Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder

Phase 3

Completed

Conditions: Opioid Use Disorder

Interventions: Drug: CAM2038 q1w or q4w exposure to SL BPN/NX
Drug: CAM2038 q1w or q4w new to BPN treatment

Registration Number: NCT02672111

Lead Sponsor: Braeburn Pharmaceuticals

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 228

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 CAM2038.
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.
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.
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.
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. This includes, but is not limited to, subjects with attention deficit hyperactivity disorder receiving central stimulants (e.g. methylphenidate or other central stimulants), as well as subjects with severe respiratory insufficiency, respiratory depression, airway obstruction, gastrointestinal motility disorders, severe hepatic insufficiency, planned surgery and prior treatment with monoamine oxidase inhibitors.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAM2038 q1w or q4w exposure to SL BPN/NX	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
CAM2038 q1w or q4w new to BPN treatment	CAM2038 q1w or q4w new to BPN treatment	CAM2038 (buprenorphine FluidCrystal®) New to BPN Treatment who received CAM2038r q1w or q4w

Primary Outcome Measures

Name	Time	Method
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population	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	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 Outcome Measures

Name	Time	Method
Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population)	12 months (48 weeks)	The following is a summary of Mean Percentage of Self-Reported No Illicit Opioid Use during the entire study (Efficacy Population). The proportion of patients who reported no illicit opioid use during the study was analyzed. For example if a subject provided 10 self reports and 2 out of the 10 were "Used", the percentage for the subject would be 20%. The average percentage of all patients is provided.
Summary of Retention in Treatment (Efficacy Population)	48 weeks of treatment	The following is a summary of treatment retention over 48 weeks
Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)	12 months- 48 week	The following table summarizes the desire to use measurements over a period of 12 months - 48 weeks. Desire to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked "Since your last scheduled assessment visit, indicate your worst or strongest desire to use opioids, where 0 = No desire to use and 100 mm = Strongest possible desire.
Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population)	12 months- 48 week	A summary of COWS (administered by the Clinician) over 48 weeks to show withdrawal symptoms from baseline to end of treatment. This scale consists of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale from 0 to 4 or 5 and based on a timed period of observation of the subject by the rater. Higher scores are associated with greater withdrawal symptoms with a total range for all items of between 0-48
Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)	12 months (48 weeks)	The following is a summary of Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)
Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population)	12 months- 48 week	Summary of SOWS over time to show withdrawal symtons, from baseline to end of treatment. This form contains 16 questions that rate the intensity of withdrawal from 0 ("Not at all") to 4 ("Extremely"), with higher scores associated with greater withdrawal symptoms and total range for all items of 0-64
Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)	12 months- 48 week	The following results summarize the need to use VAS over a period of 12 months - 48 weeks. Need to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked "Since your last scheduled assessment visit, indicate your worst or strongest need to use opioids, where 0 = No need to use and 100 mm = Strongest possible need.

Trial Locations

Locations (32): Boyett Health Services Inc
🇺🇸
Hamilton, Alabama, United States
Dr Vijapura and Associates
🇺🇸
Jacksonville, Florida, United States
Haleyville Clinical Research LLC
🇺🇸
Haleyville, Alabama, United States
Stanley Street Treatment and Resources Inc
🇺🇸
Fall River, Massachusetts, United States
TRY Research
🇺🇸
Maitland, Florida, United States
STARS/Columbia University
🇺🇸
New York, New York, United States
Frost Medical Group, LLC
🇺🇸
Conshohocken, Pennsylvania, United States
Newcastle Community Health Services
🇦🇺
Newcastle, Australia
Drug & Alcohol Services SA Drug and Alcohol Services
🇦🇺
Norwood, Australia
Royal Prince Alfred Hospital
🇦🇺
Sydney, Australia
South Eastern Sydney Local Health District (SESLHD)
🇦🇺
Sydney, Australia
Center for Misbrugsbehandling
🇩🇰
Aarhus, Denmark
Behandlingscenter Odense
🇩🇰
Odense, Denmark
Gemeinschaftspraxis Schnaitmann/Schaffert Salzstrasse
🇩🇪
Heilbronn, Germany
Studikum - Zentrum fur Klinische Studien im Praxiszentrum Friedrichsplatz
🇩🇪
Kassel, Germany
Klinik fur Abhangiges Verhalten und Suchtmedizin Zentralinstitut
🇩🇪
Mannheim, Germany
Praxisgemeinschaft
🇩🇪
Stuttgart, Germany
Psychosoziale Begleitung - Praxis Boniakowski
🇩🇪
Regensburg, Germany
Centrallasarettet Vasteras
🇸🇪
Västerås, Sweden
Metadonsektionen
🇸🇪
Stockholm, Sweden
Blackberry Centre Blackberry Hill Hospital
🇬🇧
Fishponds, Bristol, United Kingdom
Hellesdon Hospital The Weavers Centre
🇬🇧
Hellesdon, Norwich, United Kingdom
Lambeth Drug and Alcohol Service Lorraine Hewitt House
🇬🇧
London, United Kingdom
Parkway Medical Center
🇺🇸
Birmingham, Alabama, United States
Wellness and Research Center
🇺🇸
Belvidere, New Jersey, United States
China Medical University Hospita
🇨🇳
Taichung, Taiwan
Comprehensive Clinical Research
🇺🇸
Berlin, New Jersey, United States
Clinexpert Kft
🇭🇺
Budapest, Hungary
XVI. Kerület Kertvárosi Egészségügyi Szolgálata, Addiktológia
🇭🇺
Budapest, Hungary
Jinan Psychiatric Center, Ministry of Health and Welfa
🇨🇳
Tainan, Tainan County, Taiwan
Taipei City Hospital
🇨🇳
Taipei, Taiwan
NHS Tayside
🇬🇧
Dundee, United Kingdom