Status:
COMPLETED
The Effect of Naltrexone on Alcohol Craving and on Brain Activity During Alcohol Infusion
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Alcoholism
Eligibility:
All Genders
21-50 years
Phase:
EARLY_PHASE1
Brief Summary
This study will determine whether naltrexone, a medicine used to treat alcoholism, can lessen the craving for alcohol during alcohol withdrawal and examine how the drug affects brain activity during a...
Detailed Description
Alcoholism is a chronic, progressive, brain disorder with a profound impact on individuals' lives and economic cost to society. The positive reinforcing effect of alcohol is a key element in the trans...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All participants must:
- be right-handed
- between 21 and 50 years of age
- meet the DSM-IV diagnostic criteria for alcohol dependence (polysubstance abuse is common in younger alcohol-dependent patients, and will not be exclusionary)
- have a positive family history of alcoholism (one or more first-degree relatives with alcohol problems)
- In addition, female participants:
- must have a negative urine pregnancy test (beta-hCG)
- of childbearing capability will be required to use a double contraceptive method (such as oral contraceptives, condom with spermicide or intra-uterine device with spermicide) from the start of the study until at least one month following the last dose of NTX.
- EXCLUSION CRITERIA:
- General exclusion criteria for the NIAAA Intramural treatment program:
- people who present with complicated medical problems requiring intensive medical or diagnostic management, such as uncontrolled hypertension, gastro-intestinal (GI) bleeding, major organ or body system dysfunction or thyroid disease
- people who are infected with human immunodeficiency virus (HIV)
- serious neuro-psychiatric conditions which impair judgment or cognitive function to an extent that precludes them from providing informed consent or complying with study procedures, such as psychotic illness, or severe dementia (individuals not competent to give informed consent)
- people who are unlikely or unable to complete the study because they are likely to be incarcerated while on the protocol
- people who are required to receive treatment by a court of law or who are involuntarily committed to treatment
- Specific exclusion criteria for this protocol include:
- clinically significant hepatobiliary disease
- a history of facial flushing in response to alcohol
- a history of seizures
- currently psychotic
- currently abusing opioids
- use of psychotropic medications (antidepressant, lithium, antipsychotic, anxiolytic, antiepileptic) regularly within the last 4 weeks prior to admission
- having a positive pregnancy test, contemplating pregnancy in the next 3 months, nursing, or not using an effective contraceptive method (if the participant is of child-bearing potential)
- a history of allergy or unusual reactions to NTX
- have received treatment with NTX in the six-month period prior to enrollment
- presence of ferromagnetic brain aneurysm clips, implanted pacemaker, hearing aid, or any other metallic implant, such as pins, screws, plates, dentures, or non-removable jewelry, in or on the body
- pronounced claustrophobia
Exclusion
Key Trial Info
Start Date :
April 22 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00667771
Start Date
April 22 2008
End Date
April 4 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