Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture
- Conditions
- Smoking
- Registration Number
- NCT00317213
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants
Trial Locations
- Locations (1)
Arazi Clinic and Modus Clinic
🇮🇱Tel-Aviv and Rehovot, Israel
Arazi Clinic and Modus Clinic🇮🇱Tel-Aviv and Rehovot, Israel