What is the RR of an episode ending with pain relief of ≥33% comparing one treated with FBT to a placebo?

Background: Supervised injection facilities (SIFs) are legally sanctioned environments for people to inject drugs under medical supervision. SIFs currently operate in ten countries, but to date, no SIF has been opened in the USA. In light of increasing overdose mortality in the USA, this study evaluated willingness to use a SIF among youth who report non-medical prescription opioid (NMPO) use. Methods: Between January 2015 and February 2016, youth with recent NMPO use were recruited to participate in the Rhode Island Young Adult Prescription Drug Study (RAPiDS). We explored factors associated with willingness to use a SIF among participants who had injected drugs or were at risk of initiating injection drug use (defined as having a sex partner who injects drugs or having a close friend who injects). Results: Among 54 eligible participants, the median age was 26 (IQR = 24-28), 70.4% were male, and 74.1% were white. Among all participants, when asked if they would use a SIF, 63.0% answered “Yes”, 31.5% answered “No”, and 5. 6% were unsure. Among the 31 participants reporting injection drug use in the last six months, 27 (87.1%) reported willingness to use a SIF; 15 of the 19 (78.9%) who injected less than daily reported willingness, while all 12 (100.0%) of the participants who injected daily reported willingness. Compared to participants who were unwilling or were unsure, participants willing to use a SIF were also more likely to have been homeless in the last six months, have accidentally overdosed, have used heroin, have used fentanyl non-medically, and typically use prescription opioids alone. Conclusions: Among young adults who use prescription opioids non-medically and inject drugs or are at risk of initiating injection drug use, more than six in ten reported willingness to use a SIF. Established risk factors for overdose, including homelessness, history of overdose, daily injection drug use, heroin use, and fentanyl misuse, were associated with higher SIF acceptability, indicating that young people at the highest risk of overdose might ultimately be the same individuals to use the facility. Supervised injection facilities merit consideration to reduce overdose mortality in the USA.

A.      What type of study is this and why might they have used this design? (2pts)

B.      Describe the study population and the comparison group. (2pts)

C.      Should any of these results be standardized and why or why not? (2pts)

D.      What are some concerns (as an epidemiologist) you might have about these results and why? (2pts)

7.       Objective. To evaluate the time of onset, overall efficacy, and safety of fentanyl buccal tablet (FBT) for noncancer-related breakthrough pain (BTP) in opioid-tolerant adults over 12 weeks. Design. A novel 12-week study that mimicked clinical practice with dose titration to effective dose, open-label treatment, and three randomized, double–blind, placebo-controlled, multiple-crossover periods at weeks 4, 8, and 12. For each double–blind period, study patients received nine doses (FBT = 6, placebo = 3) in a randomized sequence. Setting. Twenty-one study centers in the United States. Population. Opioid-tolerant adults with noncancer-related chronic pain and BTP. Outcome Measures. The primary outcome was the sum of the pain intensity differences (PID) 5–60 minutes post dose (SPID60) during the final double–blind period. Secondary outcomes included pain relief (PR), meaningful PR, and proportion of episodes with a PID of ≥33% and ≥50%. Results. Of 148 patients who entered the titration phase, 105 (71%) achieved a successful dose and 81 (55%) participated in all three assessment periods in the study. The final RCT assessment period results demonstrated continued efficacy of FBT vs placebo ( P < 0.05) for SPID60 (mean [SD]: 7.7 [6.2] vs 4.6 [4.7]). The average onset of PR began at 5 minutes, with meaningful PR by ≤10 minutes. The proportion of episodes with ≥33% improvement in PI was 7% with FBT vs 3% with placebo at 5 minutes and with ≥50% was 17% vs 10% at 15 minutes. All periods showed similar results. Adverse events and patient discontinuations were generally typical of clinical opioid use. Conclusions. FBT showed continued clinically important analgesic effects and was generally well tolerated over 12 weeks of treatment.

A.      Why is a placebo being used?(2pts)

B.      Who is being treated and who is being given a placebo? (2pts)

C.      What is the RR of an episode ending with pain relief of ≥33% comparing one treated with FBT to a placebo? (1pt)

D.      By 10 minutes how many episodes of breakthrough pain result in ≥50% improvement in pain intensity and how does that compare to those who are treated? (1pt)

E.       Overall what is your impression of this as a solution to break through pain and why? (2pts)