Moderate to Severe Opioid Use DisorderPhase 2NCT06576843

INDV-6001 Multiple-Dose Pharmacokinetic Study

A Phase 2 study testing INDV-6001, Suboxone and Sublocade in people with Moderate to Severe Opioid Use Disorder, run by Indivior Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Moderate to Severe Opioid Use Disorder
What is being tested?: INDV-6001, Suboxone and Sublocade
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 11 sitesUnited States
Study dates: 17 Sep 2024to 21 Jan 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants are eligible to be included in any cohort open to enrolment in the study only if all of the following criteria apply:
Has signed the ICF and have the ability to understand and comply with the requirements and restrictions listed therein
Is an adult (male or female) between the ages of 18 and 65 years, inclusive, at the time of signing the ICF
Has a BMI of ≥18.0 to ≤33.0 kg/m2
Is seeking MOUD and currently meets or has documented history of moderate or severe OUD as per DSM-5 criteria. For Cohorts 1-4 only: can be dose-adjusted to 12 to 16 mg SUBOXONE QD or currently taking TM BUP for OUD and can be dose-adjusted to 12 to 16 mg SUBOXONE QD
Agrees not to take any BUP-containing products, other than those administered for the current study, throughout the duration of the study

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If a woman of childbearing potential, not pregnant or lactating and agrees to follow contraception guidelines per protocol; if a women of non-childbearing potential (WONCBP), is:
Postmenopausal (defined as no menses for 12 months without an alternative medical cause and confirmed by high FSH level of >30 mIU/mL in women not using hormonal contraception or hormonal replacement therapy) or
Permanently sterilised (eg, bilateral tubal occlusion, bilateral tubal ligation, complete hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
If a man, agrees to follow contraception guidelines per protocol 5.2 Exclusion Criteria
A participant will not be eligible for inclusion in this study if any of the following criteria apply:
Has current diagnosis or medical condition, other than OUD, requiring chronic opioid treatment
Has a concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis, or mild to moderate alcohol use disorders
Has an injection area unsuitable for SC injections (eg, nodules, scarring, lesions, excessive pigment) in the areas designated for possible injection in the study
Is currently using another MOUD treatment other than TM BUP (eg, SUBOXONE) or has had prior treatment with any long-acting injectable form of a BUP-containing product in the past 18 months (or if 18-24 months with a positive UDS) prior to consent; treatment with oral naltrexone or methadone products within 14 days prior to consent (or positive UDS for methadone at Screening); or treatment with depot naltrexone within the 3 months prior to consent
Has had significant traumatic injury or major surgical procedure (as defined by the investigator) within 30 days prior to the first dose of INDV-6001 or still recovering from such prior injury or surgery
Has congenital long QT syndrome, history of prolonged QT in the 3 months prior to screening, or a corrected QT interval (Fridericia's - QTcF) >450 msec (male) or >470 msec (female), or history of risk factors for Torsades de Pointes. Has known personal history of taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone) or other mediations that prolong the QT interval
Has known family history of congenital QT prolongation or sudden unexplained death
Is currently taking (within the 30 days prior to signing the ICF) prescription or OTC medications that are clinically relevant moderate or strong cytochrome P450 (CYP) 3A4 or CYP 2C8 inducers or inhibitors (eg, rifampin, azole antifungals [eg, ketoconazole], macrolide antibiotics [eg, erythromycin])
Has a history of suicidal ideation within 30 days prior to providing written informed consent (evidenced by answering yes to either question 1 or 2 on the C-SSRS) or a history of a suicide attempt in the 6 months prior to consent
Has any active medical condition (including organ disease), psychiatric illness, social/legal situation (including court order requiring treatment for OUD), or concurrent medication/treatment that may compromise participant safety, interfere with study endpoints, limit compliance with study requirements, or compromise the ability of the participant to provide written informed consent
Has active hepatitis B or C as evidenced by positive serology and PCR test confirmation
Has total bilirubin ≥1.5 × ULN (with direct bilirubin >20% of total bilirubin), ALT ≥3 × ULN, AST ≥3 × ULN, or INR >1.5 × ULN at Screening)
Has serum creatinine >1.5 × ULN or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 by CKD-EPI formula
Has known allergy or hypersensitivity to BUP, any excipients of INDV-6001, SUBOXONE, or SUBLOCADE
Is currently participating in another interventional clinical study, and/or has been treated with investigational product INDV-2000 within 1 month prior to Screening Visit, or another investigational agent within 3 months prior to Screening Visit
Is currently being treated with medications contraindicated for use with BUP as per local prescribing information
Has donated more than 500 mL of blood within the past 3 months prior to consent
Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (eg, site staff or Indivior employee)

