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NCT01895270 · ClinicalTrials.gov registry record · Phase 1
Improving Buprenorphine Detoxification Outcomes With Isradipine
A Phase 1 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01895270 is a Phase 1 study that has completed, run by University of Arkansas. The registered enrollment target is 28 participants.
The verdict
NCT01895270, a Phase 1 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This application seeks to address the problem of opioid withdrawal by examining the utility of the L-type calcium channel blocker (CCB) isradipine as an adjunct to BUP detoxification. This project will address the need for improved detoxification strategies by assessing the tolerability and preliminary efficacy of adjunct isradipine during a BUP detoxification in opioid-dependent participants. This pilot clinical trial will determine the potential utility of the L-type CCB isradipine to improve treatment outcomes in up to 60 opioid-dependent individuals undergoing a BUP detoxification procedure. Specifically, this study will determine the efficacy of isradipine to reduce withdrawal symptoms, craving, and illicit use of opioids in opioid-dependent individuals undergoing BUP detoxification and determine the tolerability and safety of controlled-release isradipine (10 mg/day) in opioid-dependent individuals undergoing BUP detoxification. Currently, the only FDA-approved medications for opioid withdrawal are the opioid agonists methadone and BUP, both of which have abuse liability. Our findings, if positive, will support a larger phase II clinical trial.
Interventions
- DRUG Placebo
- DRUG Isradipine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01895270
The ClinicalTrials.gov registry entry for NCT01895270 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01895270 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01895270 about?
NCT01895270 is a clinical study titled "Improving Buprenorphine Detoxification Outcomes With Isradipine". This application seeks to address the problem of opioid withdrawal by examining the utility of the L-type calcium channel blocker (CCB) isradipine as an adjunct to BUP detoxification. This project will address the need for improved detoxification strategies by assessing the tolerability and prelimin...
What is the current status of trial NCT01895270?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2013-10. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01895270?
The interventions under investigation include: Placebo (DRUG), Isradipine (DRUG).
Who is sponsoring clinical trial NCT01895270?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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