Moderate or Severe Opioid Use DisorderPhase 2NCT02611752

A Multiple Dose Opioid Challenge Study

A Phase 2 study testing CAM2038 in people with Moderate or Severe Opioid Use Disorder, run by Braeburn Pharmaceuticals at 3 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

Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in patients with moderate or severe opioid use disorder. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Moderate or Severe Opioid Use Disorder
What is being tested?: CAM2038
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 3 sitesUnited States
Study dates: Oct 2015to Apr 2016
Phase: Phase 2
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patient had to provide written informed consent prior to the conduct of any study-related procedures.
Male or female, 18-55 years of age, inclusive.
Patients with a diagnosis of moderate or severe opioid use disorder (DSM-V) who were physically dependent on intravenous (IV) or insufflated opioids, and who were willing to undergo short-term BPN treatment.
Self-reported opioid-use of a minimum of 21 days in the 30 days prior to Screening.
Positive UDS for opioids at Screening or at check-in. If UDS was not positive, patients had to present with physical signs of withdrawal, as determined by the Investigator. The Investigator may have administered a naloxone challenge, in order to confirm opioid dependence at the Investigator's discretion.
Female patients of childbearing potential had to be willing to use a reliable method of contraception during the entire study (Screening Visit to Follow-up Phone Call).

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Female patients of non-childbearing potential were surgically sterile (i.e., had undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels.
Male patients with female partners of childbearing potential had to agree to use a reliable method of contraception from Screening Visit through at least 3 months after the last dose of study drug. Male patients also must have agreed not to donate sperm during the study through at least 3 months after the last dose of study drug.
Were willing and able to comply with the study requirements (including blood sampling), complete study assessments, visit the clinic, and remain confined in the CRU for up to 25 consecutive days.

Who cannot join

History or presence of any clinically significant psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening, which in the opinion of the Investigator would have jeopardized the safety of the patient or the validity of the study results.
Opioid-dependent patients who were actively seeking treatment for their moderate to severe opioid use disorder.
Patients with positive UDS for BPN, barbiturates, or methadone or breath alcohol on the day of check-in to the CRU.
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 the upper limit of normal on the Screening laboratory assessments and at inpatient check-in, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may have prevented the patient from safely participating in study.
Any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead electrocardiogram ([ECG], QTcF ≥450 msec for males or ≥470 msec for females), and laboratory evaluation (including hematology, clinical chemistry, urinalysis, and serology [optional]) at Screening, in the opinion of the Investigator.
Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would have precluded compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may have prevented the patient from safely participating in study (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator's Brochure for CAM2038).

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Patients were carefully screened to exclude individuals presenting with a clinically significant history of seizure disorders, history of asthma or other respiratory disorders, head injury, hypertension, or personal history of cardiovascular disease or clinically significant ECG abnormalities.
Current diagnosis of Acquired Immune Deficiency Syndrome.
Current diagnosis of chronic pain requiring opioids for treatment.
Patients who met the criteria for a diagnosis of moderate or severe substance use disorder according to DSM-V criteria for any other substances other than opioids, caffeine, or tobacco.
Pregnant or lactating, or planned to become pregnant during the study.
Clinically significant history of or current evidence of suicidal ideation or active suicidal behavior as based on the Columbia-Suicide Severity Rating Scale (C-SSRS; grade 4 or 5).
Hypersensitivity or allergy to BPN or other opioids or excipients of CAM2038.
Intolerance to venipuncture and/or difficulty with venous access, as per the judgment of the Investigator/research staff.
Patient was using an investigational drug or monoamine oxidase inhibitor or had used such within the last 30 days (or 5 times the half-life of the drug, if known and longer) prior to first drug administration in the Qualification Phase (i.e., IR morphine sulfate).
Required current use of agents that were 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).
If the patient was currently on probation or had any pending legal action that could have prohibited participation or compliance in the study.
A patient who, in the opinion of the Investigator, was considered unsuitable or unlikely to comply with the study protocol for any reason.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Kentucky
Lexington, Kentucky, 40513
New York Psychiatric Institute
New York, New York, 10032
Vince and Associates Clinical Research
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Multiple Dose Opioid Challenge Study to Assess Blockade of Subjective Opioid Effects of CAM2038 q1w (Buprenorphine FluidCrystal® Subcutaneous Injection Depots) In Adults With Opioid Use Disorder

Read the detailed description

This is a multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and duration of action of multiple doses of CAM2038 q1w in blocking the effects of a mu opioid agonist (hydromorphone) in patients with moderate or severe opioid use disorder. The study will involve 4 phases: Screening, Qualification, Treatment, and Follow-up.

