Who is sponsoring NCT05704543?

NCT05704543 is sponsored by Indivior Inc..

What drugs are being tested in NCT05704543?

Interventions in NCT05704543: Buprenorphine Extended-Release Injection.

What condition does NCT05704543 study?

NCT05704543 studies Opioid Use Disorder.

Is NCT05704543 still recruiting?

NCT05704543 is currently completed. Last updated 7 January 2025.

Are results published for NCT05704543?

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

Last reviewed 2025-01-07 · How we verify

NCT05704543

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

Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations

Completed Phase 4 Results posted Last updated 7 January 2025

What this trial tests

Phase 4 trial testing Buprenorphine Extended-Release Injection in Opioid Use Disorder in 132 participants. Completed in 1 November 2023.

Timeline

1 March 2023

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	Indivior Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	132
Start date	1 March 2023
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	6 locations across United States

Drugs / interventions tested

Buprenorphine Extended-Release Injection

Conditions studied

Opioid Use Disorder — all drugs for Opioid Use Disorder →

Sponsor

Indivior Inc. — full company profile →

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.

Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine Primary · Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	1640	± 41.8
Extended-release Buprenorphine: Upper Arm	1720	± 57.4
Extended-release Buprenorphine: Buttocks	1570	± 42.7
Extended-release Buprenorphine: Thigh	1870	± 56.2

Maximum Observed Plasma Concentration (Cmax) of Buprenorphine Primary · Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	6.61	± 46.9
Extended-release Buprenorphine: Upper Arm	9.17	± 85.8
Extended-release Buprenorphine: Buttocks	7.11	± 39.7
Extended-release Buprenorphine: Thigh	10.1	± 73.2

Participants With Treatment-emergent Adverse Events Secondary · 28 days

Any treatment-emergent adverse event (TEAE)

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	22.7
Extended-release Buprenorphine: Upper Arm	14.3
Extended-release Buprenorphine: Buttocks	18.2
Extended-release Buprenorphine: Thigh	8.7

TEAE identified as injection site reaction

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	9.1
Extended-release Buprenorphine: Upper Arm	4.8
Extended-release Buprenorphine: Buttocks	4.5
Extended-release Buprenorphine: Thigh	4.3

Related TEAE

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	9.1
Extended-release Buprenorphine: Upper Arm	4.8
Extended-release Buprenorphine: Buttocks	13.6
Extended-release Buprenorphine: Thigh	4.3

Severe TEAE

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	0
Extended-release Buprenorphine: Upper Arm	0
Extended-release Buprenorphine: Buttocks	0
Extended-release Buprenorphine: Thigh	0

TEAE of opioid withdrawal symptom

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	0
Extended-release Buprenorphine: Upper Arm	0
Extended-release Buprenorphine: Buttocks	0
Extended-release Buprenorphine: Thigh	0

TEAE leading to death

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	0
Extended-release Buprenorphine: Upper Arm	0
Extended-release Buprenorphine: Buttocks	0
Extended-release Buprenorphine: Thigh	0

Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions Secondary · 28 days

Injection site erythema

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	4.5
Extended-release Buprenorphine: Upper Arm	0
Extended-release Buprenorphine: Buttocks	4.5
Extended-release Buprenorphine: Thigh	0

Injection site induration

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	0
Extended-release Buprenorphine: Upper Arm	4.8
Extended-release Buprenorphine: Buttocks	4.5
Extended-release Buprenorphine: Thigh	0

Injection site pain

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	4.5
Extended-release Buprenorphine: Upper Arm	4.8
Extended-release Buprenorphine: Buttocks	0
Extended-release Buprenorphine: Thigh	0

Injection site swelling

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	0
Extended-release Buprenorphine: Upper Arm	4.8
Extended-release Buprenorphine: Buttocks	0
Extended-release Buprenorphine: Thigh	4.3

Injection site reaction

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	4.5
Extended-release Buprenorphine: Upper Arm	0
Extended-release Buprenorphine: Buttocks	0
Extended-release Buprenorphine: Thigh	0

Number of Participants With Treatment-emergent Serious Adverse Events Secondary · 28 days

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	0
Extended-release Buprenorphine: Upper Arm	0
Extended-release Buprenorphine: Buttocks	0
Extended-release Buprenorphine: Thigh	0

Injection Site Grading Secondary · Day 1 at 10 minutes and 2 hours post dosing

Injection sites will be assessed for pain, tenderness, erythema/redness, induration, or swelling. Local injection site tolerability will be assigned a severity grade, including none (grade 0), mild (grade 1), moderate (grade 2), severe (grade 3), or potentially life-threatening (grade 4) utilizing the Injection Site Grading Scale.

