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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02672111
Ethics application status
Date submitted
15/01/2016
Date registered
3/02/2016
Date last updated
15/05/2020

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
Treatment: Drugs - CAM2038 q1w or q4w exposure to SL BPN/NX
Treatment: Drugs - CAM2038 q1w or q4w new to BPN treatment

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


Treatment: Drugs: CAM2038 q1w or q4w exposure to SL BPN/NX


Treatment: Drugs: CAM2038 q1w or q4w new to BPN treatment


Intervention code [1] 0 0
Treatment: Drugs
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 - Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-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 - 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
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) - 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)
Timepoint [1] 0 0
12 months (48 weeks)
Secondary outcome [2] 0 0
Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population) - 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.
Timepoint [2] 0 0
12 months (48 weeks)
Secondary outcome [3] 0 0
Summary of Retention in Treatment (Efficacy Population) - The following is a summary of treatment retention over 48 weeks
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) - 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
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) - 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
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) - 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.
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) - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT02672111
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

Summary results
Other publications