Smoking Cessation in Groups and With Tobacco Pastils

• Sponsor: University Hospital, Gentofte, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00265460
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking	Drug: Oliwer Twist smokeless tobacco (tobacco)	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation
• Study Start Date: Mar 1, 2005
• Actual Study Completion Date: Nov 1, 2006

Outcome Measures

Primary Outcome Measures

1. Continuous Smoking cessation quit rate after 6 and 12 months []

Secondary Outcome Measures

1. Side effects from tested tobacco product []

2. Intake of nicotine and thiocyanate []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. pulmonary medicine Y, Gentofte University Hospital	Copenhagen	Hellerup	Denmark	2900

Sponsors and Collaborators

• University Hospital, Gentofte, Copenhagen

Investigators

• Study Chair: Philip Tønnesen, M.D., Ph.D., Chair dept. pulm. medicine, Gentofte Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00265460
• Other Study ID Numbers: Tonga.2005.00.
• First Posted: Dec 14, 2005
• Last Update Posted: Sep 15, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: smoking cessation,; nicotine,; smokeless tobacco,; cigarettes
• Additional relevant MeSH terms: Lobeline

Study Results

No Results Posted as of Sep 15, 2009