A Multiple Dose Opioid Challenge Study

NCT02611752 | Completed Phase 2 Results

• 1 other identifier: HS-13-478
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

Brief Summary

Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in patients with moderate or severe opioid use disorder.

Conditions

Moderate or Severe Opioid Use Disorder

Outcome Measures

Primary Outcomes (4)

• Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg

  Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.

  17 days

• Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg

  Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population), where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.

  17 days

• Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg

  Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.

  17 days

• Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg

  Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 32 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.

  17 days

Secondary Outcomes (7)

• Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)

  15 days

• Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)

  15 days

• Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)

  15 days

• Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)

  15 days

• Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)

  15 days

Study Arms (2)

CAM2038 q1w, 24 mg

EXPERIMENTAL

CAM2038 q1w 24 mg will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13

Drug: CAM2038

CAM2038 q1w, 32 mg

EXPERIMENTAL

CAM2038 q1w 32 mg will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13

Drug: CAM2038

Interventions

CAM2038 DRUG

CAM2038 subcutaneous injection

CAM2038 q1w, 24 mg; CAM2038 q1w, 32 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient had to provide written informed consent prior to the conduct of any study-related procedures.
• Male or female, 18-55 years of age, inclusive.
• Patients with a diagnosis of moderate or severe opioid use disorder (DSM-V) who were physically dependent on intravenous (IV) or insufflated opioids, and who were willing to undergo short-term BPN treatment.
• Self-reported opioid-use of a minimum of 21 days in the 30 days prior to Screening.
• Positive UDS for opioids at Screening or at check-in. If UDS was not positive, patients had to present with physical signs of withdrawal, as determined by the Investigator. The Investigator may have administered a naloxone challenge, in order to confirm opioid dependence at the Investigator's discretion.
• Female patients of childbearing potential had to be willing to use a reliable method of contraception during the entire study (Screening Visit to Follow-up Phone Call).
• Female patients of non-childbearing potential were surgically sterile (i.e., had undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels.
• Male patients with female partners of childbearing potential had to agree to use a reliable method of contraception from Screening Visit through at least 3 months after the last dose of study drug. Male patients also must have agreed not to donate sperm during the study through at least 3 months after the last dose of study drug.
• Were willing and able to comply with the study requirements (including blood sampling), complete study assessments, visit the clinic, and remain confined in the CRU for up to 25 consecutive days.

You may not qualify if:

• History or presence of any clinically significant psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening, which in the opinion of the Investigator would have jeopardized the safety of the patient or the validity of the study results.
• Opioid-dependent patients who were actively seeking treatment for their moderate to severe opioid use disorder.
• Patients with positive UDS for BPN, barbiturates, or methadone or breath alcohol on the day of check-in to the CRU.
• 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 the upper limit of normal on the Screening laboratory assessments and at inpatient check-in, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may have prevented the patient from safely participating in study.
• Any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead electrocardiogram (\[ECG\], QTcF ≥450 msec for males or ≥470 msec for females), and laboratory evaluation (including hematology, clinical chemistry, urinalysis, and serology \[optional\]) at Screening, in the opinion of the Investigator.
• Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would have precluded compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may have prevented the patient from safely participating in study (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator's Brochure for CAM2038).
• Patients were carefully screened to exclude individuals presenting with a clinically significant history of seizure disorders, history of asthma or other respiratory disorders, head injury, hypertension, or personal history of cardiovascular disease or clinically significant ECG abnormalities.
• Current diagnosis of Acquired Immune Deficiency Syndrome.
• Current diagnosis of chronic pain requiring opioids for treatment.
• Patients who met the criteria for a diagnosis of moderate or severe substance use disorder according to DSM-V criteria for any other substances other than opioids, caffeine, or tobacco.
• Pregnant or lactating, or planned to become pregnant during the study.
• Clinically significant history of or current evidence of suicidal ideation or active suicidal behavior as based on the Columbia-Suicide Severity Rating Scale (C-SSRS; grade 4 or 5).
• Hypersensitivity or allergy to BPN or other opioids or excipients of CAM2038.
• Intolerance to venipuncture and/or difficulty with venous access, as per the judgment of the Investigator/research staff.
• Patient was using an investigational drug or monoamine oxidase inhibitor or had used such within the last 30 days (or 5 times the half-life of the drug, if known and longer) prior to first drug administration in the Qualification Phase (i.e., IR morphine sulfate).

Sponsors & Collaborators

• Braeburn Pharmaceuticals: lead

Study Sites (3)

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

University of Kentucky

Lexington, Kentucky, 40513, United States

Location

New York Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (2)

• Bjornsson M, Acharya C, Strandgarden K, Tiberg F. Population Pharmacokinetic Analysis Supports Initiation Treatment and Bridging from Sublingual Buprenorphine to Subcutaneous Administration of a Buprenorphine Depot (CAM2038) in the Treatment of Opioid Use Disorder. Clin Pharmacokinet. 2023 Oct;62(10):1427-1443. doi: 10.1007/s40262-023-01288-6. Epub 2023 Aug 16.

  PMID: 37584841 DERIVED

• Walsh SL, Comer SD, Lofwall MR, Vince B, Levy-Cooperman N, Kelsh D, Coe MA, Jones JD, Nuzzo PA, Tiberg F, Sheldon B, Kim S. Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):894-902. doi: 10.1001/jamapsychiatry.2017.1874.

  PMID: 28655025 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular; Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; 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

• Sharon Walsh, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 23, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 14, 2019
• Results First Posted: November 14, 2019

Record last verified: 2018-08

Locations

US (3)