Tobacco Use DisorderEarly Phase 1NCT04999644

Reduced Nicotine Cigarette Purchasing Decisions

A Early Phase 1 study testing Full Nicotine Cigarettes, Reduced Nicotine Cigarettes and Average Nicotine Expectancy in people with Tobacco Use Disorder, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this project is to experimentally evaluate how expectations about reduced-nicotine cigarettes as well as actual nicotine content interact to determine behavioral and subjective response for these novel products. Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Tobacco Use Disorder
What is being tested?: Full Nicotine Cigarettes, Reduced Nicotine Cigarettes and Average Nicotine Expectancy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 23 Feb 2022to 29 Mar 2023
Phase: Early Phase 1
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 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

21 years or older
Smoke five or more cigarettes per day for the past six months
Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 8 ppm and a urinary cotinine level of more than 100 ng per milliliter at screening

Who cannot join

Intention to quit smoking in the next 30 days
Weekly use of nicotine-containing products other than machine-manufactured combustible cigarettes
Serious medical or psychiatric disorder precluding participation by study physician guidance
Positive urine screening for illicit drugs other than cannabis or current substance use disorder
Women who are pregnant, plan to become pregnant, or are breast-feeding
Medical contraindications to receiving tobacco products

Trial locations and contacts

1 site in 1 country.

United States1 site

Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224

Other trials in United States

About this study

Conditions: Tobacco Use Disorder
Being tested: Full Nicotine Cigarettes, Reduced Nicotine Cigarettes, Average Nicotine Expectancy, Very Low Nicotine Expectancy
Medical subject headings: Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Full Nicotine CigarettesDrug
A full nicotine tobacco cigarette that will be smoked by participants
Reduced Nicotine CigarettesDrug
A reduced nicotine tobacco cigarette that will be smoked by participants
Average Nicotine ExpectancyBehavioural
Participant instructed the cigarette is "the same level of nicotine as your usual brand."
Very Low Nicotine ExpectancyBehavioural
Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand."

Study groups in NCT04999644
Study group	Role	What they receive
Full Nicotine Expectancy, Reduced Nicotine Dose	Experimental	Receive reduced nicotine cigarette expecting full Receives: Drug: Reduced Nicotine Cigarettes; Behavioral: Average Nicotine Expectancy
Full Nicotine Expectancy, Full Nicotine Dose	Experimental	Receive full nicotine cigarette expecting full Receives: Drug: Full Nicotine Cigarettes; Behavioral: Average Nicotine Expectancy
Reduced Nicotine Expectancy, Full Nicotine Dose	Experimental	Receive full nicotine cigarette expecting reduced Receives: Drug: Full Nicotine Cigarettes; Behavioral: Very Low Nicotine Expectancy
Reduced Nicotine Expectancy, Reduced Nicotine Dose	Experimental	Receive reduced nicotine cigarette expecting reduced Receives: Drug: Reduced Nicotine Cigarettes; Behavioral: Very Low Nicotine Expectancy

What is being measured

The primary outcome is the main question the study is designed to answer.

Demand Intensity
Consumption of cigarettes at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more cigarette consumption at unconstrained price (a worse outcome).
Measured: Four times over approximately two weeks
Demand Elasticity
Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome). Values are log-transformed. Data are presented for all subjects with non-zero data (zero data cannot be analyzed with a demand function so elasticity cannot be generated)
Measured: Four times over approximately two weeks

Secondary outcomes (1)

Minnesota Nicotine Withdrawal Scale
A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome).
Measured: Post-cigarette administration four times over approximately two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 202229 Mar 2023

First posted11 Aug 2021
Study start23 Feb 2022
Primary completion29 Mar 2023
Study completion29 Mar 2023

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 Use DisorderStudies 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: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04999644
Sponsor's protocol ID: IRB00288837
Other IDs: R03DA054098-01
Status last verified: Feb 2024
First submitted: 15 Jul 2021
Last updated: 9 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
Tobacco Use, Tobacco Use Cessation
Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
Recruiting
Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily
Tobacco Use Disorder
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Not yet recruiting
Cardiovascular Impacts of E-cigarettes Among Older Adults
Hypertension, Tobacco Cigarette Smoking

