Clinical Trials List
Protocol NumberHS-14-499
2015-12-01 - 2017-12-31
Phase III
Terminated3
An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients with Opioid Use Disorder.
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Trial Applicant
MEDPACE TAIWAN LIMITED
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Sponsor
Braeburn Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 鄭婉汝 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
opioid use disorder
Objectives
Primary Objective:
To demonstrate the safety and tolerability of CAM2038 products in 12-month (48-week) buprenorphine (BPN) treatment in adult outpatients with opioid use disorder.
Secondary Objectives:
To evaluate efficacy of CAM2038 through several efficacy parameters, including urine toxicology, signs and symptoms of withdrawal and cravings in adult outpatients with opioid use disorder.
Test Drug
CAM2038 q1w（buprenorphine FluidCrystal®每週一次長效注射劑）; CAM2038 q4w（buprenorphine FluidCrystal®每月一次長效注射劑）
Active Ingredient
buprenorphine
Dosage Form
injection
Dosage
q1w: 50mg/mL
q4w: 356 mg/mL
q4w: 356 mg/mL
Endpoints
Safety Endpoints:
- Adverse events (AEs) and serious adverse events (SAEs)
- Clinical laboratory tests
- Electrocardiogram (ECG)
- Vital signs
- Physical and injection site examinations
- Concomitant medications
Efficacy Measures:
- Urine toxicology results for illicit opioids
- Self-reported illicit opioid use
- Retention (%) in treatment
- Measures of opioid withdrawal:
- Clinical Opiate Withdrawal Scale (COWS)
- Subjective Opiate Withdrawal Scale (SOWS)
- Measures of opioid craving:
- Desire to Use visual analogue scale (VAS)
- Need to Use VAS
- Urine toxicology results for other drugs of abuse
- Adverse events (AEs) and serious adverse events (SAEs)
- Clinical laboratory tests
- Electrocardiogram (ECG)
- Vital signs
- Physical and injection site examinations
- Concomitant medications
Efficacy Measures:
- Urine toxicology results for illicit opioids
- Self-reported illicit opioid use
- Retention (%) in treatment
- Measures of opioid withdrawal:
- Clinical Opiate Withdrawal Scale (COWS)
- Subjective Opiate Withdrawal Scale (SOWS)
- Measures of opioid craving:
- Desire to Use visual analogue scale (VAS)
- Need to Use VAS
- Urine toxicology results for other drugs of abuse
Inclution Criteria
Inclusion Criteria:
Subjects must meet each one of the following inclusion criteria in order to be eligible for
participation in the study:
1. Subject must provide written informed consent prior to the conduct of any study-related
procedures.
2. Male or female, 20-65 years of age, inclusive.
3. Female subjects of childbearing potential must be willing to use a reliable method of
contraception during the entire study (Screening Visit to Follow-Up Visit) (Section 9.1.6).
4. Diagnosis of moderate or severe opioid use disorder (DSM-V)
5. Considered by the Investigator to be a good candidate for BPN treatment, based on
medical and psychosocial history.
6. Subjects must meet one of the following criteria for BPN treatment history:
a. Voluntarily seeking treatment for opioid use disorder (not currently on BPN
treatment but seeking BPN treatment), or;
b. Currently on SL BPN treatment.
Subjects must meet each one of the following inclusion criteria in order to be eligible for
participation in the study:
1. Subject must provide written informed consent prior to the conduct of any study-related
procedures.
2. Male or female, 20-65 years of age, inclusive.
3. Female subjects of childbearing potential must be willing to use a reliable method of
contraception during the entire study (Screening Visit to Follow-Up Visit) (Section 9.1.6).
4. Diagnosis of moderate or severe opioid use disorder (DSM-V)
5. Considered by the Investigator to be a good candidate for BPN treatment, based on
medical and psychosocial history.
6. Subjects must meet one of the following criteria for BPN treatment history:
a. Voluntarily seeking treatment for opioid use disorder (not currently on BPN
treatment but seeking BPN treatment), or;
b. Currently on SL BPN treatment.
Exclusion Criteria
Exclusion Criteria
Subjects will not be eligible to participate in this study if any one of the following exclusion
criteria is met:
1. Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).
2. Current diagnosis of chronic pain requiring opioids for treatment.
3. Current DSM-V diagnosis for moderate to severe substance use disorder on any other
psychoactive substances other than opioids, caffeine or nicotine and currently being
treated as the primary substance use disorder.
4. Pregnant or lactating or planning to become pregnant during the study.
5. Hypersensitivity or allergy to BPN or excipients of CAM2038.
6. Requires chronic use of agents that are strong inhibitors or inducers of cytochrome
P450 3A4 (CYP 3A4) such as some azole antifungals (e.g., ketoconazole), macrolide
antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and
saquinavir).
7. Active hepatitis. Subjects with no significant viral load, no acute signs of inflammation,
and no clinical necessity for therapy will be allowed, at the discretion of the Investigator.
8. Any pending legal action that could prohibit participation or compliance in the study.
9. Exposure to any investigational drug within the 4 weeks prior to Screening.
10. 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
study.
11. Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure,
hypokalemia, family history of Long QT Syndrome) or an ECG demonstrating a Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF > 470 in females at screening.
12. . Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the subject from safely participating in study.
13. Is an employee of the Investigator or the trial site, with direct involvement in the
proposed trial or other studies under the direction of the Investigator or trial site, or is a
family member of an employee or of the Investigator.
Subjects will not be eligible to participate in this study if any one of the following exclusion
criteria is met:
1. Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).
2. Current diagnosis of chronic pain requiring opioids for treatment.
3. Current DSM-V diagnosis for moderate to severe substance use disorder on any other
psychoactive substances other than opioids, caffeine or nicotine and currently being
treated as the primary substance use disorder.
4. Pregnant or lactating or planning to become pregnant during the study.
5. Hypersensitivity or allergy to BPN or excipients of CAM2038.
6. Requires chronic use of agents that are strong inhibitors or inducers of cytochrome
P450 3A4 (CYP 3A4) such as some azole antifungals (e.g., ketoconazole), macrolide
antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and
saquinavir).
7. Active hepatitis. Subjects with no significant viral load, no acute signs of inflammation,
and no clinical necessity for therapy will be allowed, at the discretion of the Investigator.
8. Any pending legal action that could prohibit participation or compliance in the study.
9. Exposure to any investigational drug within the 4 weeks prior to Screening.
10. 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
study.
11. Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure,
hypokalemia, family history of Long QT Syndrome) or an ECG demonstrating a Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF > 470 in females at screening.
12. . Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the subject from safely participating in study.
13. Is an employee of the Investigator or the trial site, with direct involvement in the
proposed trial or other studies under the direction of the Investigator or trial site, or is a
family member of an employee or of the Investigator.
The Estimated Number of Participants
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Taiwan
16 participants
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Global
228 participants
