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NCT01210079 · ClinicalTrials.gov registry record · Phase 2
Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?
A Phase 2 study of Opioid-Induced Hyperalgesia, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT01210079: Completed Phase 2 study of Opioid-Induced Hyperalgesia, sponsored by University of California, Los Angeles.
NCT01210079 is a Phase 2 study of Opioid-Induced Hyperalgesia that has completed, run by University of California, Los Angeles. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01210079, a Phase 2 study of Opioid-Induced Hyperalgesia, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients. Specifically, in a sample of MM patients, gabapentin, which has proven efficacy in treating neuropathic pain will be evaluated for its ability to ameliorate or diminish the opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and tolerance to both cold-pressor and electrical pain, at peak and through methadone blood levels. The results of this work will not only provide pharmacologic insight into the mechanisms underlying poor pain tolerance in this at-risk population, but also direction for the medical management of pain complicated by opioid-induced hyperalgesia.
Primary Outcome
Change in pain threshold time from baseline (pre-gabapentin) to week 5 (post gabapentin)measured during cold pressor task administered at peak methadone blood levels. Pain threshold time is the amount of time that passes before pain is detected after administration of the cold pressor.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Gabapentin;
Study Locations (1)
California
- UCLA School of Nursing - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2002-09 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
What the finished NCT01210079 record still lists
NCT01210079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Opioid-Induced Hyperalgesia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01210079 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01210079 about?
NCT01210079 is a clinical study titled "Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?". Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients. Specifically, in a sample of MM...
What is the current status of trial NCT01210079?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2002-09. Estimated completion is 2010-05.
What conditions does trial NCT01210079 study?
This clinical trial studies the following conditions: Opioid-Induced Hyperalgesia.
What interventions are being tested in trial NCT01210079?
The interventions under investigation include: Placebo (DRUG), Gabapentin; (DRUG).
Who is sponsoring clinical trial NCT01210079?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01210079 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01210079's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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