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NCT03860753 · ClinicalTrials.gov registry record · Phase 1
Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)
A Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT03860753: Clinical Trial Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
NCT03860753 is a Phase 1 study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03860753, a Phase 1 study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of pioglitazone on stress- and alcohol-related measures in treatment-seeking individuals with alcohol use disorder (AUD) and elevated levels of stress and anxiety.
Primary Outcome
The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and heart rate will be measured before and after CPT. The heart rate change for each time point is calculated as heart rate after CPT minus the heart rate before CPT. This outcome measure reports the heart rate change at
Interventions
- DRUG Placebo
- DRUG Pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2019-08-23 |
| Phase | Phase 1 |
Why NCT03860753 stopped before completion
NCT03860753 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03860753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03860753 about?
NCT03860753 is a clinical study titled "Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)". The purpose of this study is to assess the effect of pioglitazone on stress- and alcohol-related measures in treatment-seeking individuals with alcohol use disorder (AUD) and elevated levels of stress and anxiety.
What is the current status of trial NCT03860753?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2019-03-01. Estimated completion is 2019-08-23.
What interventions are being tested in trial NCT03860753?
The interventions under investigation include: Placebo (DRUG), Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT03860753?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03860753's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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