Trial reportPain2016
Efficacy and tolerability of buccal buprenorphine in opioid-experienced patients with moderate to severe chronic low back pain: results of a phase 3, enriched enrollment, randomized withdrawal study.
Trial report in Pain, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 24 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 56 citations in OpenAlex.
- Pooled it
- Pooled it
- Buprenorphine for Chronic Pain: a Systemic Review.Current pain and headache reports · 2018Pooled it
- A Phase I Placebo-Controlled Trial Comparing the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration on Respiratory Drive.Advances in therapy · 2020Trial
- Economic and Treatment Burden of Chronic Low-Back Pain Patients Transitioning from Short-Acting to Long-Acting Opioids or Buprenorphine Buccal Film: US Claims Analysis.Pain and therapy · 2026Article
- Serious treatment-emergent adverse events in chronic low back pain patients treated with buprenorphine or oral opioids: a retrospective commercial claims analysis.Journal of comparative effectiveness research · 2024Article
- Frontline Perspectives on Buprenorphine for the Management of Chronic Pain.Journal of multidisciplinary healthcare · 2024Review
- Buprenorphine for Chronic Pain Management: a Narrative Review.Current pain and headache reports · 2023Review
- An Examination of the Complex Pharmacological Properties of the Non-Selective Opioid Modulator Buprenorphine.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Pharmacotherapy for Spine-Related Pain in Older Adults.Drugs & aging · 2022Review
- Are we ready to manage an opioid epidemic in the intensive care unit?Anaesthesiology intensive therapy · 2022Review
- Study Design Characteristics and Endpoints for Enriched Enrollment Randomized Withdrawal Trials for Chronic Pain Patients: A Systematic Review.Journal of pain research · 2022Review
- Buprenorphine and its formulations: a comprehensive review.Health psychology research · 2022Article
- Efficacy and tolerability of tapentadol for the treatment of chronic low back pain in elderly patients.Aging clinical and experimental research · 2021Article
- Benefit-Risk Analysis of Buprenorphine for Pain Management.Journal of pain research · 2021Review
- Transmucosal Buprenorphine in the Treatment of Dyspnea: Case Series and Review of the Literature.Palliative medicine reports · 2021Article
- Article
- A Narrative Pharmacological Review of Buprenorphine: A Unique Opioid for the Treatment of Chronic Pain.Pain and therapy · 2020Review
- Safety And Efficacy Of The Unique Opioid Buprenorphine For The Treatment Of Chronic Pain.Journal of pain research · 2019Review
- Treating Chronic Pain: An Overview of Clinical Studies Centered on the Buprenorphine Option.Drugs · 2018Review
Corrections and comments
- Erratum issuedErratum.2017
Authors and funding
6 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A buccal film of buprenorphine (BBUP) was evaluated for safety and efficacy in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-experienced patients (30 to ≤160 mg/d morphine sulfate equivalent) with moderate to severe chronic low back pain taking around-the-clock opioid analgesics. Patients' opioid doses were tapered to ≤30 mg morphine sulfate equivalent before open-label titration with BBUP (range, 150-900 μg every 12 hours). Patients who responded (received adequate analgesia that was generally well tolerated for 14 days) were randomized to receive buprenorphine (n = 254) or placebo (n = 257) buccal film. The primary efficacy variable was the change from baseline to week 12 of double-blind treatment in mean average daily pain-intensity scores using a rating scale of 0 (no pain) to 10 (worst pain imaginable). In the intent-to-treat population, mean pain scores were 6.7 after opioid taper and declined to 2.8 after the BBUP titration period. After randomization, mean pain scores were lower in the BBUP group than in the placebo group; the difference between groups in the mean change from baseline to week 12 was -0.98 (95% CI, -1.32 to -0.64; P < 0.001). A significantly larger percentage of patients receiving BBUP than placebo had pain reductions ≥30% and ≥50% (P < 0.001 for both). In the double-blind portion of the study, the only adverse event reported more frequently with BBUP than placebo and in ≥5% of patients was vomiting (5.5% vs 2.3%). These findings demonstrate the efficacy and tolerability of BBUP in opioid-experienced patients taking around-the-clock opioid treatment for chronic low back pain.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.