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Sponsors and Collaborators: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Eli Lilly and Company |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00310427 |
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. Substance P is released in response to stress and gives rise to behaviors that are thought to represent anxiety. LY686017 blocks Substance P from acting at the NK1 receptors.
People between 21 and 65 years of age who have been drinking on a regular basis for at least one month before entering the study, who meet the criteria for alcohol dependence and who have an elevated score on a general test of anxiety may be eligible for this study.
Participants are admitted to the NIH Clinical Center for 35 days. They participate in an alcohol treatment program in addition to the research study. After having been withdrawn from alcohol for at least 2 days, participants receive either 50 mg of LY686017 or placebo (an inactive substance that looks like the study drug) every morning for 28 days. In addition to drug treatment, they undergo the following procedures:
Condition | Intervention | Phase |
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Alcohol Dependence Alcoholism |
Drug: LY686017 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | NK1 Receptor Antagonism for Treatment of Anxiety and Craving in Anxious Alcohol Dependent Subjects During Early Abstinence |
Estimated Enrollment: | 75 |
Study Start Date: | March 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Study specific exclusion criteria:
Study ID Numbers: | 060129, 06-AA-0129 |
Study First Received: | April 1, 2006 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00310427 History of Changes |
Health Authority: | United States: Federal Government |
Anxiety Alcohol Dependence Alcohol Dependence Alcoholism |
Mental Disorders Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Ethanol |
Mental Disorders Alcoholism Substance-Related Disorders Disorders of Environmental Origin Alcohol-Related Disorders |