Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01631630 · ClinicalTrials.gov registry record · Phase 2
Role of Proinflammatory Signaling in Alcohol Craving
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01631630 is a Phase 2 study that was terminated before completion, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 16 participants.
The verdict
NCT01631630, a Phase 2 study, was terminated before completion, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01631630
The ClinicalTrials.gov registry entry for NCT01631630 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01631630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01631630 about?
NCT01631630 is a clinical study titled "Role of Proinflammatory Signaling in Alcohol Craving". 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,...
What is the current status of trial NCT01631630?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2012-05. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01631630?
The interventions under investigation include: Placebo (DRUG), Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT01631630?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.