NCT00313105

Brief Summary

To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches. Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

4 years

First QC Date

April 10, 2006

Last Update Submit

September 14, 2009

Conditions

Tobacco Dependence

Keywords

smoking cessationsmokeless tobacconicotine patchnicotine buccal tabletsretreatmentadherence

Outcome Measures

Primary Outcomes (1)

  • Abstinence from smoking after ½ year (point and continuous abstinence)

    6 months from entry

Secondary Outcomes (5)

  • Adverse events between 3 arms

    Up to 6 months from entry

  • Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)

    3 and 6 months from entry

  • Adherence to study

    6,12,24 months from entry

  • Effect of retreatment (abstinence after 1, 1½ and 2 years)

    12,18 and 24 months from entry

  • Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status

    6,12,24 months from entry

Study Arms (3)

Smokeless Tobacco

EXPERIMENTAL

Smokeless Tobacco and individual visits

Drug: Smokeless tobacco (Oliver Twist pellets)Behavioral: smoking cessation counseling

Nicotine tablets

ACTIVE COMPARATOR

Nicotine tablets

Behavioral: smoking cessation counseling

3

PLACEBO COMPARATOR

7-mg nicotine patch acts as placebo

Behavioral: smoking cessation counseling

Interventions

Smokeless tobacco (Oliver Twist pellets)DRUG

individual visits with counseling

Smokeless Tobacco
smoking cessation counselingBEHAVIORAL

individual visits

3Nicotine tabletsSmokeless Tobacco

Eligibility Criteria

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

You may qualify if:

  • smokers (\>7 cig/day)
  • Healthy
  • Allowed: treated hypertension, diabetes treated with tablets, increased cholesterol,other "mild" diseases
  • mild asthma and COPD,
  • Motivated to quit smoking
  • Motivated to follow the protocol
  • Motivated to use medication in this trial

You may not qualify if:

  • Severe diseases
  • Psychiatric diseases
  • Used NRT or Zyban the last 2 weeks
  • Stopped smoking \>2 days during last 3 months
  • More than 6 alcoholic drinks per day
  • Smokes other products than cigarettes
  • Pregnant of lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. pulmonary medicine Y, Gentofte University Hospital

Copenhagen, Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmoking CessationTobacco Use

Interventions

Tobacco, Smokeless

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Tobacco ProductsSmoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Philip Tønnesen, M.D., Ph.D.

    Chair dept. pulm. medicine, Gentofte Hospital

    PRINCIPAL INVESTIGATOR

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

April 10, 2006

First Posted

April 11, 2006

Study Start

April 1, 2006

Primary Completion

April 1, 2010

Study Completion

August 1, 2010

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

DK(1)