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

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

Interventions

DRUG

Buprenorphine Buccal Film [Belbuca]

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.

OTHER

Urine Drug Screening

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

DEVICE

actigraph

Subjects will wear this device to monitor sleep and activity

BEHAVIORAL

PROMIS 29

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

OTHER

sit to stand test

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

OTHER

numerical rating scale pain score

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

BEHAVIORAL

patient global impression of function

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

BEHAVIORAL

PROMIS - sleep

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

Sponsors & Collaborators

• BioDelivery Sciences International

  collaborator INDUSTRY

• Carolinas Pain Institute

  lead OTHER

Principal Investigators

• AMANDA A ZIMMERMAN, PA-C · West Forsyth Pain Management

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-08-03

Primary Completion

2023-07-31

Completion

2023-07-31

FDA Drug

Yes

Countries

• United States

Study Locations