NCT01666119 is a Phase 2 clinical trial of BEMA Buprenorphine NX films in Opioid Dependence, sponsored by BioDelivery Sciences International.

Who is sponsoring NCT01666119?

NCT01666119 is sponsored by BioDelivery Sciences International.

What drugs are being tested in NCT01666119?

Interventions in NCT01666119: BEMA Buprenorphine NX films.

What condition does NCT01666119 study?

NCT01666119 studies Opioid Dependence.

Is NCT01666119 still recruiting?

NCT01666119 is currently completed. Last updated 13 February 2017.

Are results published for NCT01666119?

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

Last reviewed 2017-02-13 · How we verify

NCT01666119

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

An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects (BNX-201)

Completed Phase 2 Results posted Last updated 13 February 2017

What this trial tests

Phase 2 trial testing BEMA Buprenorphine NX films in Opioid Dependence in 249 participants. Completed in 1 January 2013.

Timeline

1 August 2012

Primary endpoint
1 January 2013

1 January 2013

Quick facts

Lead sponsor	BioDelivery Sciences International
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	249
Start date	1 August 2012
Primary completion	1 January 2013
Estimated completion	1 January 2013
Sites	10 locations across United States

Drugs / interventions tested

BEMA Buprenorphine NX films — full drug profile →

Conditions studied

Opioid Dependence — all drugs for Opioid Dependence →

Sponsor

BioDelivery Sciences International — full company profile →

Who can join

Adults 18 to 65, any sex, with Opioid Dependence. 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.

Adverse Events
Time frame: 12 weeks
Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in \> 2 subjects, the total number of unique events that were experienced are reported.

Sponsor's own description

This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized on Suboxone (buprenorphine/naloxone) tablets or films. Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX. This dose will be taken throughout the 12-week treatment period with dose adjustments as clinically indicated for either the control of opioid dependence or adverse events (AEs).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Orodispersible Films: Current Innovations and Emerging Trends.
Jacob S, Boddu SHS, Bhandare R, Ahmad SS, et al · · 2023 · cited 21× · PMID 38140094 · DOI 10.3390/pharmaceutics15122753
Novel Buccal Film Formulation of Buprenorphine-Naloxone for the Maintenance Treatment of Opioid Dependence: A 12-Week Conversion Study.
Sullivan JG, Webster L. · · 2015 · cited 16× · PMID 25823919 · DOI 10.1016/j.clinthera.2015.02.027

Verify or expand the search:

Other recruiting trials for Opioid Dependence

Currently open trials in the same condition.

NCT05585229 — Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication · Phase 2 · recruiting
NCT06574009 — Better Options for Chronic Cancer Pain · Phase 4 · recruiting
NCT06837662 — The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Dis · NA · recruiting
NCT05620940 — A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subj · Phase 1 · recruiting
NCT05603702 — STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis · Phase 1 · recruiting

Other BioDelivery Sciences International trials

Trials by the same sponsor.

NCT03996694 — Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo. · Phase 1 · completed
NCT03720613 — Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation · recruiting
NCT02516436 — The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects · Phase 3 · withdrawn
NCT01713803 — Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects · Phase 3 · withdrawn

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 NCT01666119 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioDelivery Sciences International
Last refreshed: 13 February 2017

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/NCT01666119.

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