NCT02294253 is a Phase 2/Phase 3 clinical trial of Buprenorphine/naloxone in Opioid Dependence, sponsored by New York State Psychiatric Institute.

Who is sponsoring NCT02294253?

NCT02294253 is sponsored by New York State Psychiatric Institute.

What drugs are being tested in NCT02294253?

Interventions in NCT02294253: Buprenorphine/naloxone.

What condition does NCT02294253 study?

NCT02294253 studies Opioid Dependence.

Is NCT02294253 still recruiting?

NCT02294253 is currently completed. Last updated 6 March 2020.

Are results published for NCT02294253?

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

Last reviewed 2020-03-06 · How we verify

NCT02294253

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

Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone: An Outpatient Detoxification for Opioid Dependence.

Completed Phase 2/Phase 3 Results posted Last updated 6 March 2020

What this trial tests

Phase 2/Phase 3 trial testing Buprenorphine/naloxone in Opioid Dependence in 30 participants. Completed in 1 December 2017.

Timeline

1 September 2014

Primary endpoint
1 December 2017

1 December 2017

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 September 2014
Primary completion	1 December 2017
Estimated completion	1 December 2017
Sites	1 location across United States

Drugs / interventions tested

Buprenorphine/naloxone

Conditions studied

Opioid Dependence — all drugs for Opioid Dependence →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 18 to 60, any sex, with Opioid Dependence. Healthy volunteers can join.

What's being measured

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

Successful Induction Onto XR-NTX
Time frame: One week after completing 30-day buprenorphone/naloxone stabilization/taper.
Proportion of participants inducted onto XR-NTX at the end of the 30-day buprenorphine/naloxone stabilization/taper.

Sponsor's own description

The investigators will randomize 50 opioid-dependent participants who have initially failed outpatient induction onto XR-NTX; participants will receive buprenorphine/naloxone on a weekly basis for 30 days. Buprenorphine/naloxone will be dispensed weekly during the 30-day stabilization and twice weekly during taper phase, and all patients who successfully complete the detoxification will be offered induction onto XR-NTX. All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication. The primary outcome of this study will be percentage of patients successfully inducted onto XR-NTX. Secondary outcomes will be time to relapse, defined as opioid use or dropout.

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/naloxone

Trials testing the same drug.

NCT05011266 — Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder · Phase 2, PHASE3 · recruiting
NCT04480554 — Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1 · Phase 2 · terminated
NCT05307458 — Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing · unknown
NCT04794790 — Buprenorphine Induction for Fentanyl Dependent Opioid Users · EARLY_PHASE1 · withdrawn
NCT03580902 — CBT4CBT for Office Based Buprenorphine · Phase 1, PHASE2 · completed

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 New York State Psychiatric Institute trials

Trials by the same sponsor.

NCT05416658 — Shared Decision Making for Antipsychotic Medications · NA · not yet recruiting
NCT07423546 — A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia · Phase 1, PHASE2 · not yet recruiting
NCT05339256 — Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual · Phase 2 · not yet recruiting
NCT05563948 — Repeated Administration of Cannabis Varying in THC and CBD · Phase 2 · suspended
NCT06977308 — A Multimodal Imaging Study of Dopamine in Early Psychosis · Phase 1 · not yet recruiting

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 NCT02294253 (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 New York State Psychiatric Institute
Last refreshed: 6 March 2020

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/NCT02294253.

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