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NCT04999644

Reduced Nicotine Cigarette Purchasing Decisions

Completed EARLY_PHASE1 Results posted Last updated 9 February 2024
What this trial tests

EARLY_PHASE1 trial testing Full Nicotine Cigarettes in Tobacco Use Disorder in 21 participants. Completed in 29 March 2023.

Timeline
23 February 2022
Primary endpoint
29 March 2023
29 March 2023

Quick facts

Lead sponsorJohns Hopkins University
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposebasic science
Enrollment21
Start date23 February 2022
Primary completion29 March 2023
Estimated completion29 March 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

21 and older, any sex, with Tobacco Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Demand Intensity Primary · 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).

Condition A: Told Full, Received Reduced
GroupValue95% CI
Subjects Included in Analysis6.48± 4.55
Condition B: Told Full, Received Full
GroupValue95% CI
Subjects Included in Analysis8.10± 6.61
Condition C: Told Reduced, Received Full
GroupValue95% CI
Subjects Included in Analysis7.81± 5.63
Condition D: Told Reduced, Received Reduced
GroupValue95% CI
Subjects Included in Analysis6.48± 4.91
Demand Elasticity Primary · 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)

Condition A: Told Full, Received Reduced
GroupValue95% CI
Subjects Included in Analysis-1.31± 1.08
Condition B: Told Full, Received Full
GroupValue95% CI
Subjects Included in Analysis-1.45± 0.50
Condition C: Told Reduced, Received Full
GroupValue95% CI
Subjects Included in Analysis-1.57± 0.60
Condition D: Told Reduced, Received Reduced
GroupValue95% CI
Subjects Included in Analysis-1.26± 1.17
Minnesota Nicotine Withdrawal Scale Secondary · Post-cigarette administration four times over approximately two weeks

A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome).

Condition A: Told Full, Received Reduced
GroupValue95% CI
Subjects Included in Analysis5.67± 6.95
Condition B: Told Full, Received Full
GroupValue95% CI
Subjects Included in Analysis5.14± 6.54
Condition C: Told Reduced, Received Full
GroupValue95% CI
Subjects Included in Analysis4.33± 4.95
Condition D: Told Reduced, Received Reduced
GroupValue95% CI
Subjects Included in Analysis6.24± 6.47

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Tobacco Use Disorder

Currently open trials in the same condition.

Other Johns Hopkins University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04999644.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing