Smoking CessationNCT04982952
Contingency Management for Smoking Cessation
A study testing Contingency Management - Increasing and Fixed payments in people with Smoking Cessation and Smoking, Tobacco, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The prevalence of smoking in the homeless population (70%) is over 4 times that of the general population (15%). Homeless adults have not experienced similar declines in tobacco use as the general population has over the past three decades. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Tobacco, Smoking Reduction
- What is being tested?
- Contingency Management - Increasing and Fixed payments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Are 18 years or older
- Engaged in care at the Tom Waddell Urban Health Center (TWUHC)
- Meet criteria for homelessness as defined by the Homeless Emergency Assistance and Rapid Transition to Housing Act
- Are current smokers (smoked at least 100 cigarettes in lifetime, smoked daily in the past 7 days and at least 5 cigarettes per day, verified by expired Carbon Monoxide (CO) >= 8 parts per million (ppm))
- Have an intention to quit smoking within the next six months
- Are attending on-site smoking cessation counseling provided by the behavioral counselors
- Are English proficient
- Are able to provide informed consent. Patients who are interested in participating but not enrolled in counseling services will be encouraged to engage in counseling sessions at the time of enrollment.
Who cannot join
- 1. Are unable to take nicotine replacement therapy (e.g., pregnancy or myocardial infarction (MI) within the past 2 weeks)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Richard H. Fine's People's Clinic
San Francisco, California, 94110
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Randomized Trial of a Contingency Management Smoking Cessation Intervention for Homeless Adults
The prevalence of smoking in the homeless population (70%) is over 4 times that of the general population (15%). Homeless adults have not experienced similar declines in tobacco use as the general population has over the past three decades. Homeless adults are interested in smoking cessation and make quit attempts, but are less successful in quitting smoking than the general population. Trials of group behavioral counseling and pharmacotherapy for smoking cessation have not led to substantial long-term abstinence (i.e., abstinence for 6 months or more), suggesting that these interventions alone are insufficient to improve quit rates among homeless adults. Many homeless adults seek health care in safety net clinics; these clinics could bring cessation interventions to scale. Contingency management is a powerful behavior change intervention that reinforces positive health behaviors through the provision of modest incentives (e.g., cash). In this pilot randomized controlled trial, the investigator will test the feasibility and acceptability of a contingency management intervention that provides incentives for smoking cessation for people experiencing homelessness.
Read the detailed description
In this pilot randomized controlled trial (RCT), the investigator will (1) adapt a known-efficacious extended CM cessation intervention to a novel population and setting, with the ultimate goal of increasing long-term abstinence among homeless adults seeking care in safety net health clinics, (2) develop a corresponding RCT protocol, and (3) conduct a pilot RCT to assess the feasibility and acceptability of the RCT. If the pilot RCT is feasible and acceptable, the investigator will test the adapted intervention in a subsequently-funded, full-scale RCT.
Primary Objectives:
Assess feasibility and acceptability of a CM intervention through:
- Measuring biochemically-verified point prevalence abstinence at 6 months follow-up.
- Measuring participant adherence to the protocol.
- Gathering information on the number of visits attended.
- Assessing the retention protocol.
Secondary Objectives
Assess feasibility and acceptability of a CM intervention through:
- Biochemically-verified 7-day point months follow-up at 3 months.
- Prolonged abstinence at 3 months and 6 months follow-up.
- Point-prevalent abstinence at 12 months
- Conditions
- Smoking Cessation, Smoking, Tobacco, Smoking Reduction
- Being tested
- Contingency Management - Increasing, Fixed payments
- Keywords
- Contingency Management
- Medical subject headings
- Smoking Cessation, Tobacco Smoking, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency Management - IncreasingBehavioural
Increasing incentive payment for abstinent participant
Fixed paymentsBehavioural
Fixed payments for attending study visits
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management (CM) | Experimental | In addition to receiving usual cessation care at the Tom Waddell Urban Health Center (TWUHC), CM intervention participants with CO-verified abstinence will obtain a CM incentive payment, via gift cards and/or cash redeemable in national retail chains. Receives: Behavioral: Contingency Management - Increasing |
| Control Group | Other | Participants who choose to attend smoking cessation in the usual care setting at TWUHC will receive a basic $5 payment for attending each study visit. Receives: Behavioral: Fixed payments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieve point prevalence abstinence
The proportion of participants who achieve biochemically-verified 7-day point prevalence abstinence defined as participants (1) reporting not smoking a single cigarette in the past seven days, not even a puff; (2) having carbon monoxide (CO) levels <=5 parts per million (ppm), and (3) urinary anatabine/anabasine assay levels < 2 nanograms per milliliter (ng/ml).
