Opioid Use DisordersPhase 3NCT02651584
Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
A Phase 3 study testing CAM2038 SC injection and SL BPN/NX tabs in people with Opioid Use Disorders, run by Braeburn Pharmaceuticals at 36 sites in United States.
Trial summary
Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorders
- What is being tested?
- CAM2038 SC injection and SL BPN/NX tabs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 428 participants
- Where
- 36 sitesUnited States
- Study dates
- Dec 2015to Nov 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject must provide written informed consent prior to the conduct of any trial-related procedures.
- Male or female, 18-65 years of age, inclusive.
- Diagnosis of moderate or severe opioid use disorder as described (DSM-V).
- Voluntarily seeking treatment for opioid use disorder.
- Have not received medication-assisted treatment for opioid use disorder within 60 days prior to randomization.
- Considered by the Investigator to be a good candidate for BPN treatment, based on medical and psychosocial history.
- Male or Female subjects of childbearing potential must be willing to use a reliable method of contraception during the entire trial (Screening visit to Follow-up visit)
Who cannot join
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).
- Current diagnosis of chronic pain requiring opioids for treatment.
- Current DSM-V diagnosis of moderate to severe substance use disorder on any other psychoactive substances other than opioids, caffeine or nicotine (e.g., alcohol, cocaine, sedatives).
- Pregnant or lactating or planning to become pregnant during the trial.
- Hypersensitivity or allergy to BPN or other opioids, naloxone or other opioid antagonists, or excipients of CAM2038 or SL BPN.
- Requires current use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) such as some azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir).
Show all 14Show fewer
- Subjects with active signs or symptoms of hepatitis and requiring treatment. Subjects with no acute signs of inflammation, and no clinical necessity for therapy will be allowed, at the discretion of the Investigator.
- Recent history of or current evidence of suicidal ideation or active suicidal behavior as based on the Columbia Suicide Severity Rating Scale (C-SSRS) ("Yes" responses to questions 4 or 5).
- Any pending legal action that could prohibit participation or compliance in the trial.
- Exposure to any investigational drug within the 4 weeks prior to Screening.
- Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or an electrocardiogram (ECG) demonstrating a Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF >470 in females at screening.
- Aspartate aminotransferase (AST) levels >3 X the upper limit of normal, alanine aminotransferase (ALT) levels >3 X the upper limit of normal, total bilirubin >1.5 X the upper limit of normal, or creatinine >1.5 X upper limit of normal on the Screening laboratory assessments, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the subject from safely participating in trial.
- Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the trial or obtaining informed consent, or may prevent the subject from safely participating in trial (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator's Brochure for CAM2038).
- Is an employee of the Investigator or the trial site, with direct involvement in the proposed trial or other trials under the direction of the Investigator or trial site, or is a family member of an employee or of the Investigator.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Wellness and Research Center
Belvidere, New Jersey, 07823
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Parkway Medical Center
Birmingham, Alabama, 35215
University of Vermont
Burlington, Vermont, 05401
Neuro-Behavioral Clinical Research Center
Canton, Ohio, 44718
Carolina Clinical Trials, Inc
Charleston, South Carolina, 29407
Frost Medical Group
Conshohocken, Pennsylvania, 19428
InSite Clinical Research
Dallas, Texas, 75115
Midwest Clinical Research Center
Dayton, Ohio, 45417
Stanley Street Treatment and Resources Inc
Fall River, Massachusetts, 02720
Precise Research Centers
Flowood, Mississippi, 39232
Haleyville Clinical Research LLC
Haleyville, Alabama, 35565
Boyett Health Services Inc
Hamilton, Alabama, 35570
Dr Vijapura and Associates
Jacksonville, Florida, 32256
Innovative Clinical Research Inc
Lauderhill, Florida, 33319
Synergy East
Lemon Grove, California, 91945
University of Kentucky Medical Center
Lexington, Kentucky, 40508
Lincoln Research
Lincoln, Rhode Island, 02865
TRY Research
Maitland, Florida, 32751
Tellus Clinical Research, Inc.
