MRS Probe Study of Alcohol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01679444
First received: August 30, 2012
Last updated: June 27, 2014
Last verified: June 2014
  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: Open Label
Official Title: Magnetic Resonance Spectroscopy Probe Study of Alcohol Use

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Utilizing Magnetic Resonance Spectroscopy at 3 Tesla, investigate the neurobiological underpinnings of alcohol craving [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mark Frye, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01679444     History of Changes
Other Study ID Numbers: 12-003693
Study First Received: August 30, 2012
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014