Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation

Conditions
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Smoking

Intervention / Treatment
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* Drug: LIBERTAL- a phospholipid mixture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LIBERTAL- a phospholipid mixture|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Nicotine, Withdrawal, Phospholipids, Cell membrane fluidity, Smoking cessation