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Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00317213
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : April 14, 2008
Modus Biological Membranes, Ltd.
Information provided by:
Kaplan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Drug: LIBERTAL- a phospholipid mixture Phase 2

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  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation
Study Start Date : February 2002
Estimated Study Completion Date : July 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
  2. Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.

Secondary Outcome Measures :
  1. Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00317213

Arazi Clinic and Modus Clinic
Tel-Aviv and Rehovot, Israel
Sponsors and Collaborators
Kaplan Medical Center
Modus Biological Membranes, Ltd.
Principal Investigator: Zeev T. Handzel, M.D. Kaplan Medical Center
Study Director: Avner Shenfeld, Ph.D, Modus Biological Membranes Identifier: NCT00317213     History of Changes
Other Study ID Numbers: LIB-05-2001
First Posted: April 24, 2006    Key Record Dates
Last Update Posted: April 14, 2008
Last Verified: April 2008

Keywords provided by Kaplan Medical Center:
Cell membrane fluidity
Smoking cessation