Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00007527 · ClinicalTrials.gov registry record · Phase 4
Determine the Safety of a Sublingual Tablet Formulation of Buprenorphine and Naloxone by Extending the Combination Tablet Availability to Physicians in Office-Based Practice
A Phase 4 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 4
- Development phase
- 600
- Enrollment target
NCT00007527: Completed Phase 4 study, sponsored by US Department of Veterans Affairs.
NCT00007527 is a Phase 4 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 600 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00007527, a Phase 4 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 600 participants
- Enrollment target
Study Summary
The CS 1018 study will recruit a total of 600 patients seeking treatment for opiate dependence. They will be recruited from six states (Florida, New York, Texas, California, Washington, and Illinois), with up to ten private physician sites or clinics participating in each state. Coordination of the participating sites and clinics in each of the six states will be performed from an associated Department of Veterans Affairs Medical Center (Tampa VAMC, New York City VAMC, San Antonio VAMC, Long Beach VAMC, Seattle VAMC, and Hines VAMC). The Principal Investigator (PI) at each of the six VAMC?s will be a physician experienced in the treatment of opiate dependent patients. Patients will be recruited by any of numerous strategies including word of mouth, self-referral, local fliers, newspapers, and radio advertisements. This study will be conducted open label with no random assignment or stratification. Patients may be accepted for detoxification or longer-term treatment (6 to 12 months of buprenorphine/naloxone therapy). Patients under the age of 21 will initially be admitted for detoxification; longer treatment of these patients will be based on physician judgement of the necessary of continued treatment. Patients will be inducted directly into buprenorphine/naloxone 4:1 combination tablets. Patients treated in private practice will be asked to sign a treatment contract which will delineate the terms and conditions of treatment.
Interventions
- DRUG naloxone
- DRUG buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 1999-08 |
| Est. Completion | 2002-01 |
| Phase | Phase 4 |
What the finished NCT00007527 record still lists
NCT00007527 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 2 interventions - of which naloxone is the first listed.
NCT00007527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00007527 about?
NCT00007527 is a clinical study titled "Determine the Safety of a Sublingual Tablet Formulation of Buprenorphine and Naloxone by Extending the Combination Tablet Availability to Physicians in Office-Based Practice". The CS 1018 study will recruit a total of 600 patients seeking treatment for opiate dependence. They will be recruited from six states (Florida, New York, Texas, California, Washington, and Illinois), with up to ten private physician sites or clinics participating in each state. Coordination of the ...
What is the current status of trial NCT00007527?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 600 participants. The study started on 1999-08. Estimated completion is 2002-01.
What interventions are being tested in trial NCT00007527?
The interventions under investigation include: naloxone (DRUG), buprenorphine (DRUG).
Who is sponsoring clinical trial NCT00007527?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00007527's enrollment target sits among peer trials
600 137th of 2000 higher than 1,854 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00004317 · 600 participants · Phase 4
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
- NCT00209235 · 600 participants · NA
Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments
- NCT01473784 · 600 participants · NA
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
- NCT01866371 · 600 participants
High Resolution Retinal Imaging
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia