Role of Proinflammatory Signaling in Alcohol Craving

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.

Conditions

• Alcohol Dependence
• Alcohol Drinking
• Stress
• Alcohol-Related Disorders

Interventions

DRUG

Pioglitazone

Pioglitazone is a thiazolidinedione antidiabetic. It works by lowering blood sugar by making the cells of the body more sensitive to the action of insulin.

DRUG

Placebo

Placebo is an inactive tablet design to look exactly like pioglitazone

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  lead NIH

Principal Investigators

• Nancy Diazgranados, M.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2015-09-30

Completion

2015-09-30

Countries

• United States

Study Locations