Smoking Cessation in Groups and With Tobacco Pastils

Smoking Clinical Trial

Official title:

Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265460
• Other study ID #: Tonga.2005.00.
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2005
• Last updated: September 14, 2009
• Start date: March 2005
• Est. completion date: November 2006

Study information

• Verified date: September 2009
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with group support (15-20 per group) might increase smoking cessation rate compared with groups support cold turkey in smokers.The test product should be used for 7 weeks. Seven group meetings are planned during the first 3 months followed bu follow-up sessions after 6 and 12 months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight, carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• Oliwer Twist smokeless tobacco (tobacco)

Locations

Country	Name	City	State
Denmark	Dept. pulmonary medicine Y, Gentofte University Hospital	Copenhagen	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Tønnesen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Smoking cessation quit rate after 6 and 12 months
Secondary	Side effects from tested tobacco product
Secondary	Intake of nicotine and thiocyanate