Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation|
- Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
- Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.
- Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants
|Study Start Date:||February 2002|
|Estimated Study Completion Date:||July 2002|
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.
|Arazi Clinic and Modus Clinic|
|Tel-Aviv and Rehovot, Israel|
|Principal Investigator:||Zeev T. Handzel, M.D.||Kaplan Medical Center|
|Study Director:||Avner Shenfeld, Ph.D,||Modus Biological Membranes|