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Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns
NA trial testing Low Power in Smoking in 93 participants. Completed in 9 November 2023.
| Lead sponsor | Medical University of South Carolina |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 93 |
| Start date | 1 April 2019 |
| Primary completion | 17 October 2023 |
| Estimated completion | 9 November 2023 |
| Sites | 1 location across United States |
Medical University of South Carolina
21 and older, any sex, with Smoking or Tobacco Use. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participants complete weekly surveys reporting the number of cigarettes smoked each day on a continuous scale
| Group | Value | 95% CI |
|---|---|---|
| Low Concentration / Low Power | 13.1 | ± 9.3 |
| Low Concentration / High Power | 12.6 | ± 6.0 |
| High Concentration / Low Power | 12.2 | ± 8.8 |
| High Concentration / High Power | 13.3 | ± 9.3 |
Participants complete weekly surveys reporting the number of e-cigarette puffing episodes each day on a continuous scale
| Group | Value | 95% CI |
|---|---|---|
| Low Concentration / Low Power | 4.8 | ± 5.4 |
| Low Concentration / High Power | 6.5 | ± 10.7 |
| High Concentration / Low Power | 5.4 | ± 4.5 |
| High Concentration / High Power | 3.0 | ± 4.0 |
Participants complete lab-based choice task at Week 3 visit in which they choose between smoking conventional cigarette and e-cigarette over 10 trials. Outcome is number of times each participant chooses to smoke conventional cigarette.
| Group | Value | 95% CI |
|---|---|---|
| Low Concentration / Low Power | 1.7 | ± 0.42 |
| Low Concentration / High Power | 2.4 | ± 0.38 |
| High Concentration / Low Power | 1.8 | ± 0.44 |
| High Concentration / High Power | 2.4 | ± 0.43 |
Time frame: Two months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Low Concentration / Low Po… | Low Concentration / High P… | High Concentration / Low P… | High Concentration / High … |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Burning in the Throat | Gastrointestinal disorders | — | — | — | — |
| Increased Phlegm | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Throat and Mouth Irritation | Gastrointestinal disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Lung Problems | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT03844672 adverse events section.
The purpose of this project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. During this time period they will complete daily electronic diaries and weekly lab visits. The results from this information will help understand how different types of e-cigarettes are likely to influence cigarette and e-cigarette use.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing