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NCT01188421 · ClinicalTrials.gov registry record · Phase 1
Medications Development for Drug Abuse Disorders
A Phase 1 study of Opioid-Related Disorders and Opioid Dependence, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
- 1
- Study location
NCT01188421: Completed Phase 1 study of Opioid-Related Disorders and Opioid Dependence, sponsored by Johns Hopkins University.
NCT01188421 is a Phase 1 study of Opioid-Related Disorders and Opioid Dependence that has completed, run by Johns Hopkins University. The registered enrollment target is 106 participants, below the 345-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01188421, a Phase 1 study of Opioid-Related Disorders and Opioid Dependence, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants will be treated on a residential unit. The primary outcome measure is opioid withdrawal symptoms.
Primary Outcome
Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is
Conditions Studied
Interventions
- DRUG Buprenorphine/naloxone
- DRUG Clonidine
- DRUG Tramadol ER
Study Locations (1)
Maryland
- Johns Hopkins University (BPRU) Bayview Campus - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2010-10 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT01188421 record still lists
NCT01188421 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 345-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (69% lower).
The record links to 3 conditions, with Opioid-Related Disorders appearing as the primary indexed condition, and to 3 interventions - of which Buprenorphine/naloxone is the first listed.
NCT01188421 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01188421 about?
NCT01188421 is a clinical study titled "Medications Development for Drug Abuse Disorders". This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants...
What is the current status of trial NCT01188421?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2010-10. Estimated completion is 2015-06.
What conditions does trial NCT01188421 study?
This clinical trial studies the following conditions: Opioid-Related Disorders, Opioid Dependence, Opioid Addiction.
What interventions are being tested in trial NCT01188421?
The interventions under investigation include: Buprenorphine/naloxone (DRUG), Clonidine (DRUG), Tramadol ER (DRUG).
Who is sponsoring clinical trial NCT01188421?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01188421 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid-Related Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01188421's enrollment target sits among peer trials
106 26th of 47 higher than 22 of 47 other Opioid-Related Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid-Related Disorders 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.
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