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

NCT02672111 | Completed Phase 3 Results

• 1 other identifier: HS-14-499
• Study Type: interventional
• Target: 228
• Locations: 8 countries
• Sites: 32

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population

  Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population

  12 months- 48 week

• Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population

  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

  12 months- 48 week

Secondary Outcomes (7)

• Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)

  12 months (48 weeks)

• 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 Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population)

  12 months- 48 week

• Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population)

  12 months- 48 week

Study Arms (2)

CAM2038 q1w or q4w exposure to SL BPN/NX

EXPERIMENTAL

CAM2038 (buprenorphine FluidCrystal®) Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w

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

CAM2038 q1w or q4w new to BPN treatment

EXPERIMENTAL

CAM2038 (buprenorphine FluidCrystal®) New to BPN Treatment who received CAM2038r q1w or q4w

Drug: CAM2038 q1w or q4w new to BPN treatment

Interventions

CAM2038 q1w or q4w exposure to SL BPN/NX DRUG

Also known as: Buprenorphine injection

CAM2038 q1w or q4w exposure to SL BPN/NX

CAM2038 q1w or q4w new to BPN treatment DRUG

Also known as: Buprenorphine injection

CAM2038 q1w or q4w new to BPN treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braeburn Pharmaceuticals: lead

Study Sites (32)

Parkway Medical Center

Birmingham, Alabama, 35215, United States

Location

Haleyville Clinical Research LLC

Haleyville, Alabama, 35565, United States

Location

Boyett Health Services Inc

Hamilton, Alabama, 35570, United States

Location

Dr Vijapura and Associates

Jacksonville, Florida, 32256, United States

Location

TRY Research

Maitland, Florida, 32751, United States

Location

Stanley Street Treatment and Resources Inc

Fall River, Massachusetts, 02720, United States

Location

Wellness and Research Center

Belvidere, New Jersey, 07823, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

STARS/Columbia University

New York, New York, 10019, United States

Location

Frost Medical Group, LLC

Conshohocken, Pennsylvania, 19428, United States

Location

Newcastle Community Health Services

Newcastle, NSW 2300, Australia

Location

Drug & Alcohol Services SA Drug and Alcohol Services

Norwood, 5070, Australia

Location

Royal Prince Alfred Hospital

Sydney, 2050, Australia

Location

South Eastern Sydney Local Health District (SESLHD)

Sydney, NSW 2010, Australia

Location

Center for Misbrugsbehandling

Aarhus, 8000, Denmark

Location

Behandlingscenter Odense

Odense, 5000, Denmark

Location

Gemeinschaftspraxis Schnaitmann/Schaffert Salzstrasse

Heilbronn, 74076, Germany

Location

Studikum - Zentrum fur Klinische Studien im Praxiszentrum Friedrichsplatz

Kassel, 34117, Germany

Location

Klinik fur Abhangiges Verhalten und Suchtmedizin Zentralinstitut

Mannheim, 68159, Germany

Location

Psychosoziale Begleitung - Praxis Boniakowski

Regensburg, 93051, Germany

Location

Praxisgemeinschaft

Stuttgart, 70197, Germany

Location

Clinexpert Kft

Budapest, 1033, Hungary

Location

XVI. Kerület Kertvárosi Egészségügyi Szolgálata, Addiktológia

Budapest, 1165, Hungary

Location

Metadonsektionen

Stockholm, 118 67, Sweden

Location

Centrallasarettet Vasteras

Västerås, 72189, Sweden

Location

Jinan Psychiatric Center, Ministry of Health and Welfa

Tainan, Tainan County, 717, Taiwan

Location

China Medical University Hospita

Taichung, 40447, Taiwan

Location

Taipei City Hospital

Taipei, 103, Taiwan

Location

Blackberry Centre Blackberry Hill Hospital

Fishponds, Bristol, BS16 2EW, United Kingdom

Location

Hellesdon Hospital The Weavers Centre

Hellesdon, Norwich, NR6 5BE, United Kingdom

Location

NHS Tayside

Dundee, DD1 9SY, United Kingdom

Location

Lambeth Drug and Alcohol Service Lorraine Hewitt House

London, SW9 8DG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31013390 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Sonnie Kim
• Organization: Braeburn

sonnie@braeburnrx.com

1 610 467 8717

Study Officials

• Michael Frost, MD

  Frost Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: February 3, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 15, 2020
• Results First Posted: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); DK (2); TW (3); GB (4); US (10); DE (5); HU (2); SE (2)