NCT00265460

Brief Summary

The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

First QC Date

December 13, 2005

Last Update Submit

September 14, 2009

Conditions

Smoking

Keywords

smoking cessation,nicotine,smokeless tobacco,cigarettes

Outcome Measures

Primary Outcomes (1)

  • Continuous Smoking cessation quit rate after 6 and 12 months

Secondary Outcomes (2)

  • Side effects from tested tobacco product

  • Intake of nicotine and thiocyanate

Interventions

Oliwer Twist smokeless tobacco (tobacco)DRUG

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • smoking \> 13 cigarettes/day
  • healthy (allowed: hypertension, diabetes type 2, mild asthma/COPD, hypercholesterolemia)
  • motivated for cessation
  • motivated to use tobacco pastils
  • motivated for group support

You may not qualify if:

  • severe diseases
  • psychiatric diseases
  • using antipsychotic drugs
  • used NRT/bupropion in the last 3 months
  • consuming \> 6 drinks/day
  • pregnant/lactating
  • stopped smoking more than 2 days during last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. pulmonary medicine Y, Gentofte University Hospital

Copenhagen, Hellerup, 2900, Denmark

Location

Related Publications (1)

  • Tonnesen P, Mikkelsen K, Bremann L. Smoking cessation with smokeless tobacco and group therapy: an open, randomized, controlled trial. Nicotine Tob Res. 2008 Aug;10(8):1365-72. doi: 10.1080/14622200802238969.

    PMID: 18686184RESULT

MeSH Terms

Conditions

SmokingSmoking CessationTobacco Use

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Philip Tønnesen, M.D., Ph.D.

    Chair dept. pulm. medicine, Gentofte Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 14, 2005

Study Start

March 1, 2005

Study Completion

November 1, 2006

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

DK(1)