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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Carolinas Pain Institute
• Collaborator: BioDelivery Sciences International
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

1. 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

2. 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).

3. Able to read and speak English and provide informed consent.

4. Age 18-65.

5. 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).

6. 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.

7. 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)

8. Subjects must agree to try to stay as functional as possible (defined by only tolerable increase in pain with function or function testing)

9. 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

10. Subjects must have and maintain a working phone

11. CMP, CBC, UDS, EKG within normal limits at the discretion of the PI.

-

Exclusion Criteria:

1. Subjects with hypersensitivity to Opioids, Acetaminophen, buprenorphine or Belbuca®

2. Subjects taking equal to or more than 100 morphine milliequivalents,

3. Subjects with severe or untreated psychiatric disturbance (e.g. mania, depression [esp suicidality], anxiety, substance use disorder etc). This exclusion at the discretion of the PI.

4. A known or admitted history of opioid abuse, diversion or addiction.

5. 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.

6. 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.

7. Subjects who are currently talking MAO inhibitors (must have been off for > 14 days)

8. Subjects with planned surgery or invasive/interventional procedures.

9. Subjects must be willing to comply with visit and phone contact schedule, and try to stay as active and 'functional' as they can.

10. Subjects cannot be involved in any litigation concerning Workers Compensation or lawsuit concerning injury.

-