True Functional Restoration and Analgesia in Non-Radicular Low Back Pain

NCT05419297 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: IIR CLBP 8.16.21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To study the response of objective and quasi-objective 'True' functional outcomes, analgesia and safety in chronic non-radicular back pain to buprenorphine buccal film (BBF) using a small 'n' phase IV design. To assess associations between traditional pain relevant subjective outcomes and objective or quasi-objective functional outcomes; In a small 'n' construct, to assess more powerful, 'new' statistical methods (e.g. hierarchical linear models, joint trajectory analysis) compared to traditional methods, in the context of increased power, more objective outcomes and cost savings. First a 2-week washout of any opioid medication (if necessary; if not necessary subject can proceed directly to); baseline week (Single Blind Placebo Lead In (SBPLI), using the placebo film resembling the 150mcg dose; then randomization to a \~ 2 week up titration either to effective Buprenorphine Buccal Film (BBF) dose 2 day average pain better than or equal to 3/10 NRS), highest tolerated dose BBF and/or maximum dose BBF of 900 mcg BID, or identical placebo material up to these parameters. This up titration is at the discretion and timing of the blinded and experienced PI. Subject will be allowed two doses of hydrocodone/acetaminophen 5/325 daily during the washout period. A single experienced practitioner will manage the titration as to safety, detail and timing; and determine when the subject enters the 8 week stable dose trial; this practitioner will remain blinded throughout unless there is an urgent, safety reason for unblinding

Conditions

Back Pain Lower Back Chronic; Chronic Pain

Keywords

pain

Outcome Measures

Primary Outcomes (9)

• Numberic Rating Scale

  Numeric rating scale pain scores (0-10; 0- no pain, 10 - worst pain imaginable) will be recorded on a daily basis in the placebo and active comparator groups.

  20 weeks

• Patient global impression of function

  2 questions administered through an e-dairy on a daily basis to assess subject's impression fo function. Numeric scale: 0 no functional impairment due to pain; 10 total functional impairment due to pain

  20 weeks

• Patient Reported Outcomes Information System - Sleep

  Subjects will be provided a 5 point scale to rate sleep which will be scored. 4 - 20 higher score shows the most sleep disturbance, lower score is no sleep disturbance

  20 weeks

• Activity - steps per day

  Actigraph data, using a garmin device, will be gathered to record the number of steps the subject took in a 24 hour time period

  20 weeks

• Activity - time sitting

  Actigraph data, using a garmin device. Time sitting in hours and minutes will be recorded on a 24 hour time block

  20 weeks

• Sit to stand test

  Function - subjects will perform sit to stand test to measure pain and ability to perform such activity to compare the placebo and active comparator groups.

  20 weeks

• activity -sleep

  actigraph data, utilizing a garmin device, will be gathered recording time the subject was sleeping based on movements and heart rate in a 24 hour period

  20 weeks

• Timed stair climb

  9 steps will be ascended with or without the use of a handrail. Time will be recorded in seconds.

  20 weeks

• Patient Reported Outcomes Information System - 29

  29 questions about mood, sleep, and function will be gathered on a weekly basis via e-diary. This is scored, with 29 being the best outcome, and 100 the worst

  20 weeks

Secondary Outcomes (4)

• Function

  20 weeks

• Sleep

  20 weeks

• Activity

  20 weeks

• Bayesian analysis

  20 weeks

Study Arms (2)

Active drug arm

ACTIVE COMPARATOR

Subjects who meet eligibility criteria and complete a single blind placebo lead in will be provided placebo buprenorphine buccal film that mimics the actual drug comparator and is continued by a blinded individual throughout the duration of the trial.

Drug: Buprenorphine Buccal Film [Belbuca]; Other: Urine Drug Screening; Device: actigraph; Behavioral: PROMIS 29; Other: sit to stand test; Other: numerical rating scale pain score; Behavioral: patient global impression of function; Behavioral: PROMIS - sleep

Placebo arm

PLACEBO COMPARATOR

Subjects who meet eligibility criteria and complete a single blind placebo lead in will be provided active buprenorphine buccal film that is titrated to the effective dose and continued by a blinded individual throughout the duration of the trial.

Other: Urine Drug Screening; Device: actigraph; Behavioral: PROMIS 29; Other: sit to stand test; Other: numerical rating scale pain score; Behavioral: patient global impression of function; Behavioral: PROMIS - sleep

Interventions

Buprenorphine Buccal Film [Belbuca] DRUG

buprenorphine buccal film is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Also known as: Belbuca

Active drug arm

Urine Drug Screening OTHER

Urine drug screening to include controlled prescription medication as well as illicit substances to monitor compliance

Active drug arm; Placebo arm

actigraph DEVICE

Subjects will wear this device to monitor sleep and activity

Also known as: Garmin

Active drug arm; Placebo arm

PROMIS 29 BEHAVIORAL

questionnaire will be administered once a week via e-dairy to monitor mood and sleep

Active drug arm; Placebo arm

sit to stand test OTHER

Subjects will complete this daily with specific instructions through the e-diary

Active drug arm; Placebo arm

numerical rating scale pain score OTHER

subjects will be asked a pain score in the morning, prior to, and after sit-to-stand testing, and at night

Active drug arm; Placebo arm

patient global impression of function BEHAVIORAL

subjects will be asked three questions once a day to assess their personal impression of functional status

Active drug arm; Placebo arm

PROMIS - sleep BEHAVIORAL

Subjects will answer 5 questions about sleep every morning via e-diary

Active drug arm; Placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets our criteria for CNRBP:
• Pain of 3 months or more duration
• non-radiating (below buttocks or above lower back pain)
• no decreased sensation or allodynia/hyperalgesia in a radicular pattern
• no reflex asymmetry
• no frank weakness or atrophy
• no non-pain sensory or reflex changes
• If female, not pregnant or breast feeding, and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl).
• Able to read and speak English and provide informed consent.
• Age 18-65.
• Able to understand and comply with all data collection methodology, and demonstrated ability to manage the electronic diary system (as tested in 'detox' and baseline/SBPLI period).
• Subjects may continue any non-opioid stable scheduled drug regimen with no changes during the course of study, hydrocodone/acetaminophen 5/325 up to two doses per day along with Tylenol 2g/day are the only allowed rescue medications. Subjects are asked not to use the rescue medication 12 hours or less before testing.
• Subjects taking opioids must agree to 'detoxify' for the protocol under the supervision of the study medical personnel. Subjects may use hydrocodone/acetaminophen 5/325 twice daily for breakthrough pain, as provided to them during the study, and must use only the hydrocodone/acetaminophen provided (with a pill count is a secondary outcome)
• Subjects must agree to try to stay as functional as possible (defined by only tolerable increase in pain with function or function testing)
• Must have 'average' pain greater than or equal to 4 and no greater that 9 on a 10-point NRS scale at phone screening and first visit

You may not qualify if:

• Subjects with hypersensitivity to Opioids, Acetaminophen, buprenorphine or Belbuca®
• Subjects taking equal to or more than 100 morphine milliequivalents,
• A known or admitted history of opioid abuse, diversion or addiction.
• Subjects with severe, ongoing or unaddressed medical conditions (e.g. Renal or Hepatic disease i. \[creatinine\>1.5 ml/dl; AST or ALT\> 2x normal limit\], severe or uncontrolled hypertension, pulmonary ii. disease, seizure disorder or gastroparesis or urinary retention.
• Subjects with a clinical diagnosis of fibromyalgia, polymyalgia rheumatica, spinal stenosis or non-osteoarthritis i. rheumatologic disease or severe chronic pain disorder of other body regions.
• Subjects who are currently talking MAO inhibitors (must have been off for \> 14 days)
• Subjects with planned surgery or invasive/interventional procedures.
• Subjects must be willing to comply with visit and phone contact schedule, and try to stay as active and 'functional' as they can.
• Subjects cannot be involved in any litigation concerning Workers Compensation or lawsuit concerning injury.

Sponsors & Collaborators

• Carolinas Pain Institute: lead
• BioDelivery Sciences International: collaborator

Study Sites (1)

Carolinas Pain Institute

Winston-Salem, North Carolina, 27103, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Study Officials

• AMANDA A ZIMMERMAN, PA-C

  West Forsyth Pain Management

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Zimmerman, PA-C

CONTACT

3367409444; dmczim@gmail.com

Richard Rauck, MD

CONTACT

3367656181; rrauck@ccrpain.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Two designated staff will be unblinded, and be responsible for providing the subjects with envelopes containing either drug or placebo. Principal investigator and the remainder of the staff will be blinded throughout the duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A double blind, placebo controlled, phase IV clinical trial. Following a two week washout of opioid medication, a two week single blind placebo lead in, subjects will be randomized into two groups. One group to receive placebo film, and the other to be titrated to effect with buprenorphine buccal film.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: June 15, 2022
• Study Start: August 3, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)