Tobacco SmokingNCT04595279
Cigarette Smoking Decision Study
A study testing Smoking sessions in people with Tobacco Smoking, run by Johns Hopkins University at 1 site in United States.
Trial summary
The Family Smoking Prevention and Tobacco Control Act granted the FDA the authority to regulate and restrict tobacco advertising tactics that inaccurately convey reduced product risk, yet there is a dearth of up-to-date regulatory science to inform such regulations. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Smoking sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 22 Mar 2024
- 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 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 29 years of age
- Smoke at least five cigarettes per day
- Have an expired carbon monoxide level of more than 8 ppm or a urinary cotinine level of more than 100 ng per milliliter
Who cannot join
- The intention to quit smoking in the next 30 days
- Report "roll your own" cigarettes as an exclusive form of smoking
- A serious medical or psychiatric disorder or unstable condition
- Any positive toxicological screening for illicit drugs other than cannabis will be excluded
- Women who are pregnant, plan to become pregnant or are breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
The Family Smoking Prevention and Tobacco Control Act granted the FDA the authority to regulate and restrict tobacco advertising tactics that inaccurately convey reduced product risk, yet there is a dearth of up-to-date regulatory science to inform such regulations. Although the FDA has restricted use of descriptors such as "natural" and "additive-free," research shows that the tobacco industry quickly pivoted to increase use of alternative, unregulated tactics. Greenwashing is one increasingly common tobacco marketing strategy in which products are portrayed as eco-friendly and/or natural. The investigators' preliminary research indicates that greenwashing tactics may inaccurately convey modified product risk to consumers. The overarching objective of this project is to test the effect of greenwashing methods used by cigarette companies to market products on actual smoking behavior in a controlled laboratory study. The investigators' proposed research focuses on young adults (age 18-29), because this is a key age for smoking initiation and escalation, and research has found that young adults may be more susceptible than older adults to greenwashing in cigarette ads. This study will test the effect of greenwashing on behavioral economic demand and smoking topography in a laboratory-controlled cigarette self-administration study. These data will clearly connect tobacco advertising features to product risk perceptions and actual smoking behavior. This work will provide FDA with an integrated set of evidence that identifies misleading greenwashing tactics that inaccurately convey modified product risk which can be used to inform regulatory action regarding restrictions of this type of advertising.
- Conditions
- Tobacco Smoking
- Being tested
- Smoking sessions
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking sessionsBehavioural
Participants undergo topography and behavioral economic sessions where they can make choices to earn cigarette puffs by pulling plungers on experimental equipment
| Study group | Role | What they receive |
|---|---|---|
| Smoking sessions | Experimental | This is the single arm that will go through cigarette smoking sessions Receives: Behavioral: Smoking sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demand Intensity as Assessed by a Behavioral Economic Demand Curve
Number of cigarette puff bouts smoked at no cost as measured by a demand curve
Measured: Through study completion, an average of 2 weeks
Demand Elasticity as Assessed by a Behavioral Economic Demand Curve
Sensitivity of cigarette consumption to changes in cost for cigarettes
Measured: Through study completion, an average of 2 weeks
Cross-price Elasticity Coefficients as Assessed by a Behavioral Economic Demand Curve
Sensitivity of cigarette consumption to changes in cost for alternative products as a linear slope.
Measured: Through study completion, an average of 2 weeks
Change in Total Puff Volume as Measured by a Smoking Topography Machine
Total cigarette puff volume in milliliters (mls)
Measured: Days 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start18 Aug 2021
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
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.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Matthew W Johnson, Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595279
- Sponsor's protocol ID
- IRB00264306
- Other IDs
- R01DA049814
- Status last verified
- May 2025
- First submitted
- 14 Oct 2020
- Last updated
- 15 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cigarette Smoking Decision Study
- ClinicalTrials.gov ID
- NCT04595279
- Acronym / sponsor ID
- IRB00264306
- Conditions
- Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Posted 15 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Family Smoking Prevention and Tobacco Control Act granted the FDA the authority to regulate and restrict tobacco advertising tactics that inaccurately convey reduced product risk, yet there is a dearth of up-to-date regulatory science to inform such regulations. Although the FDA has restricted use of descriptors such as "natural" and "additive-free," research shows that the tobacco industry quickly pivoted to increase use of alternative, unregulated tactics. Greenwashing is one increasingly common tobacco marketing strategy in which products are portrayed as eco-friendly and/or natural. The investigators' preliminary research indicates that greenwashing tactics may inaccurately convey modified product risk to consumers. The overarching objective of this project is to test the effect of greenwashing methods used by cigarette companies to market products on actual smoking behavior in a controlled laboratory study. The investigators' proposed research focuses on young adults (age 18-29), because this is a key age for smoking initiation and escalation, and research has found that young adults may be more susceptible than older adults to greenwashing in cigarette ads. This study will test the effect of greenwashing on behavioral economic demand and smoking topography in a laboratory-controlled cigarette self-administration study. These data will clearly connect tobacco advertising features to product risk perceptions and actual smoking behavior. This work will provide FDA with an integrated set of evidence that identifies misleading greenwashing tactics that inaccurately convey modified product risk which can be used to inform regulatory action regarding restrictions of this type of advertising.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking sessions | Experimental | Behavioral: Smoking sessionsThis is the single arm that will go through cigarette smoking sessions |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 - 29 years of age
- Smoke at least five cigarettes per day
- Have an expired carbon monoxide level of more than 8 ppm or a urinary cotinine level of more than 100 ng per milliliter
Key exclusion criteria (5 listed)
- The intention to quit smoking in the next 30 days
- Report "roll your own" cigarettes as an exclusive form of smoking
- A serious medical or psychiatric disorder or unstable condition
- Any positive toxicological screening for illicit drugs other than cannabis will be excluded
- Women who are pregnant, plan to become pregnant or are breast-feeding
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 |
|---|---|---|
| Smoking sessionsParticipants undergo topography and behavioral economic sessions where they can make choices to earn cigarette puffs by pulling plungers on experimental equipment | Behavioural | Smoking sessions |
Primary outcome
Demand Intensity as Assessed by a Behavioral Economic Demand Curve
Time frame: Through study completion, an average of 2 weeks
Number of cigarette puff bouts smoked at no cost as measured by a demand curve
Demand Elasticity as Assessed by a Behavioral Economic Demand Curve
Time frame: Through study completion, an average of 2 weeks
Sensitivity of cigarette consumption to changes in cost for cigarettes
Cross-price Elasticity Coefficients as Assessed by a Behavioral Economic Demand Curve
Time frame: Through study completion, an average of 2 weeks
Sensitivity of cigarette consumption to changes in cost for alternative products as a linear slope.
Change in Total Puff Volume as Measured by a Smoking Topography Machine
Time frame: Days 2 and 3
Total cigarette puff volume in milliliters (mls)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Matthew W Johnson, Ph.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking sessions in people with Tobacco Smoking, run by Johns Hopkins University at 1 site 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 3 inclusion and 5 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 15 Jun 2025. 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 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?
Yes. Results are posted in the registry (first posted 15 Jun 2025). 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?
Demand Intensity as Assessed by a Behavioral Economic Demand Curve (time frame: Through study completion, an average of 2 weeks). 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?
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 15 Jun 2025.