Measured: 6 months
Median number of carbon monoxide (CO) negative samples
The total number of negative CO specimen samples collected throughout the first 6 months of the program will be reported with 24 maximum possible number of samples per person.
Measured: 6 months
Median total number of counseling sessions attended
The number of counseling sessions attended per person will will recorded with a maximum of 5 sessions total.
Measured: 6 months
Proportion of the sample retained as a result of retention procedures over time
The proportion of participants who choose to attend cessation sessions visits at 2 weeks, 1 month, 3 months, 6 months, and 12 months. A participant will be considered lost to follow-up and censored on their last visits if the participants have failed to return for a scheduled visit and the study staff are unable to contact the participant after at least 3 attempts.
Measured: Up to 12 months
Secondary outcomes (3)
Proportion of participants who achieve point prevalence abstinence
The proportion of participants who achieve biochemically-verified 7-day point prevalence abstinence defined as participants (1) reporting not smoking a single cigarette in the past seven days, not even a puff; (2) having carbon monoxide (CO) levels <=5 parts per million (ppm)
Measured: 3 months
Proportion of participants who achieve point prevalence abstinence
The proportion of participants who achieve biochemically-verified 7-day point prevalence abstinence defined as participants (1) reporting not smoking a single cigarette in the past seven days, not even a puff; (2) having carbon monoxide (CO) levels <=5 parts per million (ppm)
Measured: 12 months
Proportion of participants who achieve prolonged abstinence over time
Prolonged abstinence is defined as participants (1) not smoking a single cigarette since the last visit; (2) having CO levels <=5 ppm
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start9 Nov 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization into one of 2 groups will be stratified by recruiter and a binary nicotine dependency code
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Maya Vijayaraghavan, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982952
- Sponsor's protocol ID
- 21632
- Other IDs
- NCI-2021-08359
- Status last verified
- Dec 2024
- First submitted
- 23 Jul 2021
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gu D, Chakravarty D, Cuby J, Hall S, Stitzer M, Kushel M, Xia F, Vijayaraghavan M. Contingency Management for Smoking Cessation Among Adults Experiencing Homelessness: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2627917. doi: 10.1001/jamanetworkopen.2026.27917.
PubMed 42579279Molina MF, Hall SM, Stitzer M, Kushel M, Chakravarty D, Vijayaraghavan M. Contingency management to promote smoking cessation in people experiencing homelessness: Leveraging the electronic health record in a pilot, pragmatic randomized controlled trial. PLoS One. 2022 Dec 16;17(12):e0278870. doi: 10.1371/journal.pone.0278870. eCollection 2022.
PubMed 36525405
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Contingency Management Smoking Cessation Intervention for Homeless Adults
- ClinicalTrials.gov ID
- NCT04982952
- Acronym / sponsor ID
- 21632
- Conditions
- Smoking Cessation, Smoking, Tobacco, Smoking Reduction
- Keywords
- Contingency Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of smoking in the homeless population (70%) is over 4 times that of the general population (15%). Homeless adults have not experienced similar declines in tobacco use as the general population has over the past three decades. Homeless adults are interested in smoking cessation and make quit attempts, but are less successful in quitting smoking than the general population. Trials of group behavioral counseling and pharmacotherapy for smoking cessation have not led to substantial long-term abstinence (i.e., abstinence for 6 months or more), suggesting that these interventions alone are insufficient to improve quit rates among homeless adults. Many homeless adults seek health care in safety net clinics; these clinics could bring cessation interventions to scale. Contingency management is a powerful behavior change intervention that reinforces positive health behaviors through the provision of modest incentives (e.g., cash). In this pilot randomized controlled trial, the investigator will test the feasibility and acceptability of a contingency management intervention that provides incentives for smoking cessation for people experiencing homelessness.
Detailed description
In this pilot randomized controlled trial (RCT), the investigator will (1) adapt a known-efficacious extended CM cessation intervention to a novel population and setting, with the ultimate goal of increasing long-term abstinence among homeless adults seeking care in safety net health clinics, (2) develop a corresponding RCT protocol, and (3) conduct a pilot RCT to assess the feasibility and acceptability of the RCT. If the pilot RCT is feasible and acceptable, the investigator will test the adapted intervention in a subsequently-funded, full-scale RCT.