Who cannot join

None listed.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Progressive Clinical Research
Bountiful, Utah, 84010
Chicago Clinical Research Institute Inc.
Chicago, Illinois, 60607
Midwest Clinical Research
Dayton, Ohio, 45417
Insite Clinical Research, LLC
DeSoto, Texas, 75115
Precise Research Centers
Flowood, Mississippi, 39232
Memorial Hermann Village
Houston, Texas, 77043
Hassman Research Institute (Cenexel HRI - Marlton)
Marlton, New Jersey, 08053
Innovative Clinical Research, Inc.
Miami Lakes, Florida, 33016
Pillar Clinical Research
Richardson, Texas, 75080
Artemis Institute for Clinical Research
San Diego, California, 92103
Richmond Behavioral Associates
Staten Island, New York, 10314

Other trials in United States

About this study

Official title: An Open-label, Multicentre Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Repeated Doses of INDV-6001 in Adults With Moderate to Severe Opioid Use Disorder

The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of INDV-6001 following multiple doses in participants with OUD to select optimum dosing regimens for future studies. Prior to receiving INDV-6001, participants will be stabilised on 12-16 mg of transmucosal (TM) BUP (SUBOXONE®) or will transition from a 100-mg monthly maintenance dose of SC extended-release BUP (SUBLOCADE®). This study will also evaluate the use of alternative injection sites (thigh, back of upper arm), which may be desirable in this patient population for the anticipated extended durations of treatment.

Read the detailed description

Study Cohorts:

There are multiple cohorts (1, 2, 3, 4 and 7) testing varying dose strengths and frequencies of INDV-6001 in participants who are not receiving long-acting treatment for OUD. Up to 15 participants from each of the Cohorts 1, 2, 3, and 4 will enrol into Cohorts 1a, 2a, 3a, and 4a, respectively.

Study Periods:

Screening Period: from the Screening Visit until prior to the first SUBOXONE or SUBLOCADE dose as a part of this study Pre-Investigational Medicinal Product (IMP) Period: from the first SUBOXONE or SUBLOCADE dose as a part of this study until prior to the first INDV-6001 dose IMP Period: from the first INDV-6001 dose until the SUBLOCADE injection (Cohorts 3a and 4a only) or until the end of the study (EOS; all remaining cohorts) Post-IMP Period: (Cohorts 3a and 4a only) from the SUBLOCADE injection until EOS

Conditions: Moderate to Severe Opioid Use Disorder
Being tested: INDV-6001, Suboxone, Sublocade

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INDV-6001Drug
Extended-release subcutaneous injection
SuboxoneDrug
Oral sublingual film
SublocadeDrug
Extended-release subcutaneous injection

Study groups in NCT06576843
Study group	Role	What they receive
Cohort 1	Experimental	SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 600 mg on Day 8, Day 92, and Day 176) Receives: Drug: INDV-6001; Drug: Suboxone
Cohort 2	Experimental	SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 600 mg on Day 8, Day 64, Day 120, and Day 176) Receives: Drug: INDV-6001; Drug: Suboxone
Cohort 3	Experimental	SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, 600 mg Day 8, followed by 250 mg on Day 15, Day 43, Day 71, and Day 99) Receives: Drug: INDV-6001; Drug: Suboxone
Cohort 4	Experimental	SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 100 mg on Day 8, Day 36, Day 64, and Day 92) Receives: Drug: INDV-6001; Drug: Suboxone
Cohort 1a	Experimental	In Cohort 1, up to 15 participants who reach Day 260 will be enrolled into Cohort 1a. Participants in Cohort 1a will receive an additional injection of INDV-6001 600 mg in the back of the upper arm on Day 260. Receives: Drug: INDV-6001
Cohort 2a	Experimental	In Cohort 2, up to 15 participants who reach Day 232 will be enrolled into Cohort 2a. Participants in Cohort 2a will receive an additional injection of INDV-6001 600 mg in the thigh on Day 232. Receives: Drug: INDV-6001
Cohort 3a	Experimental	In Cohort 3, up to 15 participants who reach Day 127 will be enrolled into Cohort 3a. Participants in Cohort 3a will receive an injection of SUBLOCADE 300 mg (abdomen) on Day 127. Receives: Drug: Sublocade
Cohort 4a	Experimental	In Cohort 4, up to 15 participants who reach Day 120 will be enrolled in Cohort 4a. Participants in Cohort 4a will receive an injection of SUBLOCADE 100 mg (abdomen) on Day 120. Receives: Drug: Sublocade
Cohort 7	Experimental	Participants in Cohort 7 who are new to BUP treatment will undergo rapid induction with SUBLOCADE 300 mg (per product labelling) in the abdomen on Day 1 following an initial dose of SUBOXONE (eg, 4 mg). All participants in Cohort 7 will receive: SUBLOCADE 300 mg (abdomen) on Day 1 and Day 8, SUBLOCADE 100 mg (abdomen) on Day 36, and 600mg INDV-6001 on Day 64. Receives: Drug: INDV-6001; Drug: Suboxone; Drug: Sublocade

What is being measured

The primary outcome is the main question the study is designed to answer.

Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the abdomen
AUCtau for Cohorts 1-4
Measured: Up to 260 days
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the abdomen
Cmax for Cohorts 1-4
Measured: Up to 260 days
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the abdomen
Tmax for Cohorts 1-4
Measured: Up to 260 days
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the abdomen
Cmin for Cohorts 1-4
Measured: Up to 260 days
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection in the abdomen
Ctrough for Cohorts 1-4
Measured: Up to 260 days
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the abdomen
Cavg for Cohorts 1-4
Measured: Up to 260 days
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 injection
% fluctuation for Cohorts 1-4
Measured: Up to 260 days
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
AUCtau for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Measured: Up to 168 days [24 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Cmax for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Measured: Up to 168 days [24 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Tmax for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Measured: Up to 168 days [24 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Cmin for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Measured: Up to 168 days [24 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Ctrough for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Measured: Up to 168 days [24 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Cavg for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Measured: Up to 168 days [24 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
% fluctuation for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Measured: Up to 168 days [24 weeks]
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
AUCtau for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Measured: Up to 128 days [16 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Cmax for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Measured: Up to 128 days [16 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Tmax for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Measured: Up to 128 days [16 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Cmin for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Measured: Up to 128 days [16 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Ctrough for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Measured: Up to 128 days [16 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Cavg for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Measured: Up to 128 days [16 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
% fluctuation for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Measured: Up to 128 days [16 weeks]

Secondary outcomes (22)

Assessment of the safety and tolerability of INDV-6001 injection
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs leading to discontinuation, fatal TEAEs, and AEs of special interest (AESIs) for All Cohorts
Measured: Up to 260 days
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
AUCtau for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Cmax for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Tmax for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Cmin for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Ctrough for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Cavg for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
%fluctuation for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
AUCtau for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Cmax for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Tmax for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Cmin for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Ctrough for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Cavg for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
% fluctuation for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 56 days [8 weeks]
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
AUCtau for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 112 days [16 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Cmax for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 112 days [16 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Tmax for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 112 days [16 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Cmin for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 112 days [16 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Ctrough for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 112 days [16 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Cavg for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 112 days [16 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
% fluctuation for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]
Measured: Up to 112 days [16 weeks]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 202421 Jan 2026

First posted29 Aug 2024
Study start17 Sep 2024
Primary completion21 Jan 2026
Study completion21 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Moderate to Severe Opioid Use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06576843
Sponsor's protocol ID: INDV-6001-201
Status last verified: Mar 2026
First submitted: 27 Aug 2024
Last updated: 16 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multicentre Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Repeated Doses of INDV-6001 in Adults With Moderate to Severe Opioid Use Disorder
ClinicalTrials.gov ID: NCT06576843
Acronym / sponsor ID: INDV-6001-201
Conditions: Moderate to Severe Opioid Use Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Indivior Inc.Industry (pharma, biotech, devices)
Study start: 17 Sep 2024 (actual)
Primary completion: 21 Jan 2026 (actual)
Study completion: 21 Jan 2026 (actual)
First posted: 29 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Cohorts:

