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NCT01517165 · ClinicalTrials.gov registry record · Phase 1
Pioglitazone to Treat Opioid Withdrawal Symptoms
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01517165: Clinical Trial Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT01517165 is a Phase 1 study that was terminated before completion, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01517165, a Phase 1 study, was terminated before completion, sponsored by National Institute on Drug Abuse (NIDA).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Background: * Opioid-withdrawal symptoms include runny nose, body aches, chills, sweating, and diarrhea. Many people have these symptoms when trying to stop using opioid drugs. Long-acting opioids like methadone and buprenorphine are used to help people stop using other opioids, but these drugs can cause the same withdrawal symptoms. There are no non-opioid drugs that are approved specifically to treat those symptoms. * Pioglitazone is a drug used to treat type 2 diabetes. In a research study, the drug allowed heroin users to decrease their methadone dose faster without much discomfort, and stay abstinent from heroin. Researchers want to learn more about how pioglitazone helps treat opioid withdrawal symptoms. Objectives: \- To test whether pioglitazone can reduce opioid withdrawal symptoms. Eligibility: \- Individuals between 18 and 65 years of age who will be using buprenorphine to treat opioid dependency. Design: * This study will last up to 17 weeks. Participants must come to the study clinic every day for at least 13 weeks. * Participants will be screened with a physical exam and medical history. They will also answer questions about drug use habits, and provide blood and urine samples. * Participants will take buprenorphine daily for 7 weeks. For the first 3 weeks, the dose will be increased to a level that should help stop the use of opioids. For the next 4 weeks, the dose will be decreased. Blood, urine, and breath samples will be collected at different study visits. Participants will also fill out questionnaires about mood, drug craving, and withdrawal symptoms. * After 1 week on buprenorphine, participants will start the study pill (pioglitazone or a placebo) every day. They will take the study pill for 13 weeks. * During the treatment period, participants will have drug counseling once a week for 30 minutes. * Some participants have other tests as part of this study. These tests include functional magnetic resonance imaging scans to look for change
Interventions
- DRUG Placebo
- DRUG Pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-01-04 |
| Est. Completion | 2015-02-02 |
| Phase | Phase 1 |
Why NCT01517165 stopped before completion
NCT01517165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01517165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01517165 about?
NCT01517165 is a clinical study titled "Pioglitazone to Treat Opioid Withdrawal Symptoms". Background: * Opioid-withdrawal symptoms include runny nose, body aches, chills, sweating, and diarrhea. Many people have these symptoms when trying to stop using opioid drugs. Long-acting opioids like methadone and buprenorphine are used to help people stop using other opioids, but these drugs can...
What is the current status of trial NCT01517165?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-01-04. Estimated completion is 2015-02-02.
What interventions are being tested in trial NCT01517165?
The interventions under investigation include: Placebo (DRUG), Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT01517165?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01517165's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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