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MRS Probe Study of Alcohol

This study has been completed.
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic Identifier:
First received: August 30, 2012
Last updated: June 27, 2014
Last verified: June 2014
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 Intervention
Heavy Dose Drinkers Procedure: Magnetic Resonance Spectroscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Magnetic Resonance Spectroscopy Probe Study of Alcohol Use

Further study details as provided by Mark Frye, Mayo Clinic:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 40
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Magnetic Resonance Spectroscopy
    Other Name: MRS

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

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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Please refer to this study by its identifier: NCT01679444

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Mark Frye, MD Mayo Clinic
  More Information

Responsible Party: Mark Frye, Principal Investigator, Mayo Clinic Identifier: NCT01679444     History of Changes
Other Study ID Numbers: 12-003693
Study First Received: August 30, 2012
Last Updated: June 27, 2014

Keywords provided by Mark Frye, Mayo Clinic:
Heavy dose drinkers

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on September 18, 2017