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NCT00637000 · ClinicalTrials.gov registry record · Phase 2
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
A Phase 2 study of Opioid-Related Disorders, sponsored by Indivior.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT00637000: Completed Phase 2 study of Opioid-Related Disorders, sponsored by Indivior.
NCT00637000 is a Phase 2 study of Opioid-Related Disorders that has completed, run by Indivior. The registered enrollment target is 38 participants, below the 346-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00637000, a Phase 2 study of Opioid-Related Disorders, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.
Primary Outcome
The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 3
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Buprenorphine soluble film
- DRUG Buprenorphine/naloxone film strip
Study Locations (1)
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2008-03 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
What the finished NCT00637000 record still lists
NCT00637000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 346-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Opioid-Related Disorders appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00637000 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00637000 about?
NCT00637000 is a clinical study titled "Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone". The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of with...
What is the current status of trial NCT00637000?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2008-03. Estimated completion is 2008-09.
What conditions does trial NCT00637000 study?
This clinical trial studies the following conditions: Opioid-Related Disorders.
What interventions are being tested in trial NCT00637000?
The interventions under investigation include: Placebo (DRUG), Buprenorphine soluble film (DRUG), Buprenorphine/naloxone film strip (DRUG).
Who is sponsoring clinical trial NCT00637000?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00637000 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 NCT00637000's enrollment target sits among peer trials
38 36th of 47 higher than 12 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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