Pain, None (Grade 0) at 10 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	59.1
Extended-release Buprenorphine: Upper Arm	57.1
Extended-release Buprenorphine: Buttocks	68.2
Extended-release Buprenorphine: Thigh	56.5

Pain, Mild (Grade 1) at 10 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	31.8
Extended-release Buprenorphine: Upper Arm	28.6
Extended-release Buprenorphine: Buttocks	18.2
Extended-release Buprenorphine: Thigh	34.8

Pain, Moderate (Grade 2) at 10 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	9.1
Extended-release Buprenorphine: Upper Arm	14.3
Extended-release Buprenorphine: Buttocks	13.6
Extended-release Buprenorphine: Thigh	8.7

Tenderness, None (Grade 0) at 10 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	59.1
Extended-release Buprenorphine: Upper Arm	66.7
Extended-release Buprenorphine: Buttocks	77.3
Extended-release Buprenorphine: Thigh	56.5

Tenderness, Mild (Grade 1) at 10 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	31.8
Extended-release Buprenorphine: Upper Arm	33.3
Extended-release Buprenorphine: Buttocks	22.7
Extended-release Buprenorphine: Thigh	39.1

Tenderness, Moderate (Grade 2) at 10 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	9.1
Extended-release Buprenorphine: Upper Arm	0
Extended-release Buprenorphine: Buttocks	0
Extended-release Buprenorphine: Thigh	4.3

Erythema/redness, None (Grade 0) at 10 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	86.4
Extended-release Buprenorphine: Upper Arm	81.0
Extended-release Buprenorphine: Buttocks	86.4
Extended-release Buprenorphine: Thigh	100.0

Erythema/redness, Mild (Grade 1) at 10 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	13.6
Extended-release Buprenorphine: Upper Arm	19.0
Extended-release Buprenorphine: Buttocks	13.6
Extended-release Buprenorphine: Thigh	0

Injection Site Pain Secondary · Day 1 at 1, 5, 10, 15, and 30 minutes post dosing

Measured on a 100 mm visual analog scale (VAS), where 0 represents no pain and 100 represents maximum pain.

1 minute

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	37.5	± 27.95
Extended-release Buprenorphine: Upper Arm	29.0	± 24.10
Extended-release Buprenorphine: Buttocks	27.4	± 32.02
Extended-release Buprenorphine: Thigh	29.3	± 28.99

5 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	23.2	± 26.13
Extended-release Buprenorphine: Upper Arm	16.0	± 16.59
Extended-release Buprenorphine: Buttocks	13.6	± 23.62
Extended-release Buprenorphine: Thigh	19.0	± 23.56

10 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	12.0	± 14.88
Extended-release Buprenorphine: Upper Arm	9.4	± 11.80
Extended-release Buprenorphine: Buttocks	8.2	± 14.15
Extended-release Buprenorphine: Thigh	12.5	± 21.30

15 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	4.8	± 6.58
Extended-release Buprenorphine: Upper Arm	6.0	± 8.76
Extended-release Buprenorphine: Buttocks	4.9	± 11.80
Extended-release Buprenorphine: Thigh	8.6	± 20.64

30 minutes

Group	Value	95% CI
Extended-release Buprenorphine: Abdomen	1.8	± 2.56
Extended-release Buprenorphine: Upper Arm	4.5	± 8.69
Extended-release Buprenorphine: Buttocks	1.4	± 2.46
Extended-release Buprenorphine: Thigh	6.6	± 19.93

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 86 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pre-injection (Run-In Period)

Serious: 0/132 (0%)

Deaths: 0/132

Extended-release Buprenorphine: Abdomen (Post-injection)

Serious: 0/22 (0%)

Deaths: 0/22

Extended-release Buprenorphine: Upper Arm (Post-injection)

Serious: 0/21 (0%)

Deaths: 0/21

Extended-release Buprenorphine: Buttocks (Post-injection)

Serious: 0/22 (0%)

Deaths: 0/22

Extended-release Buprenorphine: Thigh (Post-injection)

Serious: 0/23 (0%)

Deaths: 0/23

Other adverse events (7 terms — click to expand)

Reaction	System	Pre-injection (Run-In Peri…	Extended-release Buprenorp…	Extended-release Buprenorp…	Extended-release Buprenorp…	Extended-release Buprenorp…
Gastrointestinal disorders	Gastrointestinal disorders	—	—	—	—	—
Nervous system disorders	Nervous system disorders	—	—	—	—	—
Psychiatric disorders	Psychiatric disorders	—	—	—	—	—
Infections and infestations	Infections and infestations	—	—	—	—	—
General disorders and administration site conditions	General disorders	—	—	—	—	—
Investigations	Investigations	—	—	—	—	—
Immune system disorders	Immune system disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT05704543 adverse events section.

Sponsor's own description

Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous administration in the abdomen for treatment of opioid use disorder (OUD). Having alternative injection sites is desirable to provide additional flexibility to patients, particularly for those who may prefer less visible or more convenient injection locations. The primary objective of this study is to assess the relative bioavailability of extended-release buprenorphine when administered at alternative injection locations (test treatments), in comparison to the abdomen (reference treatment).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of Monthly Extended-Release Buprenorphine at Alternative Injection Locations in Adult Participants with Opioid Use Disorder.
Laffont CM, Lapeyra O, Mangal D, Dobbins R. · · 2024 · cited 4× · PMID 39543001 · DOI 10.1007/s40261-024-01406-7

Verify or expand the search:

Other recruiting trials for Opioid Use Disorder

Currently open trials in the same condition.

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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 NCT05704543 (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 Indivior Inc.
Last refreshed: 7 January 2025

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/NCT05704543.

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