NCT00723697 (OPUS R) is a clinical trial of buprenorphine in Buprenorphine, sponsored by Indivior Inc..

Who is sponsoring NCT00723697?

NCT00723697 is sponsored by Indivior Inc..

What drugs are being tested in NCT00723697?

Interventions in NCT00723697: buprenorphine.

What condition does NCT00723697 study?

NCT00723697 studies Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence, Drug Abuse.

Is NCT00723697 still recruiting?

NCT00723697 is currently completed. Last updated 16 March 2023.

Are results published for NCT00723697?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-16 · How we verify

NCT00723697: OPUS R

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Etude Observationnelle Prospective de l'Utilisation en Situation Reelle; Prospective Real Situation Observational Study of Subutex® or Its Buprenorphine High Dose Generic (BHD) in the Replacement Treatment of Major Opiate Dependence: Following Parameters With Respect to Misuse and Pharmacovigilance

Completed Results posted Last updated 16 March 2023

What this trial tests

trial testing buprenorphine in Buprenorphine in 1,307 participants. Completed in 1 February 2010.

Timeline

1 May 2007

Primary endpoint
1 February 2010

1 February 2010

Quick facts

Lead sponsor	Indivior Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,307
Start date	1 May 2007
Primary completion	1 February 2010
Estimated completion	1 February 2010

Drugs / interventions tested

buprenorphine (BUPRENORPHINE) — full drug profile →

Conditions studied

Buprenorphine — all drugs for Buprenorphine →
Naloxone — all drugs for Naloxone →
Opiate-related Disorders — all drugs for Opiate-related Disorders →
Opiate Dependence — all drugs for Opiate Dependence →

Sponsor

Indivior Inc. — full company profile →

Who can join

Eligibility, any sex, with Buprenorphine or Naloxone. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)
Time frame: first visit, 6 months, and 12 months
Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.
Time frame: first visit, 6 months, and 12 months
Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.

Sponsor's own description

The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this study. Data will be collected using physician questionnaires and self evaluation patient questionnaires at the first visit and visits at 6 and 12 months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of buprenorphine

Trials testing the same drug.

NCT04212065 — Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women · Phase 4 · withdrawn
NCT03492099 — Assessing the Safety of Buprenorphine in People With Sickle Cell Disease · Phase 2 · completed
NCT02181231 — Buprenorphine Used With Treatment Resistant Depression in Older Adults · Phase 1, PHASE2 · completed
NCT03583138 — HIV, Buprenorphine, and the Criminal Justice System (STRIDE2) · completed

Other recruiting trials for Buprenorphine

Currently open trials in the same condition.

NCT07158853 — Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder · NA · recruiting
NCT06742554 — Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthrosc · Phase 4 · active not recruiting
NCT05505227 — Developing a Tailored Stigma Reduction Intervention to Increase Buprenorphine Prescribing · NA · active not recruiting

Other Indivior Inc. trials

Trials by the same sponsor.

NCT06576843 — INDV-6001 Multiple-Dose Pharmacokinetic Study · Phase 2 · completed
NCT06384157 — Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder · Phase 2 · completed
NCT05878210 — Evaluating the SUBLOCADE Treatment Exit Strategy · completed
NCT05860959 — SUBLOCADE Long-term Outcomes · completed
NCT05974046 — Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00723697 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indivior Inc.
Last refreshed: 16 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00723697.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing