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

NCT ID: NCT02672111

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-05-31

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

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CAM2038 q1w or q4w exposure to SL BPN/NX

Intervention Type: DRUG

CAM2038 q1w or q4w new to BPN treatment

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

Group Type: EXPERIMENTAL

CAM2038 q1w or q4w new to BPN treatment

Intervention Type: DRUG

Interventions

CAM2038 q1w or q4w exposure to SL BPN/NX

Intervention Type: DRUG

CAM2038 q1w or q4w new to BPN treatment

Intervention Type: DRUG

Other Intervention Names

Buprenorphine injection; Buprenorphine injection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braeburn Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Frost, MD

Role: PRINCIPAL_INVESTIGATOR

Frost Medical Group

Locations

Parkway Medical Center

Birmingham, Alabama, United States

Haleyville Clinical Research LLC

Haleyville, Alabama, United States

Boyett Health Services Inc

Hamilton, Alabama, United States

Dr Vijapura and Associates

Jacksonville, Florida, United States

TRY Research

Maitland, Florida, United States

Stanley Street Treatment and Resources Inc

Fall River, Massachusetts, United States

Wellness and Research Center

Belvidere, New Jersey, United States

Comprehensive Clinical Research

Berlin, New Jersey, 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

Psychosoziale Begleitung - Praxis Boniakowski

Regensburg, , Germany

Praxisgemeinschaft

Stuttgart, , Germany

Clinexpert Kft

Budapest, , Hungary

XVI. Kerület Kertvárosi Egészségügyi Szolgálata, Addiktológia

Budapest, , Hungary

Metadonsektionen

Stockholm, , Sweden

Centrallasarettet Vasteras

Västerås, , Sweden

Jinan Psychiatric Center, Ministry of Health and Welfa

Tainan City, Tainan County, Taiwan

China Medical University Hospita

Taichung, , Taiwan

Taipei City Hospital

Taipei, , Taiwan

Blackberry Centre Blackberry Hill Hospital

Fishponds, Bristol, United Kingdom

Hellesdon Hospital The Weavers Centre

Hellesdon, Norwich, United Kingdom

NHS Tayside

Dundee, , United Kingdom

Lambeth Drug and Alcohol Service Lorraine Hewitt House

London, , United Kingdom

Countries

United States; Australia; Denmark; Germany; Hungary; Sweden; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31013390 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

HS-14-499

Identifier Type: -

Identifier Source: org_study_id