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
Overview
- Phase
- Phase 3
- Intervention
- CAM2038 q1w or q4w exposure to SL BPN/NX
- Conditions
- Opioid Use Disorder
- Sponsor
- Braeburn Pharmaceuticals
- Enrollment
- 228
- Locations
- 32
- Primary Endpoint
- Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.
Detailed Description
Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up. Patients who are currently taking sublingual (SL) BPN (weekly or monthly prescription visits) or individuals who are actively seeking BPN treatment but who have not yet begun a treatment regimen, may be eligible for the study. Following Screening, qualified subjects meeting inclusion criteria and not meeting exclusion criteria will be initiated on either CAM2038 q1w or q4w, based on their current treatment status (qualified subjects currently on SL BPN or seeking BPN treatment). Qualified subjects will be initiated or transitioned to CAM2038 q1w or q4w as follows: Initiation of BPN treatment - initiate with CAM2038 q1w Currently receiving SL BPN treatments - transfer to corresponding CAM2038 q1w or q4w dose
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must provide written informed consent prior to the conduct of any study-related procedures.
- •Male or female, 18-65 years of age, inclusive.
- •Female subjects of childbearing potential must be willing to use a highly effective method of contraception during the entire study (Screening Visit to Follow-Up Visit).
- •Current diagnosis of moderate or severe opioid use disorder (DSM-V) or past medical history of opioid use disorder currently being treated with SL BPN.
- •Considered by the Investigator to be a good candidate for BPN treatment, based on medical and psychosocial history.
- •Subjects must meet one of the following criteria for BPN treatment history:
- •Voluntarily seeking treatment for opioid use disorder (not currently on BPN treatment for at least last 60 days but seeking BPN treatment), or;
- •Currently on SL BPN treatment.
Exclusion Criteria
- •Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).
- •Current diagnosis of chronic pain requiring opioids for treatment.
- •Current DSM-V diagnosis for moderate to severe substance use disorder (including alcohol) other than opioids, caffeine or nicotine and currently being treated as the primary substance use disorder.
- •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).
- •Pregnant or lactating or planning to become pregnant during the study.
- •Hypersensitivity or allergy to naloxone (only for subjects receiving the SL BPX test dose), BPN or excipients of CAM
- •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).
- •Hepatitis, unless under stable treatment, at the discretion of the Investigator.
- •Any pending legal action that could prohibit participation or compliance in the study.
- •Exposure to any investigational drug within the 4 weeks prior to Screening.
Arms & Interventions
CAM2038 q1w or q4w exposure to SL BPN/NX
CAM2038 (buprenorphine FluidCrystal®) Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w
Intervention: CAM2038 q1w or q4w exposure to SL BPN/NX
CAM2038 q1w or q4w new to BPN treatment
CAM2038 (buprenorphine FluidCrystal®) New to BPN Treatment who received CAM2038r q1w or q4w
Intervention: CAM2038 q1w or q4w new to BPN treatment
Outcomes
Primary Outcomes
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population
Time Frame: 12 months- 48 week
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Full Exposure Safety Population
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population
Time Frame: 12 months- 48 week
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population
Secondary Outcomes
- Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population)(12 months (48 weeks))
- Summary of Retention in Treatment (Efficacy Population)(48 weeks of treatment)
- Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)(12 months- 48 week)
- Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population)(12 months- 48 week)
- Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)(12 months (48 weeks))
- Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population)(12 months- 48 week)
- Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)(12 months- 48 week)