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NCT04167384
CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products
NA trial testing Product A in Smoking in 69 participants. Completed in 28 February 2020.
28 February 2020
Quick facts
| Lead sponsor | RAI Services Company |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 69 |
| Start date | 2 December 2019 |
| Primary completion | 28 February 2020 |
| Estimated completion | 28 February 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Product A — full drug profile →
- Product B — full drug profile →
- Product C
- Product D
- Product E
- Product F
- Product G
- Product H
Conditions studied
- Smoking — all drugs for Smoking →
- Tobacco Use — all drugs for Tobacco Use →
- Tobacco Smoking — all drugs for Tobacco Smoking →
Sponsor
RAI Services Company
Who can join
Adults 21 to 60, any sex, with Smoking or Tobacco Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the study investigational products (IPs) by generally healthy subjects.
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:
- PubMed search for NCT04167384
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Product A
Trials testing the same drug.
- NCT07323563 — A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems · NA · not yet recruiting
- NCT07323511 — Abuse Liability for Eight Electronic Nicotine Products · NA · not yet recruiting
- NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
- NCT06777784 — Modern Nicotine Oral Product Abuse Liability · NA · completed
- NCT06356610 — Pharmacokinetic and Subjective Effects of Heated Tobacco Products · NA · completed
Other recruiting trials for Smoking
Currently open trials in the same condition.
- NCT07488741 — Comparison of the Effects of Different Chest Techniques on University Students With Smoking Addiction · NA · recruiting
- NCT07443631 — Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants · NA · recruiting
- NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
- NCT06966258 — Inspire HER: Inspiring the Heart and Emotions for Radical Health · NA · recruiting
- NCT06713603 — Technology Assisted Motivational Interviewing · NA · recruiting
Other RAI Services Company trials
Trials by the same sponsor.
- NCT07323563 — A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems · NA · not yet recruiting
- NCT07323511 — Abuse Liability for Eight Electronic Nicotine Products · NA · not yet recruiting
- NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
- NCT07172438 — A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers · NA · terminated
- NCT07175987 — A Consumer Use Behavior Study to Evaluate Puffing Topography and Average Daily Consumption of Heated Tobacco Products · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04167384 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RAI Services Company
- Last refreshed: 12 March 2020
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/NCT04167384.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing