Clinical trial NCT02672111: Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Use Disorder
Lead sponsor: Braeburn Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-02-03
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Subject must provide written informed consent prior to the conduct of any study-related procedures.
2. Male or female, 18-65 years of age, inclusive.
3. 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).
4. 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.
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:

   * 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:

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 (including alcohol) other than opioids, caffeine or nicotine and currently being treated as the primary substance use disorder.
4. 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).
5. Pregnant or lactating or planning to become pregnant during the study.
6. Hypersensitivity or allergy to naloxone (only for subjects receiving the SL BPX test dose), BPN or excipients of CAM2038.
7. 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).
8. Hepatitis, unless under stable treatment, at the discretion of the Investigator.
9. Any pending legal action that could prohibit participation or compliance in the study.
10. Exposure to any investigational drug within the 4 weeks prior to Screening.
11. 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.
12. 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.
13. 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.
14. 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.

Primary outcomes:
measure: Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population
timeFrame: 12 months- 48 week
measure: Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population
timeFrame: 12 months- 48 week
Secondary outcomes:
measure: Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)
timeFrame: 12 months (48 weeks)
measure: Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population)
timeFrame: 12 months (48 weeks)
measure: Summary of Retention in Treatment (Efficacy Population)
timeFrame: 48 weeks of treatment
measure: Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population)
timeFrame: 12 months- 48 week
measure: Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population)
timeFrame: 12 months- 48 week
measure: Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)
timeFrame: 12 months- 48 week
measure: Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)
timeFrame: 12 months- 48 week
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Haleyville
country: United States
facility: Haleyville Clinical Research LLC
state: Alabama
city: Hamilton
country: United States
facility: Boyett Health Services Inc
state: Alabama
city: Jacksonville
country: United States
facility: Dr Vijapura and Associates
state: Florida
city: Maitland
country: United States
facility: TRY Research
state: Florida
city: Fall River
country: United States
facility: Stanley Street Treatment and Resources Inc
state: Massachusetts
city: Belvidere
country: United States
facility: Wellness and Research Center
state: New Jersey
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: New York
country: United States
facility: STARS/Columbia University
state: New York
city: Conshohocken
country: United States
facility: Frost Medical Group, LLC
state: Pennsylvania
city: Newcastle
country: Australia
facility: Newcastle Community Health Services
city: Norwood
country: Australia
facility: Drug & Alcohol Services SA Drug and Alcohol Services
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
city: Sydney
country: Australia
facility: South Eastern Sydney Local Health District (SESLHD)
city: Aarhus
country: Denmark
facility: Center for Misbrugsbehandling
city: Odense
country: Denmark
facility: Behandlingscenter Odense
city: Heilbronn
country: Germany
facility: Gemeinschaftspraxis Schnaitmann/Schaffert Salzstrasse
city: Kassel
country: Germany
facility: Studikum - Zentrum fur Klinische Studien im Praxiszentrum Friedrichsplatz
city: Mannheim
country: Germany
facility: Klinik fur Abhangiges Verhalten und Suchtmedizin Zentralinstitut
city: Regensburg
country: Germany
facility: Psychosoziale Begleitung - Praxis Boniakowski
city: Stuttgart
country: Germany
facility: Praxisgemeinschaft
city: Budapest
country: Hungary
facility: Clinexpert Kft
city: Budapest
country: Hungary
facility: XVI. Kerület Kertvárosi Egészségügyi Szolgálata, Addiktológia
city: Stockholm
country: Sweden
facility: Metadonsektionen
city: Västerås
country: Sweden
facility: Centrallasarettet Vasteras
city: Tainan
country: Taiwan
facility: Jinan Psychiatric Center, Ministry of Health and Welfa
state: Tainan County
city: Taichung
country: Taiwan
facility: China Medical University Hospita
city: Taipei
country: Taiwan
facility: Taipei City Hospital
city: Fishponds
country: United Kingdom
facility: Blackberry Centre Blackberry Hill Hospital
state: Bristol
city: Hellesdon
country: United Kingdom
facility: Hellesdon Hospital The Weavers Centre
state: Norwich
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: London
country: United Kingdom
facility: Lambeth Drug and Alcohol Service Lorraine Hewitt House
Study officials:
affiliation: Frost Medical Group
name: Michael Frost, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frost M, Bailey GL, Lintzeris N, Strang J, Dunlop A, Nunes EV, Jansen JB, Frey LC, Weber B, Haber P, Oosman S, Kim S, Tiberg F. Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder. Addiction. 2019 Aug;114(8):1416-1426. doi: 10.1111/add.14636. Epub 2019 Jun 3.