Primary Objectives:
Assess feasibility and acceptability of a CM intervention through:
- Measuring biochemically-verified point prevalence abstinence at 6 months follow-up.
- Measuring participant adherence to the protocol.
- Gathering information on the number of visits attended.
- Assessing the retention protocol.
Secondary Objectives
Assess feasibility and acceptability of a CM intervention through:
- Biochemically-verified 7-day point months follow-up at 3 months.
- Prolonged abstinence at 3 months and 6 months follow-up.
- Point-prevalent abstinence at 12 months
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization into one of 2 groups will be stratified by recruiter and a binary nicotine dependency code
| Arm | Type | Receives |
|---|---|---|
| Contingency Management (CM) | Experimental | Behavioral: Contingency Management - IncreasingIn addition to receiving usual cessation care at the Tom Waddell Urban Health Center (TWUHC), CM intervention participants with CO-verified abstinence will obtain a CM incentive payment, via gift cards and/or cash redeemable in national retail chains. |
| Control Group | Other | Behavioral: Fixed paymentsParticipants who choose to attend smoking cessation in the usual care setting at TWUHC will receive a basic $5 payment for attending each study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are 18 years or older
- Engaged in care at the Tom Waddell Urban Health Center (TWUHC)
- Meet criteria for homelessness as defined by the Homeless Emergency Assistance and Rapid Transition to Housing Act
- Are current smokers (smoked at least 100 cigarettes in lifetime, smoked daily in the past 7 days and at least 5 cigarettes per day, verified by expired Carbon Monoxide (CO) >= 8 parts per million (ppm))
- Have an intention to quit smoking within the next six months
Key exclusion criteria (1 listed)
- 1. Are unable to take nicotine replacement therapy (e.g., pregnancy or myocardial infarction (MI) within the past 2 weeks)
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 |
|---|---|---|
| Contingency Management - IncreasingIncreasing incentive payment for abstinent participant | Behavioural | Contingency Management (CM) |
| Fixed paymentsFixed payments for attending study visits | Behavioural | Control Group |
Primary outcome
Proportion of participants who achieve point prevalence abstinence
Time frame: 6 months
The proportion of participants who achieve biochemically-verified 7-day point prevalence abstinence defined as participants (1) reporting not smoking a single cigarette in the past seven days, not even a puff; (2) having carbon monoxide (CO) levels <=5 parts per million (ppm), and (3) urinary anatabine/anabasine assay levels < 2 nanograms per milliliter (ng/ml).
Median number of carbon monoxide (CO) negative samples
Time frame: 6 months
The total number of negative CO specimen samples collected throughout the first 6 months of the program will be reported with 24 maximum possible number of samples per person.
Median total number of counseling sessions attended
Time frame: 6 months
The number of counseling sessions attended per person will will recorded with a maximum of 5 sessions total.
Proportion of the sample retained as a result of retention procedures over time
Time frame: Up to 12 months
The proportion of participants who choose to attend cessation sessions visits at 2 weeks, 1 month, 3 months, 6 months, and 12 months. A participant will be considered lost to follow-up and censored on their last visits if the participants have failed to return for a scheduled visit and the study staff are unable to contact the participant after at least 3 attempts.
3 secondary outcomes
Proportion of participants who achieve point prevalence abstinence
Time frame: 3 months
Proportion of participants who achieve point prevalence abstinence
Time frame: 12 months
Proportion of participants who achieve prolonged abstinence over time
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 42579279Gu D, Chakravarty D, Cuby J, Hall S, Stitzer M, Kushel M, Xia F, Vijayaraghavan M. Contingency Management for Smoking Cessation Among Adults Experiencing Homelessness: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2627917. doi: 10.1001/jamanetworkopen.2026.27917.
- Derived from this study: PubMed 36525405Molina MF, Hall SM, Stitzer M, Kushel M, Chakravarty D, Vijayaraghavan M. Contingency management to promote smoking cessation in people experiencing homelessness: Leveraging the electronic health record in a pilot, pragmatic randomized controlled trial. PLoS One. 2022 Dec 16;17(12):e0278870. doi: 10.1371/journal.pone.0278870. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Maya Vijayaraghavan, MD, MAS principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management - Increasing and Fixed payments in people with Smoking Cessation and Smoking, Tobacco, run by University of California, San Francisco at 2 sites in United States.
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 8 inclusion and 1 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 who achieve point prevalence abstinence (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT04982952, which also lists 2 linked publications.
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 5 Dec 2024.