The Effect of Naltrexone on Alcohol Craving and on Brain Activity During Alcohol Infusion
Status:
Completed
Trial end date:
2011-04-04
Target enrollment:
Participant gender:
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 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:
Screening
- 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
Days 1-7
- 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.
Follow-up
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.
...
Phase:
Early Phase 1
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)