Last reviewed · How we verify
NCT01838460
Elevated Dose of Sublingual Nicotine Tablets Compared With Swedish Snus. Nicotine Pharmacokinetics and Subjective Effects of Single Doses.
Phase 1/Phase 2 trial testing sublingual nicotine tablets in Smoking Cessation in 16 participants. Completed in 1 February 2013.
1 August 2012
Quick facts
| Lead sponsor | Contract Research Organization el AB |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 1 May 2012 |
| Primary completion | 1 August 2012 |
| Estimated completion | 1 February 2013 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- sublingual nicotine tablets — full drug profile →
- Smokeless tobacco — full drug profile →
Conditions studied
- Smoking Cessation — all drugs for Smoking Cessation →
Sponsor
Contract Research Organization el AB — full company profile →
Who can join
Adults 18 to 50, any sex, with Smoking Cessation. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
AUCinf
Time frame: 6 hours
Sponsor's own description
To compare each subject's AUCinf, after administration of one single dose of 6 mg of Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of SS containing 16 mg nicotine.
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 NCT01838460
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Smoking Cessation
Currently open trials in the same condition.
- NCT07420621 — Preliminary Effectiveness of Enhanced Text Message + Incentives · NA · recruiting
- NCT07224087 — Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients · Phase 1 · recruiting
- NCT07331519 — Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer · NA · recruiting
- NCT07210567 — Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors · NA · recruiting
- NCT07129590 — Trauma-Informed Care for Smoking Cessation for Pregnancy · NA · recruiting
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 NCT01838460 (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 Contract Research Organization el AB
- Last refreshed: 19 April 2013
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/NCT01838460.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing