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NCT01967641 · ClinicalTrials.gov registry record · Phase 2
Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT01967641 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 51 participants.
The verdict
NCT01967641, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
In this study, we will assess opioid self-administration in a laboratory setting in persons with pain who have a history of opioid abuse. Participants diagnosed with mild to moderate pain will be admitted to hospital for 7 weeks and transitioned from their baseline prescription opioid to a standing daily dose of Suboxone (buprenorphine/naloxone combination). During this maintenance period, participants will have the opportunity in a laboratory setting to self-administer oxycodone; subjective responses as well as analgesic, physiological and performance effects will be measured. In the second phase of this study, the same patients who participated in the inpatient phase will be followed on an outpatient basis while maintained on Suboxone for 12 weeks. . The hypotheses of this study are that (1) higher progressive ratio break-point values for oxycodone, higher subjective ratings of euphoria, and less pain relief will predict early relapse to opioid abuse; (2) the abuse liability measures will be more strongly correlated with relapse than the pain measures; (3) subjective ratings of euphoria will increase and of pain will decrease in an oxycodone dose-dependent manner (i.e. euphoria will increase and pain will decrease as dose increases); and (4) experimentally induced pain will decrease in an oxycodone dose-dependent manner.
Interventions
- DRUG buprenorphine/naloxone combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2005-11 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01967641
The ClinicalTrials.gov registry entry for NCT01967641 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 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 buprenorphine/naloxone combination is the first listed.
NCT01967641 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01967641 about?
NCT01967641 is a clinical study titled "Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse". In this study, we will assess opioid self-administration in a laboratory setting in persons with pain who have a history of opioid abuse. Participants diagnosed with mild to moderate pain will be admitted to hospital for 7 weeks and transitioned from their baseline prescription opioid to a standing ...
What is the current status of trial NCT01967641?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2005-11. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01967641?
The interventions under investigation include: buprenorphine/naloxone combination (DRUG).
Who is sponsoring clinical trial NCT01967641?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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