Study Periods:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 9

Arm	Type	Receives
Cohort 1	Experimental	Drug: INDV-6001, Drug: SuboxoneSUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 600 mg on Day 8, Day 92, and Day 176)
Cohort 2	Experimental	Drug: INDV-6001, Drug: SuboxoneSUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 600 mg on Day 8, Day 64, Day 120, and Day 176)
Cohort 3	Experimental	Drug: INDV-6001, Drug: SuboxoneSUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, 600 mg Day 8, followed by 250 mg on Day 15, Day 43, Day 71, and Day 99)
Cohort 4	Experimental	Drug: INDV-6001, Drug: SuboxoneSUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 100 mg on Day 8, Day 36, Day 64, and Day 92)
Cohort 1a	Experimental	Drug: INDV-6001In Cohort 1, up to 15 participants who reach Day 260 will be enrolled into Cohort 1a. Participants in Cohort 1a will receive an additional injection of INDV-6001 600 mg in the back of the upper arm on Day 260.
Cohort 2a	Experimental	Drug: INDV-6001In Cohort 2, up to 15 participants who reach Day 232 will be enrolled into Cohort 2a. Participants in Cohort 2a will receive an additional injection of INDV-6001 600 mg in the thigh on Day 232.
Cohort 3a	Experimental	Drug: SublocadeIn Cohort 3, up to 15 participants who reach Day 127 will be enrolled into Cohort 3a. Participants in Cohort 3a will receive an injection of SUBLOCADE 300 mg (abdomen) on Day 127.
Cohort 4a	Experimental	Drug: SublocadeIn Cohort 4, up to 15 participants who reach Day 120 will be enrolled in Cohort 4a. Participants in Cohort 4a will receive an injection of SUBLOCADE 100 mg (abdomen) on Day 120.
Cohort 7	Experimental	Drug: INDV-6001, Drug: Suboxone, Drug: SublocadeParticipants in Cohort 7 who are new to BUP treatment will undergo rapid induction with SUBLOCADE 300 mg (per product labelling) in the abdomen on Day 1 following an initial dose of SUBOXONE (eg, 4 mg). All participants in Cohort 7 will receive: SUBLOCADE 300 mg (abdomen) on Day 1 and Day 8, SUBLOCADE 100 mg (abdomen) on Day 36, and 600mg INDV-6001 on Day 64.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (29 listed)

Participants are eligible to be included in any cohort open to enrolment in the study only if all of the following criteria apply:
Has signed the ICF and have the ability to understand and comply with the requirements and restrictions listed therein
Is an adult (male or female) between the ages of 18 and 65 years, inclusive, at the time of signing the ICF
Has a BMI of ≥18.0 to ≤33.0 kg/m2
Is seeking MOUD and currently meets or has documented history of moderate or severe OUD as per DSM-5 criteria. For Cohorts 1-4 only: can be dose-adjusted to 12 to 16 mg SUBOXONE QD or currently taking TM BUP for OUD and can be dose-adjusted to 12 to 16 mg SUBOXONE QD

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INDV-6001Extended-release subcutaneous injection	Drug	Cohort 1, Cohort 1a, Cohort 2, Cohort 2a, Cohort 3, Cohort 4, Cohort 7
SuboxoneOral sublingual film	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 7
SublocadeExtended-release subcutaneous injection	Drug	Cohort 3a, Cohort 4a, Cohort 7

Primary outcome

Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the abdomen
Time frame: Up to 260 days
AUCtau for Cohorts 1-4
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the abdomen
Time frame: Up to 260 days
Cmax for Cohorts 1-4
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the abdomen
Time frame: Up to 260 days
Tmax for Cohorts 1-4
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the abdomen
Time frame: Up to 260 days
Cmin for Cohorts 1-4
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection in the abdomen
Time frame: Up to 260 days
Ctrough for Cohorts 1-4
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the abdomen
Time frame: Up to 260 days
Cavg for Cohorts 1-4
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 injection
Time frame: Up to 260 days
% fluctuation for Cohorts 1-4
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Time frame: Up to 168 days [24 weeks]
AUCtau for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Time frame: Up to 168 days [24 weeks]
Cmax for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Time frame: Up to 168 days [24 weeks]
Tmax for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Time frame: Up to 168 days [24 weeks]
Cmin for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Time frame: Up to 168 days [24 weeks]
Ctrough for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Time frame: Up to 168 days [24 weeks]
Cavg for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location
Time frame: Up to 168 days [24 weeks]
% fluctuation for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Time frame: Up to 128 days [16 weeks]
AUCtau for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Time frame: Up to 128 days [16 weeks]
Cmax for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Time frame: Up to 128 days [16 weeks]
Tmax for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Time frame: Up to 128 days [16 weeks]
Cmin for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Time frame: Up to 128 days [16 weeks]
Ctrough for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Time frame: Up to 128 days [16 weeks]
Cavg for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location
Time frame: Up to 128 days [16 weeks]
% fluctuation for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]

22 secondary outcomes

Assessment of the safety and tolerability of INDV-6001 injection
Time frame: Up to 260 days
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 56 days [8 weeks]
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 112 days [16 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 112 days [16 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 112 days [16 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 112 days [16 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 112 days [16 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 112 days [16 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen
Time frame: Up to 112 days [16 weeks]

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INDV-6001, Suboxone and Sublocade in people with Moderate to Severe Opioid Use Disorder, run by Indivior Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the abdomen (time frame: Up to 260 days). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06576843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.