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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672111
Recruitment Status : Completed
First Posted : February 3, 2016
Results First Posted : August 1, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Braeburn Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: CAM2038 q1w or q4w exposure to SL BPN/NX Drug: CAM2038 q1w or q4w new to BPN treatment Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/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

Drug: CAM2038 q1w or q4w exposure to SL BPN/NX
Other Name: Buprenorphine injection

Experimental: CAM2038 q1w or q4w new to BPN treatment
CAM2038 (buprenorphine FluidCrystal®) New to BPN Treatment who received CAM2038r q1w or q4w
Drug: CAM2038 q1w or q4w new to BPN treatment
Other Name: Buprenorphine injection




Primary Outcome Measures :
  1. Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population [ Time Frame: 12 months- 48 week ]
    Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population

  2. Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population [ Time Frame: 12 months- 48 week ]
    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


Secondary Outcome Measures :
  1. Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population) [ Time Frame: 12 months (48 weeks) ]
    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)

  2. Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population) [ Time Frame: 12 months (48 weeks) ]
    The following is a summary of Mean Percentage of Self-Reported No Illicit Opioid Use (Efficacy Population)

  3. Summary of Retention in Treatment (Efficacy Population) [ Time Frame: 48 weeks of treatment ]
    The following is a summary of treatment retention over 48 weeks

  4. Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population) [ Time Frame: 12 months- 48 week ]
    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

  5. Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population) [ Time Frame: 12 months- 48 week ]
    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

  6. Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) [ Time Frame: 12 months- 48 week ]
    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.

  7. Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) [ Time Frame: 12 months- 48 week ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672111


Locations
Show Show 32 study locations
Sponsors and Collaborators
Braeburn Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Michael Frost, MD Frost Medical Group
  Study Documents (Full-Text)

Documents provided by Braeburn Pharmaceuticals:
Statistical Analysis Plan  [PDF] April 20, 2017
Study Protocol  [PDF] December 9, 2016


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Braeburn Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02672111    
Other Study ID Numbers: HS-14-499
First Posted: February 3, 2016    Key Record Dates
Results First Posted: August 1, 2019
Last Update Posted: November 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Buprenorphine
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists