Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00977249
First received: September 14, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.


Condition Intervention Phase
Tobacco Dependence
Behavioral: support and visits
Drug: varenicline
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml [ Time Frame: 12 weeks +/- 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • is not smoking and not using NRT at 12 months (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml [ Time Frame: 12 months +/- 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varenicline

Varenicline for 12 weeks.

The treatment schedule for varenicline is:

Varenicline tablets, 0.5 mg x 1 daily, day 1-3 Varenicline 0.5 mg x 2, day 4-6 Varenicline 1 mg x 2, day 7 up to 12 weeks

Behavioral: support and visits
visits at weeks 0,2,4,6,9 and 12 and 12 months
Drug: varenicline
Placebo Comparator: placebo
Placebo for 12 weeks
Behavioral: support and visits
visits at weeks 0,2,4,6,9 and 12 and 12 months
Drug: placebo

Detailed Description:

100-200 long-term users of NRT will be enrolled in a placebo, controlled, randomized trial with varenicline or placebo for 12 weeks to stop the use of NRT.

Assessments consist of carbon monoxide in expired air, p-cotinine, body-weight, questions about craving, nausea and dreams. Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) and secondary result is not smoking and not using NRT at 12 months. Secondary aims, is a more detailed assessment of nausea and dreams; well-known side effects of varenicline and secondary results are a qualitative description of nausea and dreams.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Long-term, daily NRT users (except nicotine patch) (>11 months) ex-smokers that are willing to try to stop the use of NRT and adhere to this protocol.
  • More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day, OR more than 3 inhaler cylinders per day, OR
  • more than 10 puffs of nasal spray per day.

Exclusion Criteria:

  • Age < 18 years,
  • CO Smokers,
  • Pregnant and lactating women,
  • Used varenicline before,
  • Not able to cooperate,
  • Other significant diseases that might influence the trial (such as moderate -severe cardiac disease, lung cancer,) in expired air > 7 ppm.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977249

Contacts
Contact: Philip Tønnesen, M.D: +4539773508 philipt@dadlnet.dk
Contact: Helle Johnson, reg. nurse +4539773512

Locations
Denmark
Gentofte Hospital Recruiting
Copenhagen, Hellerup, Denmark, 2900
Contact: Helle Johnson, reg Nures    +4539773512      
Contact: Helle Johnson, reg.nures         
Principal Investigator: Philip Tønnesen, M.D         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Pfizer
Investigators
Principal Investigator: Philip Tønnesen, M.D. Gentofte Hospital
  More Information

No publications provided by University Hospital, Gentofte, Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Physician Philip Tønnesen, M.D., Gentofte University Hospital
ClinicalTrials.gov Identifier: NCT00977249     History of Changes
Other Study ID Numbers: EudraCTnumber 2008-006426-24
Study First Received: September 14, 2009
Last Updated: September 14, 2009
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:
long term nicotine gum use
varenicline
adverse effects

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014