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

Primary Purpose

Tobacco Dependence

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
support and visits
varenicline
placebo
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring long term nicotine gum use, varenicline, adverse effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Gentofte HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

varenicline

placebo

Arm Description

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

Placebo for 12 weeks

Outcomes

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

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

Full Information

First Posted
September 14, 2009
Last Updated
September 14, 2009
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00977249
Brief Title
Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users
Official Title
Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
long term nicotine gum use, varenicline, adverse effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
varenicline
Arm Type
Active Comparator
Arm Description
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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
support and visits
Intervention Description
visits at weeks 0,2,4,6,9 and 12 and 12 months
Intervention Type
Drug
Intervention Name(s)
varenicline
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Tønnesen, M.D:
Phone
+4539773508
Email
philipt@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Helle Johnson, reg. nurse
Phone
+4539773512
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Tønnesen, M.D.
Organizational Affiliation
Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gentofte Hospital
City
Copenhagen
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helle Johnson, reg Nures
Phone
+4539773512
First Name & Middle Initial & Last Name & Degree
Helle Johnson, reg.nures
First Name & Middle Initial & Last Name & Degree
Philip Tønnesen, M.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
23024246
Citation
Tonnesen P, Mikkelsen K. Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial. Nicotine Tob Res. 2013 Feb;15(2):419-27. doi: 10.1093/ntr/nts146. Epub 2012 Sep 27.
Results Reference
derived

Learn more about this trial

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

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