Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2002-07-31

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.

Conditions

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Smoking

Keywords

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Smoking Nicotine Withdrawal Phospholipids Cell membrane fluidity Smoking cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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LIBERTAL- a phospholipid mixture

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Zeev T. Handzel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kaplan Medical Center

Avner Shenfeld, Ph.D,

Role: STUDY_DIRECTOR

Modus Biological Membranes

Locations

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Arazi Clinic and Modus Clinic

Tel-Aviv and Rehovot, , Israel

Site Status

Countries

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Israel

Other Identifiers

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LIB-05-2001

Identifier Type: -

Identifier Source: org_study_id