Miami, Florida, 33173
North Star Medical Research
Middleburg Heights, Ohio, 44130
Novex Clinical Research
New Bedford, Massachusetts, 02740
STARS/Columbia University
New York, New York, 10019
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
North County Clinical Research
Oceanside, California, 92056
Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, 73112
Aspen Clinical Research
Orem, Utah, 84058
Asclepes Research
Panorama City, California, 91402
The University of Pennsylvania Health System Treatment Research Center
Philadelphia, Pennsylvania, 19104
Artemis Institute for Clinical Research
San Diego, California, 92103
Care Practice
San Francisco, California, 94708
Swedish Health Services
Seattle, Washington, 98107
PsychCare Consultants Research
St Louis, Missouri, 63128
St. Louis Clinical Trials
St Louis, Missouri, 63141
Synergist Research
West Hollywood, California, 90046
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203
About this study
Official title: A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel Group, Multi-center Trial Assessing the Efficacy and Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Treatment of Adult Outpatients With Opioid Use Disorder
Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN.
Read the detailed description
This is a Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN. The trial will involve 4 phases: Screening, Phase 1 (weekly visits), Phase 2 (monthly visits), and Follow-up.
Approximately 380 subjects (190 subjects per arm) will be randomized.
- Conditions
- Opioid Use Disorders
- Being tested
- CAM2038 SC injection, SL BPN/NX tabs, placebo SC injections, SL placebo tablets
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAM2038 SC injectionDrug
Also called Buprenorphine injection
SL BPN/NX tabsDrug
Also called Suboxone
placebo SC injectionsDrug
Also called placebo
SL placebo tabletsDrug
Also called placebo
| Study group | Role | What they receive |
|---|---|---|
| SL BPN/NX tabs + placebo SC injections | Experimental | SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.
CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w). Receives: Drug: SL BPN/NX tabs; Drug: placebo SC injections |
| CAM2038 SC injections + SL placebo tabs | Experimental | CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 or 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).
CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).
SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily Receives: Drug: CAM2038 SC injection; Drug: SL placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate, Denoted by Response Rate (Weeks 1-24).
Response Rate, denoted by response rate (Weeks 1-24). A responder is defined as a subject with at least 33% of urine toxicology results collected during the Phase 1 (4 out of 12 urine samples) and 67% of urine toxicology results collected during Phase 2 (4 out of 6 urine samples) being negative for illicit opioids and self - reported illicit opioid use.
Measured: 24 weeks
Secondary outcomes (3)
Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids
Cumulative distribution function (CDF) of percentage of urine samples negative for illicit opioids comparing CAM2038 to SL BPN/NX as (supported by self-reported opioid use results)
Measured: 24 weeks
Number of Subjects With Sustained Abstinence of Opioid Use
Number of Subjects with Sustained Abstinence of Opioid Use taking SL BPN/NX and CAM2038
Measured: 24 weeks
Number of Subjects Remaining in the Study (Retention Rate)
Number of Subjects Remaining in the Study (Retention Rate) on SL BPN/NX and CAM2038
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braeburn Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Braeburn Pharmaceuticals, Study chair, Braeburn Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651584
- Sponsor's protocol ID
- HS-11-421
- Status last verified
- Aug 2018
- First submitted
- 30 Dec 2015
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Peterson S, Nunes EV, Lofwall MR, Walsh SL, Tiberg F. Exploring Opioid Use Disorder Outcomes by Quantitative Urinalysis: Post Hoc Analysis of a Phase 3 Randomized Clinical Trial. J Addict Med. 2025 May-Jun 01;19(3):260-267. doi: 10.1097/ADM.0000000000001405. Epub 2024 Dec 4.
PubMed 39629836Nunes EV, Comer SD, Lofwall MR, Walsh SL, Peterson S, Tiberg F, Hjelmstrom P, Budilovsky-Kelley NR. Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder With Fentanyl Use: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417377. doi: 10.1001/jamanetworkopen.2024.17377.
PubMed 38916892Lofwall MR, Walsh SL, Nunes EV, Bailey GL, Sigmon SC, Kampman KM, Frost M, Tiberg F, Linden M, Sheldon B, Oosman S, Peterson S, Chen M, Kim S. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jun 1;178(6):764-773. doi: 10.1001/jamainternmed.2018.1052.
PubMed 29799968
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel Group, Multi-center Trial Assessing the Efficacy and Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Treatment of Adult Outpatients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT02651584
- Acronym / sponsor ID
- HS-11-421
- Conditions
- Opioid Use Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Braeburn PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Posted 22 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN.
