Last updated on July 2018

Structured Discontinuation vs Continued Therapy in Suboptimal and Optimal Responders to High-dose Long-term Opioids for Chronic Pain


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Opiate Addiction | Drug Abuse | Narcotic Abuse | Opioid-Related Disorders
  • Age: Between 18 - 75 Years
  • Gender: Male or Female
  • Other:
    Be male or non-pregnant, non-lactating female aged 18 to 75 years, inclusive.
    Have a clinical diagnosis of non-radicular CLBP (pain that occurs in an area with
    boundaries between the lowest rib and the crease of the buttocks) of Class 1 or
    proximal radicular (above the knee) pain of Class 2 based on the Quebec Task Force
    Classification for Spinal Disorders (subjects with previous surgery or chronic pain
    yndrome, i.e., classes 9.2 or 10, will be allowed if their pain does not radiate or
    radiates only proximally) for a minimum of 12 months and
    For the Suboptimal Responder group, pain must have been present for at least
    everal hours a day and have an Average PI score of 6-9 on an 11-point NRS within
    the past 24 hours of screening.
    For the Optimal Responder group, subjects must have an Average PI score of 1-4 on
    an 11-point NRS within the past 24 hours of screening.
    Have been taking ER/LA opioids or immediate release opioids (at least 4 times at day)
    for at least 12 months.
    Have been taking one of the 3 index ER opioid drugs around-the-clock at a twice-a-day
    frequency for at least 3 consecutive months at a total daily dose within the range
    hown below.
    Daily Dose Range
    Morphine sulfate extended-release: 120-540mg
    Oxycodone extended-release: 80-360mg
    Oxymorphone extended-release: 40-180mg
    Be considered, in the opinion of the Investigator, to be in generally good health
    other than CLBP at screening based upon the results of a medical history, physical
    examination, 12-lead ECG, and laboratory profile.
    Speak, read, write, and understand English (to reduce heterogeneity of data),
    understand the consent form, and be able to effectively communicate with the study
    taff.
    Have access to the Internet (to access the patient support program).
    Voluntarily provide written informed consent.
    Be willing and able to complete study procedures.

You may not be eligible for this study if the following are true:

  • Have any clinically significant condition that would, in the opinion of the
    Investigator, preclude study participation or interfere with the assessment of pain
    and other symptoms of CLBP or increase the risk of opioid-related AEs.
    Have a primary diagnosis of fibromyalgia, complex regional pain syndrome, neurogenic
    claudication due to spinal stenosis, spinal cord compression, acute nerve root
    compression, severe or progressive lower extremity weakness or numbness, bowel or
    bladder dysfunction as a result of cauda equina compression, diabetic amyotrophy,
    meningitis, diskitis, back pain because of secondary infection or tumor, or pain
    caused by a confirmed or suspected neoplasm.
    Have undergone a surgical procedure for back pain within 6 months prior to the
    Screening Visit.
    Have had a nerve or plexus block, including epidural steroid injections or facet
    blocks, within 1 month prior to the Screening Visit or botulinum toxin injection in
    the lower back region within 3 months prior to screening.
    Have a history of confirmed malignancy within past 2 years, with exception of basal
    cell or squamous cell carcinoma of the skin that has been successfully treated.
    Have uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure
    >180 mm Hg or <90 mm Hg, or a sitting diastolic blood pressure >110 mmHg or <40 mm Hg
    at screening.
    Have a body mass index (BMI) >45 kg/m2. Anyone with a BMI >40 but <45 with complete a
    creening tool (STOPBang Questionnaire) to rule out high risk of obstructive sleep
    apnea.
    Have clinically significant depression based on a score of ≥20 on the Patient Health
    Questionnaire (PHQ-8)
    Have suicidal ideation associated with actual intent and a method or plan in the past
    year: "Yes" answers on items 4 or 5 of the Columbia-Suicide Severity Rating Scale
    (C-SSRS).
    Have a previous history of suicidal behaviors in the past 5 years: "Yes" answer (for
    events that occurred in the past 5 years) to any of the suicidal behavior items of the
    C-SSRS.
    Have any lifetime history of serious or recurrent suicidal behavior. (Non-suicidal
    elf-injurious behavior is not a trigger for a risk assessment unless in the
    Investigator's judgment it is indicated.)
    Have clinically significant abnormality in clinical chemistry, hematology or
    urinalysis, including serum glutamic-oxaloacetic transaminase/aspartate
    aminotransferase or serum glutamic pyruvic transaminase/alanine aminotransferase ≥3
    times the upper limit of the reference range or a serum creatinine >2 mg/dL at
    creening.
    Have severe enough psychiatric or substance abuse disorder to compromise the subject's
    afety or scientific integrity of the study.
    Have on-going litigation associated with back pain or pending applications for workers
    compensation or disability issues or subjects who plan on filing litigation or claims
    within the next 12 months; subjects with settled past litigations will be allowed as
    will subjects who have been on workers compensation or disability claims for at least
    3 months.
    Have used a monoamine oxidase inhibitor within 14 days prior to the start of study
    medication.
    Are taking agonist-antagonists (pentazocine, butorphanol or nalbuphine),
    buprenorphine, methadone, barbiturates, or more than one type of benzodiazepine within
    1 month prior to screening.
    Have a positive UDT for illicit drugs (including marijuana), non-prescribed controlled
    ubstances (opioid or non-opioid), or alcohol at screening.
    Have taken any investigational drug within 30 days prior to the Screening Visit or are
    currently enrolled in another investigational drug study.

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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