Smoking
Conditions
Keywords
Smoking, Nicotine, Withdrawal, Phospholipids, Cell membrane fluidity, Smoking cessation
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.
Interventions
DRUGLIBERTAL- a phospholipid mixture
Sponsors
Modus Biological Membranes, Ltd.
Kaplan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants | — |
Countries
Israel
Outcome results
None listed