Sublocade Induction
Primary
· Study week 1
Number of participants successfully inducted onto Sublocade (BXR)
| Group | Value | 95% CI |
|---|---|---|
| Sublocade | 10 |
Last reviewed · How we verify
NCT03861338
An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder
Completed
Phase 1, PHASE2
Results posted
Last updated 9 March 2021
What this trial tests
Phase 1, PHASE2 trial testing Sublocade in Opioid-use Disorder in 11 participants. Completed in 28 February 2020.
Timeline
1 March 2019
Primary endpoint
28 February 2020
28 February 2020
28 February 2020
Quick facts
| Lead sponsor | New York State Psychiatric Institute |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 1 March 2019 |
| Primary completion | 28 February 2020 |
| Estimated completion | 28 February 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sublocade — full drug profile →
Conditions studied
- Opioid-use Disorder — all drugs for Opioid-use Disorder →
Sponsor
New York State Psychiatric Institute
Who can join
Adults 18 to 65, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 weeks of study. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Sublocade
Serious: 0/10 (0%)
Deaths: 0/10
Other adverse events (20 terms — click to expand)
| Reaction | System | Sublocade |
|---|---|---|
| opioid withdrawal | General disorders | — |
| cough | Respiratory, thoracic and mediastinal disorders | — |
| injection site pain | Skin and subcutaneous tissue disorders | — |
| anorexia | Gastrointestinal disorders | — |
| headache | General disorders | — |
| pruritis | Skin and subcutaneous tissue disorders | — |
| blurred vision | Eye disorders | — |
| constipation | Gastrointestinal disorders | — |
| depression | Psychiatric disorders | — |
| difficulties with memory | Nervous system disorders | — |
| fever | General disorders | — |
| loss of libido | General disorders | — |
| tremor | Nervous system disorders | — |
| increase in weight | Metabolism and nutrition disorders | — |
| toothache | General disorders | — |
| elevated liver functions | Endocrine disorders | — |
| Urinary Tract Infection | Infections and infestations | — |
| pharyngitis | Respiratory, thoracic and mediastinal disorders | — |
| sinusitis | Respiratory, thoracic and mediastinal disorders | — |
| neck pain | Musculoskeletal and connective tissue disorders | — |
Data from ClinicalTrials.gov NCT03861338 adverse events section.
Sponsor's own description
The proposed study is a 12-week, open-label pilot study of sublocade (extended-release burprenorphine, BXR) as treatment for opiate use disorder (OUD) testing positive for Highly Potent Synthetic Opioids (HPSO). The investigators plan to enroll 10 participants into the study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Open-label trial of a single-day induction onto buprenorphine extended-release injection for users of heroin and fentanyl.
Mariani JJ, Mahony AL, Podell SC, Brooks DJ, et al · · 2021 · cited 20× · PMID 34223681 · DOI 10.1111/ajad.13193
Verify or expand the search:
- PubMed search for NCT03861338
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sublocade
Trials testing the same drug.
- NCT06576843 — INDV-6001 Multiple-Dose Pharmacokinetic Study · Phase 2 · completed
- NCT04060654 — SUBLOCADE Rapid Initiation Extension Study · Phase 4 · completed
Other recruiting trials for Opioid-use Disorder
Currently open trials in the same condition.
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- NCT05011266 — Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder · Phase 2, PHASE3 · recruiting
- NCT05039554 — Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment · NA · recruiting
- NCT05033028 — Smartphones for Opiate Addiction Recovery · Phase 3 · recruiting
- NCT04738825 — Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With Pr · NA · 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 NCT03861338 (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 New York State Psychiatric Institute
- Last refreshed: 9 March 2021
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/NCT03861338.
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