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Trial record 69 of 415 for:    shaare zedek

Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?

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ClinicalTrials.gov Identifier: NCT02634281
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

Brief Summary:

SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available cessation programs are not effective for all smokers, new strategies are necessary for tobacco control.

Primary objective: To investigate whether a 6-week varenicline preloading facilitates smoking reduction and cessation compared with the standard varenicline treatment schedule.

Design: Parallel group, double-blind, randomised controlled clinical trial. Participants: Smokers of both sexes from the general population. Methods: Participants will be randomized into two groups of treatment. Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day (QD)) and at week 1, 6, 12, and 24 after QD.

Measurements: These will include vital signs, smoking history, spirometry, expired CO, salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is continuous abstinence at 6 months.

Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects).

Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test (nominal variables) will be used as appropriate.

Expected benefits: This study might contribute to optimize the current use of varenicline.


Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Varenicline Drug: placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?
Actual Study Start Date : February 2016
Actual Primary Completion Date : June 28, 2018
Actual Study Completion Date : June 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: group A
Subjects in Group A will receive varenicline for six weeks .During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
Drug: Varenicline
Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
Other Names:
  • champix
  • chantix

Active Comparator: group B
group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
Drug: Varenicline
Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
Other Names:
  • champix
  • chantix

Drug: placebo
Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment




Primary Outcome Measures :
  1. Continuous abstinence [ Time Frame: from week 7 until week 24 ]
    defined as avoidance of tobacco (not a single puff) since the quit date. It will be assessed by self-reported complete abstinence and expired CO < 10 ppm from week 7 until endpoint. The occurrence of occasional lapses after week 7 will be categorised as a failure in the main evaluation, but will not necessitate withdrawal if the subject is willing to continue and is considered by the investigators as competent to succeed.


Secondary Outcome Measures :
  1. smoking reduction [ Time Frame: from week 7 until week 24 ]
    This will be measured by daily self-reported cigarettes per day and expired CO measures (at every visit). An efficient reduction will be defined by a diminution of at least 50% of the number of cigarettes smoked, together with a reduction in CO levels compared to baseline

  2. Decline in pulmonary function [ Time Frame: from week 7 until week 24 ]
    The rate of decline of spirometric parameters will be calculated separately for quitters, continuing smokers and reducers from the two groups, pooled together.

  3. adverse events [ Time Frame: from week 7 until week 24 ]
    The subjects will be asked about adverse events at each visit during treatment by an open-ended question. Serious adverse events are defined as events that are fatal or life threatening, permanently disabling, requiring or prolonging hospitalisation, cancer, congenital abnormality or overdose

  4. Symptoms and physical signs associated with withdrawal: MPSS questionnaire [ Time Frame: from week 7 until week 24 ]
    MPSS questionnaire

  5. Use of cigarettes [ Time Frame: from week 7 until week 24 ]
    For participants smoking at any time point the number of cigarettes smoked per day and the satisfaction (mCEQ questionnaire) will be assessed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women aged ≥18 years
  • Currently smoking 10 cigarettes per day or more
  • Having smoked 5 py or more
  • Presenting a CO level in expired air ≥ 10 ppm
  • Personally motivated to reduce or stop smoking and indicating a willingness to follow through with protocol requirements
  • Willing to sign a statement of informed consent

Exclusion Criteria:

  • Myocardial infarction within the last 3 months
  • Unstable angina
  • Severe cardiac arrhythmia
  • Pregnancy or breast feeding
  • Use of any form of smokeless tobacco or nicotine substitution
  • Having followed any smoking cessation programme during the last 3 months
  • Alcohol or other drug addiction
  • Use of any form of smokeless tobacco or nicotine substitution
  • Participation in any clinical trial within the past 3 months
  • Women in childbearing age not willing to use contraception until week 12 after QD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634281


Locations
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Israel
Shaare Zedek Medical center
Jerusalem, Israel, 9103102
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Abraham BOHADANA, MD Shaare zedek medical center, pulmonary institute

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Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02634281     History of Changes
Other Study ID Numbers: 0239-15-SZMC
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs