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MRS Probe Study of Alcohol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679444
First Posted: September 6, 2012
Last Update Posted: June 30, 2014
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 (Responsible Party):
Mark Frye, Mayo Clinic
  Purpose
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
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
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
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Frye, MD Mayo Clinic
  More Information

Responsible Party: Mark Frye, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01679444     History of Changes
Other Study ID Numbers: 12-003693
First Submitted: August 30, 2012
First Posted: September 6, 2012
Last Update Posted: June 30, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs


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