Role of Proinflammatory Signaling in Alcohol Craving
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Alcohol Dependence, Alcohol Drinking, Stress, Alcohol-Related Disorders
In brief
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.
Key facts
- Study ID
- NCT01631630
- Run by
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- People needed
- 16
- Starts
- 2012-05-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2017-03-09
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Any medical illness that in the view of the investigators would compromise participation in research, as determined by medical history, physical examination, laboratory tests (see details under Screening measures below), including, but not limited to:
- Diabetes mellitus Type I or Type II
- Past or current diagnosis of congestive heart failure
- Signs and symptoms suggestive of congestive heart failure
- Cardiovascular disease (e.g., history of congenital heart defect, heart disease, symptomatic coronary-artery disease, heart attack, clinically significant arrhythmia, etc.)
- Cerebrovascular disease
- Infection, autoimmune disease, or fever of unknown origin
- Unexplained history of syncope
- History of seizures, except for febrile seizures during childhood
- History of head injury with loss of consciousness of more than 30 minutes or with postconcussive sequelae lasting more than two days, regardless of loss of consciousness
- Chronic renal failure as estimated by glomerular filtration rate (GFR) <60 milliliters per minute 1.73 per Square
- HIV infection
- Active bladder cancer, history of bladder cancer, or persistent hematuria
- Allergy, hypersensitivity, or intolerance to pioglitazone, other thiazolidinediones, or the metabolites of any of those drugs (determined by medical history)
- Pregnancy or breastfeeding (urine pregnancy test; self-report)
- Diabetes medications (e.g., sulfonylureas, metformin, insulin, etc.)
- Contraindicated or strongly interacting medications: Gemfibrozil (inhibitor of CYP2C8) and rifampin (inducer of CYP2C8), atorvastatin, ketoconazole, nifedipine
- Any ongoing, or regular use of central nervous system (CNS) active medications within the last week (fluoxetine: last 4 weeks), with the exception of withdrawal medication, obtained according to the NIAAA clinical guidelines if needed
- Use of docosahexaenoic acid (DHA) dietary supplements, or consumption of oily fish >3 times per week (because of effects of DHA on inflammatory parameters)
- History of Rhabdomyolysis
- Psychiatric history:
- Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires, as established by clinical exam, in questionable cases aided by a Mini Mental State Examination (with a score of <21, indicating more than mild cognitive impairment, being exclusionary)
- Current diagnosis of schizophrenia or any other DSM-IV psychotic disorder, bipolar disorder, or major depressive disorder, in each case as established by clinical evaluation and SCID.
- Substance use disorders:
- Current alcohol intoxication on breathalyzer test or positive urine drug screen on enrollment
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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