Detailed description
This is a Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN. The trial will involve 4 phases: Screening, Phase 1 (weekly visits), Phase 2 (monthly visits), and Follow-up.
Approximately 380 subjects (190 subjects per arm) will be randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SL BPN/NX tabs + placebo SC injections | Experimental | Drug: SL BPN/NX tabs, Drug: placebo SC injectionsSL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day. CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w). |
| CAM2038 SC injections + SL placebo tabs | Experimental | Drug: CAM2038 SC injection, Drug: SL placebo tabletsCAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 or 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection). CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection). SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must provide written informed consent prior to the conduct of any trial-related procedures.
- Male or female, 18-65 years of age, inclusive.
- Diagnosis of moderate or severe opioid use disorder as described (DSM-V).
- Voluntarily seeking treatment for opioid use disorder.
- Have not received medication-assisted treatment for opioid use disorder within 60 days prior to randomization.
Key exclusion criteria (14 listed)
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).
- Current diagnosis of chronic pain requiring opioids for treatment.
- Current DSM-V diagnosis of moderate to severe substance use disorder on any other psychoactive substances other than opioids, caffeine or nicotine (e.g., alcohol, cocaine, sedatives).
- Pregnant or lactating or planning to become pregnant during the trial.
- Hypersensitivity or allergy to BPN or other opioids, naloxone or other opioid antagonists, or excipients of CAM2038 or SL BPN.
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 |
|---|---|---|
| CAM2038 SC injectionAlso: Buprenorphine injection | Drug | CAM2038 SC injections + SL placebo tabs |
| SL BPN/NX tabsAlso: Suboxone | Drug | SL BPN/NX tabs + placebo SC injections |
| placebo SC injectionsAlso: placebo | Drug | SL BPN/NX tabs + placebo SC injections |
| SL placebo tabletsAlso: placebo | Drug | CAM2038 SC injections + SL placebo tabs |
Primary outcome
Response Rate, Denoted by Response Rate (Weeks 1-24).
Time frame: 24 weeks
Response Rate, denoted by response rate (Weeks 1-24). A responder is defined as a subject with at least 33% of urine toxicology results collected during the Phase 1 (4 out of 12 urine samples) and 67% of urine toxicology results collected during Phase 2 (4 out of 6 urine samples) being negative for illicit opioids and self - reported illicit opioid use.
3 secondary outcomes
Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids
Time frame: 24 weeks
Number of Subjects With Sustained Abstinence of Opioid Use
Time frame: 24 weeks
Number of Subjects Remaining in the Study (Retention Rate)
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39629836Peterson S, Nunes EV, Lofwall MR, Walsh SL, Tiberg F. Exploring Opioid Use Disorder Outcomes by Quantitative Urinalysis: Post Hoc Analysis of a Phase 3 Randomized Clinical Trial. J Addict Med. 2025 May-Jun 01;19(3):260-267. doi: 10.1097/ADM.0000000000001405. Epub 2024 Dec 4.
- Derived from this study: PubMed 38916892Nunes EV, Comer SD, Lofwall MR, Walsh SL, Peterson S, Tiberg F, Hjelmstrom P, Budilovsky-Kelley NR. Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder With Fentanyl Use: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417377. doi: 10.1001/jamanetworkopen.2024.17377.
- Derived from this study: PubMed 29799968Lofwall MR, Walsh SL, Nunes EV, Bailey GL, Sigmon SC, Kampman KM, Frost M, Tiberg F, Linden M, Sheldon B, Oosman S, Peterson S, Chen M, Kim S. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jun 1;178(6):764-773. doi: 10.1001/jamainternmed.2018.1052.
- Individual participant dataSharing planned: No
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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.
Braeburn Pharmaceuticals study chair
Braeburn Pharmaceuticals
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CAM2038 SC injection and SL BPN/NX tabs in people with Opioid Use Disorders, run by Braeburn Pharmaceuticals at 36 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 7 inclusion and 14 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 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate, Denoted by Response Rate (Weeks 1-24). (time frame: 24 weeks). 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 NCT02651584, which also lists 3 linked publications.
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 22 Aug 2019.