NCT01838473

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

3 months

First QC Date

February 10, 2012

Last Update Submit

April 19, 2013

Conditions

Smoking CessationHarm Reduction

Keywords

smokeless tobaccoNicotineCadmiumleadTobacco Specific Nitrosamines

Outcome Measures

Primary Outcomes (1)

  • In-vivo extraction of cadmium

    Extracted amount = mean of 10 unused sachets - residual amount

    30 minutes' use

Secondary Outcomes (3)

  • in-vivo extraction of tobacco specific nitrosamines (TSNAs)

    30 minutes' use

  • In-vivo extraction of lead

    30 minutes' use

  • In-vivo extraction of nicotine

    30 minutes' use

Study Arms (4)

General 1 g pouch

ACTIVE COMPARATOR

Oral pouch 0.3-1g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine.

Procedure: Buccal Administration of nicotine

Catch Licoice 1 g pouch

ACTIVE COMPARATOR

Oral pouch 1g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine.

Procedure: Buccal Administration of nicotine

Catch Licorice Mini 0.5 g pouch

ACTIVE COMPARATOR

Oral pouch 0.5g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine.

Procedure: Buccal Administration of nicotine

Catch Licorice dry mini 0.3 g pouch

ACTIVE COMPARATOR

Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine.

Procedure: Buccal Administration of nicotine

Interventions

Buccal Administration of nicotinePROCEDURE

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

Also known as: Smokeless tobacco, ST, Potential Exposure Reduced Product, PREP
General 1 g pouch

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non-smokers, 18 to 50 years of age.
  • Habitual use of \> 7 portions snus daily since minimum 1 year.
  • Healthy according to the health declaration and interview.
  • Written informed consent given.

You may not qualify if:

  • Concurrent participation in another clinical trial.
  • History of allergy.
  • History of allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CROel AB

Helsingborg, SE25284, Sweden

Location

MeSH Terms

Conditions

Smoking CessationHarm ReductionTobacco Use

Interventions

Tobacco, Smokeless

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Tobacco ProductsSmoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Erik Lunell, MD, PhD

    Croel AB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 10, 2012

First Posted

April 24, 2013

Study Start

May 1, 2004

Primary Completion

August 1, 2004

Study Completion

April 1, 2005

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations

SE(1)