Status:
COMPLETED
Characterization of [11C]Flumazenil to Image GABA Transmission in Healthy Adult Subjects and Subjects With Alcohol Dependence
Lead Sponsor:
Rajesh Narendran
Conditions:
Alcoholism
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Background: \- This study is being done to examine the role of a chemical GABA in the brain of alcohol dependent patients. GABA is the chief inhibitory neurotransmitter in the central nervous system....
Detailed Description
Objectives: \- By comparing the two PET scans (before and after tiagabine) done in the same day, we can understand more about how much GABA your brain makes and about the activity of your GABA recept...
Eligibility Criteria
Inclusion
- Healthy Control Subjects:
- Males or Females 18-45
- Absence of present or past psychiatric conditions (including alcohol or drug dependence)
- A negative urine drug screen
- Medically Healthy
- Subjects with alcohol dependence:
- Males or Females 18-45
- Fulfill DSM-IV Diagnosis for Alcohol Dependence
- Negative Urine Drug Screen
- Negative Urine ETG/ETS
- Medically Healthy
- Abstinent from alcohol for a minimum of 1 month prior to scanning procedures
Exclusion
- Healthy Control Subjects:
- Pregnancy or lactation, lack of effective birth control during 15 days before the scans
- Presence or positive history of serious medical or neurological illness, including low hemoglobin.
- Any use (within recent past 6 weeks) of amphetamines, opiates, cocaine, ecstasy PCP.
- Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan (but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant. Dental fillings do not present a risk for MRI), as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists.
- Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous research studies and this study) would exceed the radiation dose limits specified in the FDA regulations at 21 CFR 361.1, Radioactive Drugs Considered Generally Safe and Effective (i.e. annual cumulative radiation dose limit = 5 rems to gonads, blood-forming organs, lens of eye, whole body; 15 rems to other organs).
- Subjects with known hypersensitivity to flumazenil or benzodiazepines; subjects who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g., control of intracranial pressure or status epilepticus or in patient who are showing signs of serious cyclic antidepressant overdose)
- Subjects with alcohol dependence:
- Pregnancy or lactation, lack of effective birth control during 15 days before the scans
- Presence or positive history of serious medical or neurological illness or any cardiovascular disease, low hemoglobin
- Any other current major axis I psychiatric diagnosis except alcohol dependence (subjects with nicotine dependence will not be excluded)
- Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan (but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant. Dental fillings do not present a risk for MRI), as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists.
- Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous research studies and this study) would exceed the radiation dose limits specified in the FDA regulations at 21 CFR 361.1, Radioactive Drugs Considered Generally Safe and Effective (i.e. annual cumulative radiation dose limit = 5 rems to gonads, blood-forming organs, lens of eye, whole body; 15 rems to other organs).
- Subjects with known hypersensitivity to flumazenil or benzodiazepines; subjects who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g., control of intracranial pressure or status epilepticus or in patient who are showing signs of serious cyclic antidepressant overdose)
Key Trial Info
Start Date :
April 19 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01904487
Start Date
April 19 2011
End Date
October 1 2013
Last Update
August 29 2017
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213