Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Completed
NCT Number: NCT01679444
MRS Probe Study of Alcohol
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
Completed
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Conditions
Age range
21 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Minimal or No Alcohol Group)
- 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.
Exclusion criteria
- 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
Treatment and study plan
Magnetic Resonance Spectroscopy
ProcedureOther names: MRS
Primary outcomes
-
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
-
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.
Sponsors and collaborators
Lead sponsor
Mayo Clinic
Other
Registry information
Official study title
Magnetic Resonance Spectroscopy Probe Study of Alcohol Use
Important dates
- Study start
- 2012
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Sep 6, 2012
- Registry last updated
- Jun 30, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.