MRS Probe Study of Alcohol

NCT01679444 | Completed

• 1 other identifier: 12-003693
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Heavy Dose Drinkers

Keywords

MRS; Heavy dose drinkers; Alcohol; NIAAA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the relationship between these metabolites, each reported as a Cerebrospinal Fluid-corrected absolute concentration, and severity of alcohol cravings

Interventions

Magnetic Resonance Spectroscopy PROCEDURE

Also known as: MRS

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 21-70
• Consume less alcohol then what is described in this protocol as a "higher dose drinker", or consume no alcohol at all.
• Able to complete a 60 min. MRS brain scan.

You may not qualify if:

• Inability to speak English
• Inability or unwillingness to provide written informed consent
• 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.
• Any unstable active medical or additional psychiatric condition as determined by the investigator
• 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).
• History of encephalopathy, hepatic failure, or HIV seropositivity
• History of claustrophobia
• History of major head trauma with loss of consciousness \>5 minutes or skull fracture
• History of previous neurological event (e.g. epilepsy, stroke, transient ischemic attack)
• Implanted metal objects (e.g. pacemakers; aneurysm clips; metal prostheses, joints, rods, or plates)
• Contraindication to MRI scanning
• Pregnancy or breast-feeding

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Mark Frye, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 6, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 30, 2014

Record last verified: 2014-06

Locations

US (1)