AnandamideNCT02727023
Effect of OMM on Anandamide Levels in Saliva
A study testing Osteopathic Manipulative Medicine in people with Anandamide and Endocannabinoids, run by New York Institute of Technology at 1 site in United States.
Trial summary
The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure the canabinomimetic effects of osteopathic treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anandamide, Endocannabinoids
- What is being tested?
- Osteopathic Manipulative Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Sep 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Accepts healthy volunteers.
- Able to read and understand scale for survey.
- BMI (Body Mass Index) TBD- BMI between 18 and 25 kg/m2 Signed informed consent No exercising on the day of or day before the appointment Age 18 and above.
Who cannot join
- smoker
- Neuropsychiatric disorders
- Autoimmune Disorders
- Unavailable 8AM-12PM
- No Illicit drug use, including exogenous cannabis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteopathic Manipulative Lymphatic Pump Technique and Its Effects to the Endocannabinoid System Activity as Measured by AEA Levels Via Mass Spectrometry and Mood Analogue Scale
The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure the canabinomimetic effects of osteopathic treatment.
Read the detailed description
The Endocannabinoid System is a signaling system composed of: 2 G-Protein coupled receptors (CB1 and CB2), substances acting on the cannabinoid receptors, and the enzymes and proteins involved in regulating endocannabinoids in tissue and at the receptors. The substances acting the cannabinoid receptors CB1 and CB2 are called endocannabinoids. The present study examines the effects of Osteopathic Manipulative Lymphatic Pump Techniques on levels of anandamide, an endocannabinoid, in saliva samples of adult subjects. Based on existing research, the investigators hypothesize that subjects who undergo osteopathic lymphatic treatment will have increased levels of anandamide. Establishing the levels of endocannabinoids in these subjects will allow for a direct measure of the efficacy of the Osteopathic Manipulative Lymphatic techniques. In addition to the quantification of endocannabinoid levels in saliva, a series of 16, 100 mm analog scales will be used to assess the cannabinomimetic effects in the subject pre and post OMM treatment/control and it will be correlated to changes in endocannabinoid levels.
- Conditions
- Anandamide, Endocannabinoids
- Being tested
- Osteopathic Manipulative Medicine
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative MedicineOther
The procedures are picked for their generalized effect on the lymphatic system based on osteopathic literature and research. Our goal is to mobilize the lymphatic fluid to induce an increase of endocannabinoids. These procedures are similar to mechanical motion seen in exercise in regards to lymphatic movement. Each technique will be performed for a total of four minutes each
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Medicine | Experimental | The thoracic inlet release, The Miller Thoracic Pump, Pedal Pump will be performed. These techniques are gentle and would be rhythmic in motion. Receives: Other: Osteopathic Manipulative Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteopathic Manipulative Lymphatic Pump Treatment and Its Relationship To Anandamide levels
The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure the canabinomimetic effects of osteopathic treatment.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionAug 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnandamideStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Cold Spring Harbor Laboratory
- Responsible party
- Sponsor
- Investigators
- George Cheriyan, DO, Principal investigator, NYIT-COM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727023
- Sponsor's protocol ID
- BHS-1152
- Status last verified
- Oct 2017
- First submitted
- 19 Jan 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Lymphatic Pump Technique and Its Effects to the Endocannabinoid System Activity as Measured by AEA Levels Via Mass Spectrometry and Mood Analogue Scale
- ClinicalTrials.gov ID
- NCT02727023
- Acronym / sponsor ID
- BHS-1152
- Conditions
- Anandamide, Endocannabinoids
- Keywords
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Collaborators
- Cold Spring Harbor Laboratory
- Study start
- Dec 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Apr 2016 (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.
The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure the canabinomimetic effects of osteopathic treatment.
Detailed description
The Endocannabinoid System is a signaling system composed of: 2 G-Protein coupled receptors (CB1 and CB2), substances acting on the cannabinoid receptors, and the enzymes and proteins involved in regulating endocannabinoids in tissue and at the receptors. The substances acting the cannabinoid receptors CB1 and CB2 are called endocannabinoids. The present study examines the effects of Osteopathic Manipulative Lymphatic Pump Techniques on levels of anandamide, an endocannabinoid, in saliva samples of adult subjects. Based on existing research, the investigators hypothesize that subjects who undergo osteopathic lymphatic treatment will have increased levels of anandamide. Establishing the levels of endocannabinoids in these subjects will allow for a direct measure of the efficacy of the Osteopathic Manipulative Lymphatic techniques. In addition to the quantification of endocannabinoid levels in saliva, a series of 16, 100 mm analog scales will be used to assess the cannabinomimetic effects in the subject pre and post OMM treatment/control and it will be correlated to changes in endocannabinoid levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Medicine | Experimental | Other: Osteopathic Manipulative MedicineThe thoracic inlet release, The Miller Thoracic Pump, Pedal Pump will be performed. These techniques are gentle and would be rhythmic in motion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Accepts healthy volunteers.
- Able to read and understand scale for survey.
- BMI (Body Mass Index) TBD- BMI between 18 and 25 kg/m2 Signed informed consent No exercising on the day of or day before the appointment Age 18 and above.
Key exclusion criteria (5 listed)
- smoker
- Neuropsychiatric disorders
- Autoimmune Disorders
- Unavailable 8AM-12PM
- No Illicit drug use, including exogenous cannabis.
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 |
|---|---|---|
| Osteopathic Manipulative MedicineThe procedures are picked for their generalized effect on the lymphatic system based on osteopathic literature and research. Our goal is to mobilize the lymphatic fluid to induce an increase of endocannabinoids. These procedures are similar to mechanical motion seen in exercise in regards to lymphatic movement. Each technique will be performed for a total of four minutes each | Other | Osteopathic Manipulative Medicine |
Primary outcome
Osteopathic Manipulative Lymphatic Pump Treatment and Its Relationship To Anandamide levels
Time frame: 60 minutes
The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure the canabinomimetic effects of osteopathic treatment.
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 5 Oct 2017.
- Individual participant dataSharing planned: No
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.
George Cheriyan, DO principal investigator
NYIT-COM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Medicine in people with Anandamide and Endocannabinoids, run by New York Institute of Technology at 1 site in United States.
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 3 inclusion and 5 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 5 Oct 2017. 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 United States. 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.
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?
Osteopathic Manipulative Lymphatic Pump Treatment and Its Relationship To Anandamide levels (time frame: 60 minutes). 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 5 Oct 2017.