Status:
COMPLETED
Effect of LY686017 on Alcohol Craving
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Alcohol Dependence
Alcoholism
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
This study will determine whether the experimental drug LY686017 can reduce a person's desire for alcohol. A brain chemical called Substance P acts at places in the brain called NK1 receptors. Substan...
Detailed Description
Background: Alcoholism is a chronic relapsing disorder characterized by cycles of intoxication interspersed with phases of withdrawal and abstinence. Co-morbidity with depression and anxiety disorder...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 21 - 65.
- DSM-IV diagnosis of alcohol dependence on SCID, alcohol problems as primary complaint among substance use disorder, and alcohol use within the last month.
- Spielberger trait anxiety score greater than 39.
- Females of childbearing potential must agree to use a reliable method of birth control during the study. Reliable methods of birth control include oral contraceptives or Norplant(Registered Trademark); barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices; a partner with a vasectomy; or abstinence from intercourse.
- EXCLUSION CRITERIA:
- Subjects will be excluded if they meet any of the criteria below. The criteria for enrollment will be followed explicitly. If a subject who does not meet enrollment criteria is inadvertently enrolled, that subject will be discontinued from the study and Eli Lilly will be contacted.
- General exclusion criteria for the NIAAA intramural treatment program:
- People who present with complicated medical problems requiring intensive medical or diagnostic management, such as hypertensive emergency, serious GI bleeding, major organ or body system dysfunction such as decompensated liver disease, renal failure, myocardial ischemia, congestive heart failure or cerebrovascular disease, major endocrine problems such as uncontrolled diabetes, pancreatic or thyroid disease.
- People who are infected with the 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 treatment, such as psychotic illness or severe dementia (incompetent individuals).
- People who are unlikely or unable to complete the treatment program because they become or 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.
- People with uncontrolled hypertension
- Study specific exclusion criteria:
- People who are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- People who are employees of Eli Lilly \& Co.
- Treatment within the last 30 days with a drug \[not including study drug\] that has not received regulatory approval for any indication at the time of study entry.
- A history of seizures, other than documented febrile seizures
- Patients with clinically significant hepatobiliary disease (as evaluated by a trained hepatologist) will be excluded from the protocol
- Pregnancy or lactation (negative pregnancy test required)
- Regular use of psychotropic medication (antidepressant, lithium, antipsychotic, anxiolytic, antiepileptic) within last 4 weeks, with the exception of benzodiazepines administered within the NIAAA program as part of alcohol withdrawal treatment.
- Inability or unwillingness to participate in an fMRI scan, including presence of metallic objects in the body, or pronounced claustrophobia
- Hypopituitarism or reduced adrenal secretory activity because of the risk of precipitating acute adrenal failure with metyrapone.
- Porphyria because metyrapone may be porphyrinogenic based on data from in-vitro systems.
- Thyroid dysfunction, which may alter the response to metyrapone.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00310427
Start Date
March 1 2006
End Date
March 1 2008
Last Update
April 20 2010
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892