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NCT01895036 · ClinicalTrials.gov registry record · Phase 1
Nalrexone Facilitated Discontinuation of Buprenorphine
A Phase 1 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01895036 is a Phase 1 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 6 participants.
The verdict
NCT01895036, a Phase 1 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The efficacy of buprenorphine as a long-term agonist treatment has been offset by the emergence of intolerable withdrawal phenomena in a subset of individuals on chronic maintenance who attempt to discontinue the medication. Efforts are needed to better understand these challenges encountered with buprenorphine, as well as to develop interventions to facilitate medication discontinuation. Emerging evidence suggests that these difficulties may be related to the unique effects of buprenorphine on sites other than mu-opioid receptors, such as kappa-opioid receptors. Kappa-opioid agonism produces aversive, dysphoric-like effects, and can also increase the likelihood of reinstatement to drug use through stress-mediated mechanisms. Some of the discomfort observed during drug taper may therefore be due to the attenuation or loss of kappa-opioid antagonism afforded by buprenorphine, as well as to rebound kappa-opioid activation. Naltrexone represents a promising candidate for extending kappa blockade and therefore for facilitating discontinuation attempts. Naltrexone and its active metabolite 6-Beta-naltrexol are competitive antagonists at the mu and kappa receptors, and to a lesser extent at the delta receptor. Naltrexone and buprenorphine have comparable affinity for the mu-opioid receptor and thus buprenorphine is displaced by naltrexone more gradually than are other opioids with less affinity; a careful titration of naltrexone is less likely, therefore, to precipitate severe withdrawal states in individuals coming off buprenorphine, and the two have been combined to good effect in other settings. The purpose of this study is therefore to investigate the feasibility of naltrexone augmentation on discontinuing buprenorphine in eligible patients on long-term maintenance.
Interventions
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01895036
The ClinicalTrials.gov registry entry for NCT01895036 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 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 1 intervention - of which Naltrexone is the first listed.
NCT01895036 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01895036 about?
NCT01895036 is a clinical study titled "Nalrexone Facilitated Discontinuation of Buprenorphine". The efficacy of buprenorphine as a long-term agonist treatment has been offset by the emergence of intolerable withdrawal phenomena in a subset of individuals on chronic maintenance who attempt to discontinue the medication. Efforts are needed to better understand these challenges encountered with b...
What is the current status of trial NCT01895036?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-02. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01895036?
The interventions under investigation include: Naltrexone (DRUG).
Who is sponsoring clinical trial NCT01895036?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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