The study will enroll a sufficient number of subjects to ensure that at least 48 subjects complete the study (24 subjects per group with at least 16 females in total). Replacement subjects may be added at the discretion of the sponsor with the agreement of the investigator.

Conditions: Moderate or Severe Opioid Use Disorder
Being tested: CAM2038
Medical subject headings: Lymphoma, Follicular, Opioid-Related Disorders

What participants receive

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

CAM2038Drug
CAM2038 subcutaneous injection

Study groups in NCT02611752
Study group	Role	What they receive
CAM2038 q1w, 24 mg	Experimental	CAM2038 q1w 24 mg will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13 Receives: Drug: CAM2038
CAM2038 q1w, 32 mg	Experimental	CAM2038 q1w 32 mg will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13 Receives: Drug: CAM2038

What is being measured

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

Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg
Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Measured: 17 days
Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg
Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population), where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Measured: 17 days
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Measured: 17 days
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 32 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Measured: 17 days

Secondary outcomes (7)

Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I feel high" where values can range from 0 (Not at all High) to 100 (Extremely High).
Measured: 15 days
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseling and four challenge sequences with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I feel good drug effects" where values can range from 0 (Not at all ) to 100 (Extremely).
Measured: 15 days
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I feel bad effects" where values can range from 0 (Not at all) to 100 (Extremely).
Measured: 15 days
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I feel bad effects" where values can range from 0 (Not at all) to 100 (Extremely).
Measured: 15 days
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Analysis Results for Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I desire opiods" where values can range from 0 (Definitely not) to 100 (Definitely so).
Measured: 15 days
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, my mental state is" where values can range from 0 (Very Drowsy) to 100 (Very alert), with 50 being neutral (Neither drowsy nor alert).
Measured: 15 days
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I fell any drug effects" where values can range from 0 (Not at all) to 100 (Extremely).
Measured: 15 days

Timeline

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

Oct 2015Apr 2016

First posted23 Nov 2015 (estimated)
Study startOct 2015
Primary completionApr 2016
Study completionApr 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 (2)Papers the sponsor has linked to this study.
Other trials for Moderate or 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02611752
Sponsor's protocol ID: HS-13-478
Status last verified: Aug 2018
First submitted: 18 Nov 2015
Last updated: 14 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bjornsson M, Acharya C, Strandgarden K, Tiberg F. Population Pharmacokinetic Analysis Supports Initiation Treatment and Bridging from Sublingual Buprenorphine to Subcutaneous Administration of a Buprenorphine Depot (CAM2038) in the Treatment of Opioid Use Disorder. Clin Pharmacokinet. 2023 Oct;62(10):1427-1443. doi: 10.1007/s40262-023-01288-6. Epub 2023 Aug 16.
PubMed 37584841
Walsh SL, Comer SD, Lofwall MR, Vince B, Levy-Cooperman N, Kelsh D, Coe MA, Jones JD, Nuzzo PA, Tiberg F, Sheldon B, Kim S. Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):894-902. doi: 10.1001/jamapsychiatry.2017.1874.
PubMed 28655025

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?

See locations

Recruiting
Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses
Opioid Use Disorder, Opioid Use Disorder, Severe
Enrolling by invitation
TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following Hospitalization
Opioid Use Disorder, Opioid Use Disorder, Moderate
RecruitingPhase 2
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Opioid Use Disorder, Opioid Use Disorder, Moderate
Not yet recruiting
Family-Focused Study to Support Medication for Opioid Use Disorder
Opioid Use Disorder, Opioid Use Disorder, Moderate
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe

All Moderate or Severe Opioid Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Dose Opioid Challenge Study to Assess Blockade of Subjective Opioid Effects of CAM2038 q1w (Buprenorphine FluidCrystal® Subcutaneous Injection Depots) In Adults With Opioid Use Disorder
ClinicalTrials.gov ID: NCT02611752
Acronym / sponsor ID: HS-13-478
Conditions: Moderate or Severe Opioid Use Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Braeburn PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 23 Nov 2015 (estimated)
Results: Posted 14 Nov 2019

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
CAM2038 q1w, 24 mg	Experimental	Drug: CAM2038CAM2038 q1w 24 mg will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13
CAM2038 q1w, 32 mg	Experimental	Drug: CAM2038CAM2038 q1w 32 mg will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Patient had to provide written informed consent prior to the conduct of any study-related procedures.
Male or female, 18-55 years of age, inclusive.
Patients with a diagnosis of moderate or severe opioid use disorder (DSM-V) who were physically dependent on intravenous (IV) or insufflated opioids, and who were willing to undergo short-term BPN treatment.
Self-reported opioid-use of a minimum of 21 days in the 30 days prior to Screening.
Positive UDS for opioids at Screening or at check-in. If UDS was not positive, patients had to present with physical signs of withdrawal, as determined by the Investigator. The Investigator may have administered a naloxone challenge, in order to confirm opioid dependence at the Investigator's discretion.

Key exclusion criteria (18 listed)

History or presence of any clinically significant psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening, which in the opinion of the Investigator would have jeopardized the safety of the patient or the validity of the study results.
Opioid-dependent patients who were actively seeking treatment for their moderate to severe opioid use disorder.
Patients with positive UDS for BPN, barbiturates, or methadone or breath alcohol on the day of check-in to the CRU.
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 the upper limit of normal on the Screening laboratory assessments and at inpatient check-in, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may have prevented the patient from safely participating in study.
Any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead electrocardiogram ([ECG], QTcF ≥450 msec for males or ≥470 msec for females), and laboratory evaluation (including hematology, clinical chemistry, urinalysis, and serology [optional]) at Screening, in the opinion of the Investigator.

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
CAM2038CAM2038 subcutaneous injection	Drug	CAM2038 q1w, 24 mg, CAM2038 q1w, 32 mg

Primary outcome

Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg
Time frame: 17 days
Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg
Time frame: 17 days
Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population), where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg
Time frame: 17 days
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg
Time frame: 17 days
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 32 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.

7 secondary outcomes

Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Time frame: 15 days
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Time frame: 15 days
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)
Time frame: 15 days
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)
Time frame: 15 days
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Time frame: 15 days
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Time frame: 15 days
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Time frame: 15 days

Results and safety

Results posted to the registry on 14 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CAM2038 q1w, 24 mg	22	22
CAM2038 q1w, 32 mg	25	24

Primary outcome: Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg

Time frame: 17 days. Least squares mean (Standard Error). Unit: units on a scale

Measure	CAM2038 q1w, 24 mg - Hydromorphone 0 mg n = 22	CAM2038 q1w, 24 mg - Hydromorphone 6 mg n = 22	CAM2038 q1w, 24 mg - Hydromorphone 18 mg n = 22
Baseline	50.6 (1.48)	83.2 (1.48)	92.7 (1.48)
Days 1-3	51.3 (0.84)	52.2 (0.84)	53.1 (0.84)
Days 4-6	50.8 (0.84)	52.1 (0.84)	58.3 (0.84)
Days 8 -10	51.1 (0.84)	52.6 (0.84)	52.9 (0.84)
Days 11-13	51.0 (0.84)	51.9 (0.84)	54.6 (0.84)

Population analysed: Mean Drug Liking VAS Scores over Time for CAM2038 q1w 24 mg by Hydromorphone Challenge Session, Completer Population (N=22)

Primary outcome: Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg

Time frame: 17 days. Least squares mean (Standard Error). Unit: units on a scale

Measure	CAM2038 q1w, 32 mg - Hydromorphone 0 mg n = 24	CAM2038 q1w, 32 mg - Hydromorphone 6 mg n = 24	CAM2038 q1w, 32 mg - Hydromorphone 18 mg n = 24
Baseline	52.9 (1.70)	79.6 (1.70)	93.2 (1.70)
Days 1-3	51.6 (1.01)	52.5 (1.01)	54.0 (1.01)
Days 4-6	51.5 (1.01)	53.0 (1.01)	56.0 (1.01)
Days 8 -10	51.7 (1.01)	52.3 (1.01)	54.2 (1.01)
Days 11-13	51.2 (1.01)	52.1 (1.01)	54.8 (1.01)

