The Effect of Naltrexone on Alcohol Craving and on Brain Activity During Alcohol Infusion
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|ClinicalTrials.gov Identifier: NCT00667771|
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : July 2, 2017
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 alcohol infusion.
People between 21 and 50 years of age who are right-handed, alcohol-dependent, and have at least one family member with a history of alcoholism, may be eligible for this study.
Participants are admitted to the NIH Clinical Center for 1 month for the following procedures:
- Medical history, alcohol-use history and family history of alcoholism
- Physical examination, psychological tests and blood tests
- Medicine to lessen alcohol withdrawal symptoms, if necessary
- Alcohol detoxification
- Medical and psychological evaluations
- Assignment to naltrexone or placebo group
Days 7 through 28
- Drug treatment: Take naltrexone or placebo capsule every morning
- Additional alcohol-dependence treatment: Cognitive and behavioral therapies and participation in self-help groups, such as Alcoholics Anonymous
- Weekly questionnaires to measure mood and desire for alcohol
- Blood tests
- Alcohol craving stimulation test (day 7): Subjects handle and sniff water and then their favorite alcoholic beverage. They then rate their urge to drink alcohol and their level of anxiety and their heart rate is measured.
- Alcohol infusion test (day 9): Subjects have an MRI scan during infusion through a vein of saline (salt water), followed by infusion of alcohol. For this test, a catheter (plastic tube) is placed in a vein in each arm, one for administering the saline and then alcohol; the other for drawing blood samples to measure blood alcohol level and body chemistries. Before, during and after the infusion, subjects are asked to respond to questions about their feelings, cravings and mood changes.
Subjects are asked to participate in a 3-month outpatient assessment program involving five outpatient visits (at 1, 2, 4, 8 and 12 weeks after discharge). At each visit, they fill out questionnaires and to take a breathalyzer test and blood and urine tests for drugs. They may continue naltrexone therapy and weekly group therapy sessions during this time. Subjects who do not participate in the assessment program are contacted at home by phone once a week for 1 month and then every other week for the next 2 months to monitor alcohol abstinence.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence Alcoholism||Drug: Naltrexone||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Naltrexone on Craving and Ethanol-Induced Brain Activity|
|Study Start Date :||April 22, 2008|
|Actual Primary Completion Date :||December 27, 2010|
|Actual Study Completion Date :||April 4, 2011|
- BOLD response during the ethanol infusion challenge
- Self-reported AUQ, PACS, OCDS, POMS and cue-induced craving during the CR session
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667771
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|