Early Phase 1
N=21
Reduced Nicotine Cigarette Purchasing Decisions
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04999644 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Demand Intensity — 6.48; 8.10; 7.81; 6.48 cigarettes
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Full Nicotine Cigarettes (Drug); Reduced Nicotine Cigarettes (Drug); Average Nicotine Expectancy (Behavioral); Very Low Nicotine Expectancy (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Demand Intensity |
6.48; 8.10; 7.81; 6.48 | — |
| PRIMARY Demand Elasticity |
-1.31; -1.45; -1.57; -1.26 | — |
| SECONDARY Minnesota Nicotine Withdrawal Scale |
5.67; 5.14; 4.33; 6.24 | — |
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.
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04999644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.