- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00317213
Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture
April 9, 2008 updated by: Kaplan Medical Center
Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation
It has been shown in rodent models that chronic substance abuse is associated with a rigidification of cell membrane fluidity due to a change in the membrane cholesterol/phospholipids ratio.
Upon substance withdrawal the membrane undergoes reequilibration of this ratio, a process resulting both in an acute and a prolonged severe withdrawal syndrome.
MBM has developed a patented,phosphatidic acid-enriched phospholipid platform ("LIBERTAL"), which is supposed to facilitate the membrane fluidity recovery.
The company has focused on nicotine withdrawal in smoking cessation,as primary target.
Study Overview
Detailed Description
A randomized,double-blind, dose-finding,phase IIB study with Libertal has been performed in 493 volunteer smokers, wishing to quit.
They were divided into 5 arms: 4 treatment groups of 0.5, 1.0, 2.0 and 4.0g/day respectively, and one placebo, divided BID.
Treatment was administered during one week prior to smoking cessation, then continued during 8 weeks (56 days), followed by another 4 weeks without treatment (up to day 84).
The primary endpoint was complete smoking cessation during at least 28 consecutive days.
There were 6 on-site visits and 4 telephone interviews.
Study Type
Interventional
Enrollment
500
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tel-Aviv and Rehovot, Israel
- Arazi Clinic and Modus Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Smokers of at least 1 year duration
- Smoking at least 10 cigarettes/day
- Having failed at least one previous smoking cessation effort.
- Without a major cardio-vascular or metabolic disease or condition.
Exclusion Criteria:
- An uncontrolled major cardiovascular, metabolic, or other condition condition.
- Need for surgery during the period of participation in the trial.
- Any treatment for smoking cessation during the 2 months preceding enrollment in the present trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
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Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.
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Secondary Outcome Measures
Outcome Measure |
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Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zeev T. Handzel, M.D., Kaplan Medical Center
- Study Director: Avner Shenfeld, Ph.D,, Modus Biological Membranes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2002
Study Completion
July 1, 2002
Study Registration Dates
First Submitted
April 20, 2006
First Submitted That Met QC Criteria
April 20, 2006
First Posted (Estimate)
April 24, 2006
Study Record Updates
Last Update Posted (Estimate)
April 14, 2008
Last Update Submitted That Met QC Criteria
April 9, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- LIB-05-2001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Jennifer Marler, MDCompletedSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsUnited States
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AronPharma Sp. z o. o.Recruiting
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Medical University of ViennaCompleted
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Azienda USL ModenaCompleted