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In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users

NCT01838473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-04-24

No results posted yet for this study

Summary

In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

Conditions

  • Smoking Cessation
  • Harm Reduction

Interventions

PROCEDURE

Buccal Administration of nicotine

Oral pouch 1g, single dose. One pouch administered over 30 minutes.

PROCEDURE

Buccal Administration of nicotine

Oral pouch 1g, single dose. One pouch administered over 30 minutes.

PROCEDURE

Buccal Administration of nicotine

Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.

PROCEDURE

Buccal Administration of nicotine

Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.

Sponsors & Collaborators

  • Swedish Match AB

    collaborator INDUSTRY

  • Contract Research Organization el AB

    lead INDUSTRY

Principal Investigators

  • Erik Lunell, MD, PhD · Croel AB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2004-08-31
Completion
2005-04-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01838473 on ClinicalTrials.gov