Status:
COMPLETED
OPRM1 A118G SNP, Alcohol Response, and Striatal Dopamine
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Eligibility:
All Genders
21-45 years
Brief Summary
This study will examine the relationship between variations in a gene called OPRM1 and the response to alcohol. The OPRM1 (Mu-opioid Receptor-1) gene helps regulate brain pathways involved in experien...
Detailed Description
Objectives: Reinforcing properties of alcohol are in part mediated through endogenous opioids. Mesolimbic dopamine (DA) release is a key signal for drug reward, and endogenous opioids are thought to ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Male and female participants between 21-45 years of age.
- Good health as determined by medical history, physical exam, EKG and lab tests.
- Social drinkers consuming less than 20 alcoholic beverages per week, on average, having normal liver enzymes and not seeking treatment for alcohol-related problems.
- Current non-smokers who have never smoked or quit at least a year prior to enrolling in the study.
- Females will have normal menstrual cycles and will be tested during the follicular phase of their cycle (within 15 days of offset of menses) and must have a negative urine pregnancy (hCG) test at the start of each study session.
- An equal number of final participants will be of OPRM1 118 A/A vs. 118A/G or 118G/G genotype.
- EXCLUSION CRITERIA:
- Current or prior history of any significant disease, including cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders, or a positive hepatitis or HIV test at screening.
- Current Axis-I psychiatric illness.
- Current or prior history of any alcohol or drug dependence, as well as non-drinkers (alcohol-naive individuals or current abstainers).
- Positive result on urine screen for illicit drugs.
- Nursing, pregnancy or intention to become pregnant for women. Female participants will undergo a clinical interview and a urine beta-hCG test to ensure they are not pregnant. If it is not possible to document non-pregnancy, the study will not be performed.
- Inability to undergo an MRI scan of the brain due to claustrophobia or anxiety when confined to small spaces such as the magnet bore, or due to the presence of metallic implants.
- Use of prescription or OTC medications known to interact with alcohol within 2 weeks of the study. These include, but may not be limited to: isosorbide, nitroglycerine, benzodiazepines, warfarin, anti-depressants such as amitriptyline, clomipramine and nefazodone, anti-diabetes medications such as glyburide, metformin and tolbutamide, H2-antagonists for heartburn such as cimetidine and ranitidine, muscle relaxants, anti-epileptics including phenytoin and phenobarbital codeine, and narcotics including darvocet, percocet and hydrocodone. Drugs known to inhibit or induce enzymes that metabolize alcohol should not be used for 4 weeks prior to the study. These include chlorzoxazone, isoniazid, metronidazole and disulfiram. Cough-and-cold preparations which contain anti-histamines, pain medicines and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib and naproxen, should be withheld for at least 72 hours prior to each study session.
- Self-reported history of flushing upon intake of alcohol.
Exclusion
Key Trial Info
Start Date :
November 16 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 28 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00401999
Start Date
November 16 2006
End Date
January 28 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892