NCT00317213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2006

Completed
Last Updated

April 14, 2008

Status Verified

April 1, 2008

First QC Date

April 20, 2006

Last Update Submit

April 9, 2008

Conditions

Smoking

Keywords

SmokingNicotineWithdrawalPhospholipidsCell membrane fluiditySmoking cessation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants

Interventions

LIBERTAL- a phospholipid mixtureDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arazi Clinic and Modus Clinic

Tel-Aviv and Rehovot, Israel

Location

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Zeev T. Handzel, M.D.

    Kaplan Medical Center

    PRINCIPAL INVESTIGATOR

  • Avner Shenfeld, Ph.D,

    Modus Biological Membranes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2006

First Posted

April 24, 2006

Study Start

February 1, 2002

Study Completion

July 1, 2002

Last Updated

April 14, 2008

Record last verified: 2008-04

Locations

IL(1)