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MRS Probe Study of Alcohol

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.
 
ClinicalTrials.gov Identifier: NCT01679444
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : June 30, 2014
Sponsor:
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic

Study Description
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Brief Summary:
This protocol will investigate the neurobiological underpinnings of alcohol craving in recently detoxified alcoholic drinkers utilizing novel functional brain imaging. This clinical magnetic resonance spectroscopy (MRS) study will investigate whether glutamate and other brain metabolites correlate to measures of alcohol craving severity

Condition or disease Intervention/treatment Phase
Heavy Dose Drinkers Procedure: Magnetic Resonance Spectroscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Magnetic Resonance Spectroscopy Probe Study of Alcohol Use
Study Start Date : August 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014
Arms and Interventions
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Intervention Details:
  • Procedure: Magnetic Resonance Spectroscopy
    Other Name: MRS

Outcome Measures
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Primary Outcome Measures :
  1. Utilizing Magnetic Resonance Spectroscopy at 3 Tesla, investigate the neurobiological underpinnings of alcohol craving
    assessing baseline perturbations in anterior cingulate and ventral striatal metabolites (NAA levels, glutamate levels, glutamine levels)


Secondary Outcome Measures :
  1. Evaluate the relationship between these metabolites, each reported as a Cerebrospinal Fluid-corrected absolute concentration, and severity of alcohol cravings
    Evaluate the relationship between these metabolites, each reported as a Cerebrospinal fluid-corrected absolute concentration, and severity of alcohol cravings, as measured primarily by the Penn Alcohol Craving Scale and secondarily by the Inventory of Drug Taking Situations.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: (Minimal or No Alcohol Group)

  1. Male or female age 21-70
  2. Consume less alcohol then what is described in this protocol as a "higher dose drinker", or consume no alcohol at all.
  3. Able to complete a 60 min. MRS brain scan.

Exclusion Criteria:

  1. Inability to speak English
  2. Inability or unwillingness to provide written informed consent
  3. Diagnosis of active substance dependence other than nicotine (e.g. alcohol, cannabis, caffeine, prescription use of barbiturates, benzodiazepines, opiates, or stimulants) this will be determined using a PRISM (Psychiatric Research Interview for Substance and Mental Disorders) interview.
  4. Any unstable active medical or additional psychiatric condition as determined by the investigator
  5. Active suicidal ideation as determined by the PHQ-9 question 9 indicating response #2 or higher (several days; more than half the days; or nearly every day).
  6. History of encephalopathy, hepatic failure, or HIV seropositivity
  7. History of claustrophobia
  8. History of major head trauma with loss of consciousness >5 minutes or skull fracture
  9. History of previous neurological event (e.g. epilepsy, stroke, transient ischemic attack)
  10. Implanted metal objects (e.g. pacemakers; aneurysm clips; metal prostheses, joints, rods, or plates)
  11. Contraindication to MRI scanning
  12. Pregnancy or breast-feeding
Contacts and Locations
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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): NCT01679444


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Mark Frye, MD Mayo Clinic
More Information
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Responsible Party: Mark Frye, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01679444    
Other Study ID Numbers: 12-003693
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: June 30, 2014
Last Verified: June 2014
Keywords provided by Mark Frye, Mayo Clinic:
MRS
Heavy dose drinkers
Alcohol
NIAAA