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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
August 30, 2012
September 6, 2012
June 30, 2014
August 2012
March 2014   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01679444 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
MRS Probe Study of Alcohol
Magnetic Resonance Spectroscopy Probe Study of Alcohol Use
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
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Heavy Dose Drinkers
Procedure: Magnetic Resonance Spectroscopy
Other Name: MRS
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01679444
12-003693
No
Not Provided
Not Provided
Mark Frye, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Mark Frye, MD Mayo Clinic
Mayo Clinic
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP