Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture - Full Text View

Sponsors and Collaborators:	Kaplan Medical Center Avner Shenfeld PhD, Chief Scientific Officer of Modus Biological Membranes, Ltd.
Information provided by:	Kaplan Medical Center
ClinicalTrials.gov Identifier:	NCT00317213

Purpose

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	Intervention	Phase
Smoking	Drug: LIBERTAL- a phospholipid mixture	Phase II

MedlinePlus related topics: Quitting Smoking Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation

Further study details as provided by Kaplan Medical Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants

Estimated Enrollment:	500
Study Start Date:	February 2002
Estimated Study Completion Date:	July 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317213

Locations

Israel
Arazi Clinic and Modus Clinic
Tel-Aviv and Rehovot, Israel

Sponsors and Collaborators

Kaplan Medical Center

Avner Shenfeld PhD, Chief Scientific Officer of Modus Biological Membranes, Ltd.

Investigators

Principal Investigator:	Zeev T. Handzel, M.D.	Kaplan Medical Center
Study Director:	Avner Shenfeld, Ph.D,	Modus Biological Membranes

More Information

Study ID Numbers:	LIB-05-2001
Study First Received:	April 20, 2006
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00317213
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Kaplan Medical Center:

Smoking
Nicotine
Withdrawal

Phospholipids
Cell membrane fluidity
Smoking cessation

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Nicotine

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on February 11, 2009