MRS Probe Study of Alcohol
This study is currently recruiting participants.
Verified March 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01679444
First received: August 30, 2012
Last updated: March 26, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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.
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (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)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679444
Locations
| United States, Minnesota | |
| Mayo Clinic in Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Lee J Gunderson, BS 507-255-6725 gunderson.lee@mayo.edu | |
| Contact: Michelle K Skime, BA 507-255-0501 skime.michelle@mayo.edu | |
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: | March 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
MRS Heavy dose drinkers Alcohol NIAAA |
ClinicalTrials.gov processed this record on May 22, 2013