MRS Probe Study of Alcohol

Not Applicable

Completed

• Conditions: Heavy Dose Drinkers

• Registration Number: NCT01679444
• Lead Sponsor: Mayo Clinic

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-31
• Study First Posted: 2012-09-06
• Primary Completion: 2014-03
• Status Verified: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-27
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States