Population analysed: Mean Drug Liking VAS Scores over Time for CAM2038 q1w 32 mg by Hydromorphone Challenge Session, Completer Population (N=24)

Primary outcome: Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg

Time frame: 17 days. Least squares mean (Standard Error). Unit: units on a scale

Measure	CAM2038 q1w, 24 mg - Hydromorphone 6 Mg-Hydromorphone 0 mg n = 22	CAM2038 q1w, 24 mg - Hydromorphone 18 mg- Hydromorphone 0mg n = 22	CAM2038 q1w, 24 mg - Hydromorphone 18 mg- Hydromorphone 6 mg n = 22
Qualification/Baseline	32.7 (1.90)	42.1 (1.90)	9.5 (1.90)
Days 1-3	0.9 (1.12)	1.8 (1.12)	0.9 (1.12)
Days 4-6	1.3 (1.12)	7.4 (1.12)	6.2 (1.12)
Days 8 -10	1.5 (1.12)	1.8 (1.12)	0.3 (1.12)
Days 11-13	0.9 (1.12)	3.6 (1.12)	2.7 (1.12)

Population analysed: Mean Drug Liking VAS Scores over Time for CAM2038 q1w 24 mg by Hydromorphone Challenge Session, Completer Population (N=22)

Primary outcome: Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg

Time frame: 17 days. Least squares mean (Standard Error). Unit: units on a scale

Measure	CAM2038 q1w, 32 mg - Hydromorphone 6 Mg-Hydromorphone 0 mg n = 24	CAM2038 q1w, 32 mg - Hydromorphone 18 mg- Hydromorphone 0mg n = 24	CAM2038 q1w, 32 mg - Hydromorphone 18 mg- Hydromorphone 6 mg n = 24
Qualification/Baseline	26.7 (2.40)	40.3 (2.40)	13.7 (2.40)
Days 1-3	0.9 (1.05)	2.4 (1.05)	1.5 (1.05)
Days 4-6	1.5 (1.05)	4.5 (1.05)	3.0 (1.05)
Days 8 -10	0.5 (1.05)	2.5 (1.05)	2.0 (1.05)
Days 11-13	1.0 (1.05)	3.6 (1.05)	2.6 (1.05)

Population analysed: Mean Drug Liking VAS Scores over Time for CAM2038 q1w 32 mg by Hydromorphone Challenge Session, Completer Population (N=24)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CAM2038 q1w, 24 mg	0 of 22 (0%)	13 of 22 (59.1%)	0 of 22
CAM2038 q1w, 32 mg	0 of 25 (0%)	24 of 25 (96%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37584841Bjornsson M, Acharya C, Strandgarden K, Tiberg F. Population Pharmacokinetic Analysis Supports Initiation Treatment and Bridging from Sublingual Buprenorphine to Subcutaneous Administration of a Buprenorphine Depot (CAM2038) in the Treatment of Opioid Use Disorder. Clin Pharmacokinet. 2023 Oct;62(10):1427-1443. doi: 10.1007/s40262-023-01288-6. Epub 2023 Aug 16.
Derived from this study: PubMed 28655025Walsh SL, Comer SD, Lofwall MR, Vince B, Levy-Cooperman N, Kelsh D, Coe MA, Jones JD, Nuzzo PA, Tiberg F, Sheldon B, Kim S. Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):894-902. doi: 10.1001/jamapsychiatry.2017.1874.

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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.

Sharon Walsh, PhD principal investigator

University of Kentucky

3 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 CAM2038 in people with Moderate or Severe Opioid Use Disorder, run by Braeburn Pharmaceuticals at 3 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 9 inclusion and 18 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 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 14 Nov 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?

Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg (time frame: 17 days). The study lists 4 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 NCT02611752, which also lists 2 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 14 Nov 2019; AzTrials last refreshed its copy on 27 Oct 2026.