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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06303115
Other study ID # CSD231005 BoE
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 15, 2024
Est. completion date January 15, 2025

Study information

Verified date March 2024
Source RAI Services Company
Contact John Darnell
Phone 3367410386
Email csd201204actualusestudyemail@rjrt.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.


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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
United States Pillar Bentonville Bentonville Arkansas
United States AMR Knoxville Knoxville Tennessee
United States AMR Lexington Lexington Kentucky
United States Pillar Richardson Richardson Texas
United States QPS Missouri Springfield Missouri

Sponsors (1)

Lead Sponsor Collaborator
RAI Services Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL] 24 hour
Secondary 4Aminobiphenyl [4ABP] 24 hour
Secondary 1Aminonaphthalene [1AN] 24 hour
Secondary 2Aminonaphthalene [2AN] 24 hour
Secondary 2Cyanoethyl mercapturic acid [CEMA] 24 hour
Secondary 3Hydroxypropyl mercapturic acid [3HPMA] 24 hour
Secondary 3Hydroxy1methylpropylmercapturic acid [HMPMA] 24 hour
Secondary 3hydroxybenzo[a]pyrene [3-OH-B[a]P] 24 hour
Secondary 1hydroxypyrene [1OHP] 24 hour
Secondary Monohydroxybutyl mercapturic acid [MHBMA] 24 hour
Secondary Nnitrosonornicotine [NNN] + glucuronides [Total NNN] 24 hour
Secondary SPhenyl mercapturic acid [SPMA] 24 hour
Secondary Total nicotine equivalents (molar sum of nicotine, cotinine, 3hydroxycotinine and their glucuronides) [TNneq] 24 hour
Secondary Carboxyhemoglobin [COHb] 12 hour
Secondary Nnitrosonornicotine [NNN] + glucuronides [Total NNN] 12 hour
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