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NCT01136356 · ClinicalTrials.gov registry record · Phase 1
A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01136356: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT01136356 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01136356, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. In addition, some research suggests there is relatively little withdrawal following cessation of chronically administered buprenorphine. This study will examine the spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine in opioid dependent individuals. This study will assess the characteristics and time course of withdrawal using subject-rated and observer-rated measures of opioid withdrawal. Physiologic measures and psychomotor performance will be collected during chronic opioid administration and during placebo administration (i.e., during spontaneous withdrawal). Particular attention will be paid to the differences (if any) in sleep disturbances and withdrawal associated hyperalgesia.
Primary Outcome
Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings.
Interventions
- DRUG morphine
- DRUG buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01136356 record still lists
NCT01136356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which morphine is the first listed.
NCT01136356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01136356 about?
NCT01136356 is a clinical study titled "A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals". Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. In addition, some research su...
What is the current status of trial NCT01136356?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-07. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01136356?
The interventions under investigation include: morphine (DRUG), buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01136356?
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 NCT01136356's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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