonus group. |
| Deposits plus Large Individual Bonus | Experimental | Behavioral: Usual Care, Behavioral: Deposits, Behavioral: Large Individual BonusSame as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Large Individual Bonus group. |
| Deposits plus Teammate | Experimental | Behavioral: Usual Care, Behavioral: Deposits, Behavioral: TeammateSame as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will be randomly assigned one other participant to serve as a teammate who provides social support during the quit attempt. |
| Deposits plus Team Bonus | Experimental | Behavioral: Usual Care, Behavioral: Deposits, Behavioral: Teammate, Behavioral: Team BonusSame as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group, will be randomly assigned a teammate, and will follow the protocol for the monetary bonus as described for the Team Bonus group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Expects to leave company within the next 12 months
- Is currently pregnant
- Are unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareParticipants 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. | Behavioural | Deposits, Deposits plus Large Individual Bonus, Deposits plus Small Individual Bonus, Deposits plus Team Bonus, Deposits plus Teammate, Large Individual Bonus, Small Individual Bonus, Team Bonus, Usual Care |
| DepositsParticipants 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. | Behavioural | Deposits, Deposits plus Large Individual Bonus, Deposits plus Small Individual Bonus, Deposits plus Team Bonus, Deposits plus Teammate |
| Small Individual BonusEach participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. | Behavioural | Deposits plus Small Individual Bonus, Small Individual Bonus |
| Large Individual BonusEach 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. | Behavioural | Deposits plus Large Individual Bonus, Large Individual Bonus |
| TeammateEach 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. | Behavioural | Deposits plus Team Bonus, Deposits plus Teammate, Team Bonus |
| Team BonusIf 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. | Behavioural | Deposits plus Team Bonus, Team Bonus |
Primary outcome
Proportion of Participants With Smoking Abstinence at 12 Months
Time frame: 12 months after enrollment
7-day point prevalence of abstinence measured 12 months after enrollment using self-reported abstinence and urine cotinine test results
3 secondary outcomes
Proportion of Participants With Smoking Abstinence at 3 Months
Time frame: 3 months after enrollment
Program Acceptance
Time frame: At 0 months (at enrollment)
Proportion of Participants With Smoking Abstinence at 6 Months
Time frame: 6 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33055176White 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H. Dow, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deposits, Small Individual Bonus and Large Individual Bonus in people with Tobacco Use Disorder, run by University of California, Berkeley at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Smoking Abstinence at 12 Months (time frame: 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02421224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.