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NCT03415581 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Doxazosin to Alter the Abuse of Oxycodone
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT03415581 is a Phase 2 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 13 participants.
The verdict
NCT03415581, a Phase 2 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
Healthy, adult men and women, aged 21 to 59 years, who abuse opioids and are physically dependent on them will be recruited to participate in a study to examine the ability of doxazosin, an epinephrine receptor blocker, to alter the abuse potential of oxycodone. After participants complete the screening process, they will be scheduled for inpatient admission onto our clinical inpatient where they will reside during the 8-week study. During Weeks 1-2, participants will be transitioned from their normal opioid use regime onto oral morphine until withdrawal dissipates. At this time participants will also be stabilized on the first dose of doxazosin (0 or 16 mg/day; active doxazosin will be started at 4 mg and increased by 4 mg every 3 days). During Weeks 3-4, either active or placebo oxycodone will be available (in random order). Monday-Friday each these drugs will be tested using our sample and choice self-administration procedure. On Friday, participants will also complete a cue exposure session during which they will be presented drug cues to determine whether the study medication affects how participants react to them. To summarize, Weeks 1-2 and 5-6 will be stabilization weeks (0 or 16 mg doses of doxazosin administered in random order) and Weeks 3-4 and 7-8 will be test weeks under each of the doxazosin maintenance doses. At the conclusion of the study, participants will be given an exit interview, warnings about re-initiation of opioid use, and counseling about the different treatment options for Opioid Use Disorder. Within 1 week after discharge, investigators will assess adverse events using the a number of clinical assessments. At each weekly visits, investigators will assess participants' interest in treatment and drug use patterns.
Interventions
- DRUG Intranasal Oxycodone
- BEHAVIORAL Cue Session
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-02-12 |
| Est. Completion | 2019-12-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03415581
The ClinicalTrials.gov registry entry for NCT03415581 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intranasal Oxycodone is the first listed.
NCT03415581 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03415581 about?
NCT03415581 is a clinical study titled "Evaluation of Doxazosin to Alter the Abuse of Oxycodone". Healthy, adult men and women, aged 21 to 59 years, who abuse opioids and are physically dependent on them will be recruited to participate in a study to examine the ability of doxazosin, an epinephrine receptor blocker, to alter the abuse potential of oxycodone. After participants complete the scree...
What is the current status of trial NCT03415581?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2017-02-12. Estimated completion is 2019-12-23.
What interventions are being tested in trial NCT03415581?
The interventions under investigation include: Intranasal Oxycodone (DRUG), Cue Session (BEHAVIORAL).
Who is sponsoring clinical trial NCT03415581?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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