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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02672111




Registration number
NCT02672111
Ethics application status
Date submitted
15/01/2016
Date registered
3/02/2016

Titles & IDs
Public title
Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder
Scientific 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
Secondary ID [1] 0 0
HS-14-499
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid Use Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 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

Experimental: CAM2038 q1w or q4w new to BPN treatment - CAM2038 (buprenorphine FluidCrystal®) New to BPN Treatment who received CAM2038r q1w or q4w
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population
Timepoint [1] 0 0
12 months- 48 week
Primary outcome [2] 0 0
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population
Timepoint [2] 0 0
12 months- 48 week
Secondary outcome [1] 0 0
Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)
Timepoint [1] 0 0
12 months (48 weeks)
Secondary outcome [2] 0 0
Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population)
Timepoint [2] 0 0
12 months (48 weeks)
Secondary outcome [3] 0 0
Summary of Retention in Treatment (Efficacy Population)
Timepoint [3] 0 0
48 weeks of treatment
Secondary outcome [4] 0 0
Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population)
Timepoint [4] 0 0
12 months- 48 week
Secondary outcome [5] 0 0
Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population)
Timepoint [5] 0 0
12 months- 48 week
Secondary outcome [6] 0 0
Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)
Timepoint [6] 0 0
12 months- 48 week
Secondary outcome [7] 0 0
Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)
Timepoint [7] 0 0
12 months- 48 week

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2017
Sample size
Target
Accrual to date
Final
228
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Newcastle Community Health Services - Newcastle
Recruitment hospital [2] 0 0
Drug & Alcohol Services SA Drug and Alcohol Services - Norwood
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [4] 0 0
South Eastern Sydney Local Health District (SESLHD) - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2300 - Newcastle
Recruitment postcode(s) [2] 0 0
5070 - Norwood
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
NSW 2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
Denmark
State/province [7] 0 0
Aarhus
Country [8] 0 0
Denmark
State/province [8] 0 0
Odense
Country [9] 0 0
Germany
State/province [9] 0 0
Heilbronn
Country [10] 0 0
Germany
State/province [10] 0 0
Kassel
Country [11] 0 0
Germany
State/province [11] 0 0
Mannheim
Country [12] 0 0
Germany
State/province [12] 0 0
Regensburg
Country [13] 0 0
Germany
State/province [13] 0 0
Stuttgart
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Sweden
State/province [15] 0 0
Stockholm
Country [16] 0 0
Sweden
State/province [16] 0 0
Västerås
Country [17] 0 0
Taiwan
State/province [17] 0 0
Tainan County
Country [18] 0 0
Taiwan
State/province [18] 0 0
Taichung
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taipei
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Bristol
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Norwich
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Dundee
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Braeburn Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Frost, MD
Address 0 0
Frost Medical Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02672111