NCT03993392 is a Phase 4 clinical trial of TM buprenorphine in Opioid-use Disorder, sponsored by Indivior Inc..

Who is sponsoring NCT03993392?

NCT03993392 is sponsored by Indivior Inc..

What drugs are being tested in NCT03993392?

Interventions in NCT03993392: TM buprenorphine, SUBLOCADE.

What condition does NCT03993392 study?

NCT03993392 studies Opioid-use Disorder.

Is NCT03993392 still recruiting?

NCT03993392 is currently completed. Last updated 25 March 2025.

Are results published for NCT03993392?

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

Last reviewed 2025-03-25 · How we verify

NCT03993392

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

SUBLOCADE Rapid Initiation Study

Completed Phase 4 Results posted Last updated 25 March 2025

What this trial tests

Phase 4 trial testing TM buprenorphine in Opioid-use Disorder in 26 participants. Completed in 26 December 2019.

Timeline

29 August 2019

Primary endpoint
26 December 2019

26 December 2019

Quick facts

Lead sponsor	Indivior Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	29 August 2019
Primary completion	26 December 2019
Estimated completion	26 December 2019
Sites	1 location across United States

Drugs / interventions tested

TM buprenorphine — full drug profile →
SUBLOCADE — full drug profile →

Conditions studied

Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

Indivior Inc. — full company profile →

Who can join

18 and older, 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.

Participants Who Experienced Any Precipitated Withdrawal Within One Hour After SUBLOCADE Administration Primary · Day 1: Pre-SUBLOCADE evaluation taken after TM buprenorphine treatment and prior to injection: SUBLOCADE evaluation taken within one hour of SUBLOCADE injection

Clinical Opiate Withdrawal Scale (COWS) is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Precipitated withdrawal was defined as in increase in Clinical Opioid Withdra

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	1

Participants With Treatment-Emergent Adverse Events (TEAE) Secondary · Day 1 to Day 28

A TEAE was an AE that started after the administration of TM buprenorphine for induction on Day 1. TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or sign

Any TEAE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	20

Study Drug-related TEAE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	5

Serious TEAE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	0

Related and Serious TEAE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	0

Severe TEAE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	5

TEAE leading to death

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	0

TEAE leading to discontinuation of drug

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	0

TEAE leading to interruption of drug

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	0

Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection Secondary · Day 1 SUBLOCADE injection up to 48 hours later

Any TEAE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	19

Study Drug-related TEAE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	4

Serious TEAE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	0

Related and Serious TEAE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	0

Severe TEAE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	5

TEAE leading to death

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	0

TEAE leading to discontinuation of drug

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	0

TEAE leading to interruption of drug

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	0

Cumulative Number of Participants Who Experienced a >=6 Point Clinical Opiate Withdrawal Scale (COWS) Total Score Increase After SUBLOCADE Administration From the Pre-SUBLOCADE Value at Key Timepoints Secondary · Day 1: Pre-SUBLOCADE evaluation taken after TM buprenorphine treatment and prior to injection: SUBLOCADE evaluations taken 1, 6, 12, 24 and 48 hours after SUBLOCADE injection.

COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Cumulative number of participants in key timepoints who had a COWS total score increase of ≥6 points from the pr

>0 to 1 hour

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	1

> 1 to 6 hours

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	2

>6 to 12 hours

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	2

>12 to 24 hours

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	2

>24 to 48 hours

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	2

COWS Total Score Normalized Area Under the Curve (AUC) Through Key Timepoints Post SUBLOCADE Injection Secondary · SUBLOCADE injection on Day 1 through 1, 6, 12, 24 and 48 hours after SUBLOCADE injection

The area under the curve (AUC) for COWS total score from the pre-SUBLOCADE value to a later time point were calculated using the linear trapezoidal method. For each analysis time interval (AUC0-1hr, AUC0-6hrs, AUC0-12hrs, AUC0-24hrs, AUC0-48hrs) the AUC value was normalized across participants for the actual duration (in hours) of the time interval. The normalized AUC for COWS can be interpreted as the averaged AUC per hour or the averaged COWS over a time interval, as if the COWS was measured hourly during that time interval. Participants were included in a given interval if they had a pre-S

Through 1 hour post SUBLOCADE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	11.91	± 3.700

Through 6 hours post SUBLOCADE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	9.27	± 3.939

Through 12 hours post SUBLOCADE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	7.91	± 3.772

Through 24 hours post SUBLOCADE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	6.59	± 3.021

Through 48 hours post SUBLOCADE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	5.03	± 2.566

Total Score on COWS At Timepoints During the Treatment Period Secondary · Day 1 to Day 29

Day 1 Check-in

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	12.5	± 3.74

Pre TM Buprenephrine

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	14.6	± 4.13

Pre-SUBLOCADE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	12.6	± 4.05

1 hour post-SUBLOCADE dose

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	11.1	± 4.51

2 hours post-SUBLOCADE dose

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	10.1	± 4.99

3 hours post-SUBLOCADE dose

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	9.1	± 5.32

4 hours post-SUBLOCADE dose

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	8.0	± 3.93

6 hours post-SUBLOCADE dose

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	6.9	± 4.06

Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period Secondary · Day 1 to Day 29

Participants indicated their level of craving for opioids by marking a 100mm visual analogue scale where 0 = no craving and 100 = maximal craving.

Day 1 Check-in

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	66.0	± 22.03

Pre TM Buprenephrine

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	65.0	± 31.06

Pre-SUBLOCADE

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	57.0	± 28.91

1 hour post-SUBLOCADE dose

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	56.5	± 26.52

2 hours post-SUBLOCADE dose

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	52.8	± 29.99

3 hours post-SUBLOCADE dose

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	53.9	± 30.22

4 hours post-SUBLOCADE dose

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	44.5	± 29.75

6 hours post-SUBLOCADE dose

Group	Value	95% CI
TM Buprenorphine Followed by SUBLOCADE 300 mg	42.6	± 26.98

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 to Day 29. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Induction Phase

Serious: 0/26 (0%)

Deaths: 0/26

Safety Population (Post -SUBLOCADE)

Serious: 0/24 (0%)

Deaths: 0/24

Other adverse events (18 terms — click to expand)

Reaction	System	Induction Phase	Safety Population (Post -S…
Irritability	Psychiatric disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Anxiety	Psychiatric disorders	—	—
Pain	General disorders	—	—
Insomnia	Psychiatric disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Chills	General disorders	—	—
Injection site bruising	General disorders	—	—
Agitation	Psychiatric disorders	—	—
Injection site erythema	General disorders	—	—
Drug withdrawal syndrome	General disorders	—	—
Gastroenteritis viral	Infections and infestations	—	—
Herpes zoster	Infections and infestations	—	—
Infusion site cellulitis	Infections and infestations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03993392 adverse events section.

Sponsor's own description

This study is to evaluate the safety and tolerability of initiating SUBLOCADE™ treatment following a shorter period of transmucosal (TM) buprenorphine treatment.

Publications & conference data

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

Open-label, rapid initiation pilot study for extended-release buprenorphine subcutaneous injection.
Hassman H, Strafford S, Shinde SN, Heath A, et al · · 2023 · cited 11× · PMID 36001871 · DOI 10.1080/00952990.2022.2106574

Verify or expand the search:

Other recruiting trials for Opioid-use Disorder

Currently open trials in the same condition.

NCT04783558 — Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk · NA · active not recruiting
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 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 NCT03993392 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 25 March 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/NCT03993392.

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