All Tobacco Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reduced Nicotine Cigarette Purchasing Decisions
ClinicalTrials.gov ID: NCT04999644
Acronym / sponsor ID: IRB00288837
Conditions: Tobacco Use Disorder
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 23 Feb 2022 (actual)
Primary completion: 29 Mar 2023 (actual)
Study completion: 29 Mar 2023 (actual)
First posted: 11 Aug 2021 (actual)
Results: Posted 9 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Full Nicotine Expectancy, Reduced Nicotine Dose	Experimental	Drug: Reduced Nicotine Cigarettes, Behavioral: Average Nicotine ExpectancyReceive reduced nicotine cigarette expecting full
Full Nicotine Expectancy, Full Nicotine Dose	Experimental	Drug: Full Nicotine Cigarettes, Behavioral: Average Nicotine ExpectancyReceive full nicotine cigarette expecting full
Reduced Nicotine Expectancy, Full Nicotine Dose	Experimental	Drug: Full Nicotine Cigarettes, Behavioral: Very Low Nicotine ExpectancyReceive full nicotine cigarette expecting reduced
Reduced Nicotine Expectancy, Reduced Nicotine Dose	Experimental	Drug: Reduced Nicotine Cigarettes, Behavioral: Very Low Nicotine ExpectancyReceive reduced nicotine cigarette expecting reduced

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

21 years or older
Smoke five or more cigarettes per day for the past six months
Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 8 ppm and a urinary cotinine level of more than 100 ng per milliliter at screening

Key exclusion criteria (6 listed)

Intention to quit smoking in the next 30 days
Weekly use of nicotine-containing products other than machine-manufactured combustible cigarettes
Serious medical or psychiatric disorder precluding participation by study physician guidance
Positive urine screening for illicit drugs other than cannabis or current substance use disorder
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
Full Nicotine CigarettesA full nicotine tobacco cigarette that will be smoked by participants	Drug	Full Nicotine Expectancy, Full Nicotine Dose, Reduced Nicotine Expectancy, Full Nicotine Dose
Reduced Nicotine CigarettesA reduced nicotine tobacco cigarette that will be smoked by participants	Drug	Full Nicotine Expectancy, Reduced Nicotine Dose, Reduced Nicotine Expectancy, Reduced Nicotine Dose
Average Nicotine ExpectancyParticipant instructed the cigarette is "the same level of nicotine as your usual brand."	Behavioural	Full Nicotine Expectancy, Full Nicotine Dose, Full Nicotine Expectancy, Reduced Nicotine Dose
Very Low Nicotine ExpectancyParticipant instructed the cigarette is "a very low level of nicotine compared to your usual brand."	Behavioural	Reduced Nicotine Expectancy, Full Nicotine Dose, Reduced Nicotine Expectancy, Reduced Nicotine Dose

Primary outcome

Demand Intensity
Time frame: Four times over approximately two weeks
Consumption of cigarettes at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more cigarette consumption at unconstrained price (a worse outcome).
Demand Elasticity
Time frame: Four times over approximately two weeks
Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome). Values are log-transformed. Data are presented for all subjects with non-zero data (zero data cannot be analyzed with a demand function so elasticity cannot be generated)

1 secondary outcome

Minnesota Nicotine Withdrawal Scale
Time frame: Post-cigarette administration four times over approximately two weeks

Results and safety

Results posted to the registry on 9 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Included in Analysis	21	21

Primary outcome: Demand Intensity

Time frame: Four times over approximately two weeks. Mean (Standard Error). Unit: cigarettes

Measure	Subjects Included in Analysis n = 21
Condition A: Told Full, Received Reduced	6.48 (4.55)
Condition B: Told Full, Received Full	8.10 (6.61)
Condition C: Told Reduced, Received Full	7.81 (5.63)
Condition D: Told Reduced, Received Reduced	6.48 (4.91)

Primary outcome: Demand Elasticity

Time frame: Four times over approximately two weeks. Mean (Standard Deviation). Unit: log(cigarettes/dollar)

Measure	Subjects Included in Analysis n = 21
Condition A: Told Full, Received Reduced	-1.31 (1.08)
Condition B: Told Full, Received Full	-1.45 (0.50)
Condition C: Told Reduced, Received Full	-1.57 (0.60)
Condition D: Told Reduced, Received Reduced	-1.26 (1.17)

Population analysed: Data are presented for all subjects with non-zero data

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Approximately two weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Included in Analysis	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Tobacco Use Disorder

Recruiting
Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
Tobacco Use, Tobacco Use Cessation
Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
Recruiting
Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily
Tobacco Use Disorder
Recruiting
Use of Nicotine Pouches Among Daily Smokers
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Not yet recruiting
Cardiovascular Impacts of E-cigarettes Among Older Adults
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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 Johnson principal investigator

Johns Hopkins School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 9 Feb 2024. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2024). 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 (time frame: Four times over approximately two weeks). The study lists 2 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 NCT04999644.

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 9 Feb 2024.