Role of Proinflammatory Signaling in Alcohol Craving
Status:
Terminated
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
Background:
- Drinking too much alcohol can injure cells in the body. Inflammation is the body s reaction
to injured cells. Studies show that inflammation can cause cravings for alcohol. Researchers
want to see if pioglitazone, a drug that decreases inflammation, can reduce alcohol craving.
If so, it might help develop new ways to help alcoholics with craving.
Objectives:
- To see if pioglitazone can reduce alcohol craving.
Eligibility:
- Adults between 21 and 65 years of age who are alcoholic and have been drinking within the
past month.
Design:
- Participants will be screened with a physical exam and medical history. Blood samples
will also be collected.
- All participants will have inpatient treatment at the National Institutes of Health
Clinical Center for the 5 weeks of the study. They will have standard treatment for
alcoholism during their inpatient stay.
- Half of the people in this study will have pioglitazone. The other half will have a
placebo.
- Participants will have different studies during their stay. These studies will include
the following:
- Personalized audio recordings of stressful, alcohol-related, and neutral events to
monitor mood
- Imaging studies to test alcohol cravings
- Questionnaires about mood and alcohol cravings
- Lumbar puncture to collect spinal fluid
- Inflammation test to see if the study drug can block alcohol cravings
- After the end of the 5-week study, all participants will be offered follow-up outpatient
care through the Clinical Center, or referral to outside treatment.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)