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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: Clinical Trial Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Interventions
- DRUG Placebo
- DRUG Pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
Why NCT01631630 stopped before completion
NCT01631630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01631630 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01631630's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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