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Niacin Flushing as Marker of Cannabis Effects on Arachidonic Acid Pathways in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00376233
First Posted: September 14, 2006
Last Update Posted: October 12, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Jena
  Purpose

Increasing evidence suggests modulating effects of cannabinoids on time of onset, severity, and outcome of schizophrenia. Efforts to discover the underlying pathomechanism have led to the assumption of gene x environment interactions including premorbid genetical vulnerability and worsening effects of continuing cannabis use. For a main characteristic of psychoactive delta-9-tetrahydrocannabinol is its affinity to biological membranes, which are known to be disturbed in schizophrenia patients and genetic high-risk populations.

Here we assess an hypothesised association between premorbid lipid disturbance and metabolic effects of external cannabinoids in schizophrenia.

Intensity of niacin (methylnicotinate) skin flushing, indicating disturbed prostaglandin-mediated processes, is used as peripheral marker of lipid-arachidonic acid pathways and investigated in cannabis consuming and non-consuming schizophrenia patients and in healthy controls. Methylnicotinate is applied in three concentrations onto the forearm skin. Flush response is assessed in three minute intervals over 15 min using optical reflection spectroscopy.


Condition
Schizophrenia Cannabis Abuse

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: First Detailed Study on Effects of Long Term Regular Cannabis Use on Arachidonic Acid-Prostaglandine Pathways in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Jena:

Estimated Enrollment: 100
Study Start Date: February 2004
Estimated Study Completion Date: June 2005
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients:

  • acutely ill
  • consecutively admitted
  • diagnosis of schizophrenia according to DSM-IV criteria for paranoide schizophrenia.
  • not treated or treated with atypical neuroleptic drugs
  • cannabis use on a regular basis (≥ 0,5 g/d, at least 3 month) prior to admission or
  • never use of cannabis apart from unique trials
  • no use of any other drug or alcohol on a regular basis.

Controls:

  • healthy volunteers recruited by newspaper advertisement
  • cannabis user (duration and dose of cannabis use as in patients)or
  • no cannabis experience at all

All cannabis consuming participants:

  • positive for cannabinoids in urine test at the time of niacin testing

Exclusion Criteria:

Controls:

  • current psychiatric diagnosis or psychiatric personal or family history.

All individuals:

  • any current or history of skin disorders (eczema, atopical dermatitis, psoriasis)
  • recent treatment with steroids or non-steroidal antiinflammatory drugs (e.g. acetylsalicylic acid)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376233


Locations
Germany
University of Jena, Department of Psychiatry
Jena, Thueringen, Germany, D-07743
Sponsors and Collaborators
University of Jena
Investigators
Study Director: Heinrich Sauer, PhD University of Jena
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00376233     History of Changes
Other Study ID Numbers: SMCANNIACIN
First Submitted: September 13, 2006
First Posted: September 14, 2006
Last Update Posted: October 12, 2006
Last Verified: September 2006

Keywords provided by University of Jena:
Schizophrenia,
Cannabinoids,
Arachidonic Acid,
Niacin,
Prostaglandins

Additional relevant MeSH terms:
Schizophrenia
Marijuana Abuse
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders


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