SmokingPhase 2NCT00317213
Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture
A Phase 2 study testing LIBERTAL- a phospholipid mixture in people with Smoking, run by Kaplan Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- LIBERTAL- a phospholipid mixture
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2002to Jul 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- LIBERTAL- a phospholipid mixture
- Keywords
- Smoking, Nicotine, Withdrawal, Phospholipids, Cell membrane fluidity, Smoking cessation
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIBERTAL- a phospholipid mixtureDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startFeb 2002
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Modus Biological Membranes, Ltd.
- Investigators
- Zeev T. Handzel, M.D., Principal investigator, Kaplan Medical CenterAvner Shenfeld, Ph.D,, Study director, Modus Biological Membranes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317213
- Sponsor's protocol ID
- LIB-05-2001
- Status last verified
- Apr 2008
- First submitted
- 20 Apr 2006
- Last updated
- 14 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation
- ClinicalTrials.gov ID
- NCT00317213
- Acronym / sponsor ID
- LIB-05-2001
- Conditions
- Smoking
- Keywords
- Smoking, Nicotine, Withdrawal, Phospholipids, Cell membrane fluidity, Smoking cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Collaborators
- Modus Biological Membranes, Ltd.
- Study start
- Feb 2002
- Study completion
- Jul 2002
- First posted
- 24 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIBERTAL- a phospholipid mixture | Drug | – |
Primary outcome
Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.
1 secondary outcome
Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2008.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeev T. Handzel, M.D. principal investigator
Kaplan Medical Center
Avner Shenfeld, Ph.D, study director
Modus Biological Membranes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LIBERTAL- a phospholipid mixture in people with Smoking, run by Kaplan Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2008.