Smoking Cessation in Groups and With Tobacco Pastils | NCT00265460

Studies
Smoking Cessation in Groups and With Tobacco Pastils

NCT00265460

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Completed

Last Update Posted

Sep 15, 2009Estimated

Enrollment

240

Phase

Phase 2

Conditions

Smoking

Interventions

Oliwer Twist smokeless tobacco (tobacco)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Dec 13, 2005

First Submission Date that Met QC Criteria

Dec 13, 2005

First Posted Date

Dec 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2009

Last Update Posted Date

Sep 15, 2009Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240

Name	Type	Description	Arm Group Labels	Other Names
Oliwer Twist smokeless tobacco (tobacco)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Continuous Smoking cessation quit rate after 6 and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Side effects from tested tobacco product
Intake of nicotine and thiocyanate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Tønnesen, M.D., Ph.D.	Chair dept. pulm. medicine, Gentofte Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. pulmonary medicine Y, Gentofte University Hospital		Copenhagen	Hellerup	2900	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18686184	Result	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.

ID	Term
D012907	Smoking
D016540	Smoking Cessation
D064424	Tobacco Use

ID	Term
D001519	Behavior
D015438	Health Behavior

ID	Term
D000074602	Smoking Devices
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture