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NCT01642030 · ClinicalTrials.gov registry record · Phase 1
Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorphine Maintenance
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
NCT01642030: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT01642030 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 132 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01642030, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
Study Summary
Pain is very common in persons with a history of addiction, but few studies have examined the best treatment of pain in this population. This is a study to determine the pain relief provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons maintained on stable doses of methadone or buprenorphine. Experimental sessions will require overnight stays on a residential research unit. In these sessions, persons will be exposed to standard experimental pain techniques at baseline and then rate the relief (if any) provided by the study medication when exposed to the same techniques. Persons will be asked to participate in 2 or 3 sessions, each separated by at least 7 days.
Primary Outcome
The participant places a hand up to the wrist in a circulating water bath maintained at approximately 4 degrees Celsius (up to 5 minutes). The time at which pain develops is the threshold. The time a volunteer's hand remains underwater before pain is unbearable is tolerance.
Interventions
- DRUG Placebo
- DRUG Hydromorphone
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-07 |
| Phase | Phase 1 |
What the finished NCT01642030 record still lists
NCT01642030 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01642030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01642030 about?
NCT01642030 is a clinical study titled "Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorphine Maintenance". Pain is very common in persons with a history of addiction, but few studies have examined the best treatment of pain in this population. This is a study to determine the pain relief provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons maintained on stable doses of metha...
What is the current status of trial NCT01642030?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2013-08. Estimated completion is 2017-07.
What interventions are being tested in trial NCT01642030?
The interventions under investigation include: Placebo (DRUG), Hydromorphone (DRUG), Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01642030?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01642030's enrollment target sits among peer trials
132 432nd of 2000 higher than 1,562 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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