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Randomized Controlled Trial
. 2013 Dec;108(12):2141-9.
doi: 10.1111/add.12315. Epub 2013 Sep 18.

Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone

Richard N Rosenthal  1 , Walter Ling, Paul Casadonte, Frank Vocci, Genie L Bailey, Kyle Kampman, Ashwin Patkar, Steven Chavoustie, Christine Blasey, Stacey Sigmon, Katherine L Beebe
Affiliations
Randomized Controlled Trial

Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone

Richard N Rosenthal et al. Addiction. 2013 Dec.

Abstract

Aims: To evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open-label sublingual buprenorphine/naloxone tablets (BNX).

Design: Randomized, double-blind, placebo-controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open-label BNX (12-16 mg/day) (n = 119).

Setting: Twenty addiction treatment centers.

Participants: Adult out-patients (ages 18-65) with DSM-IV-TR opioid dependence.

Measurements: The primary efficacy end-point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF).

Findings: The BI CDF was significantly different from placebo (P < 0.0001). Mean [95% confidence interval (CI)] proportions of urines negative for opioids were: BI = 31.2% (25.3, 37.1) and PI = 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64 versus 26%, P < 0.0001), lower clinician-rated (P < 0.0001) and patient-rated (P < 0.0001) withdrawal, lower patient-ratings of craving (P < 0.0001) and better subjects' (P = 0.031) and clinicians' (P = 0.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P = 0.0016). Minor implant-site reactions were comparable in the buprenorphine [27.2% (31 of 114)] and placebo groups [25.9% (14 of 54)]. BI were non-inferior to BNX on percentage of urines negative for opioids [mean (95% CI) = 33.5 (27.3, 39.6); 95% CI for the difference of proportions = (-10.7, 6.2)].

Conclusions: Compared with placebo, buprenorphine implants result in significantly less frequent opioid use and are non-inferior to sublingual buprenorphine/naloxone tablets.

Trial registration: ClinicalTrials.gov NCT01114308.

Keywords: Buprenorphine; drug addiction; drug implants; maintenance therapy; opioid dependence; treatment adherence.

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Figures

Figure 1
Figure 1
Flow Diagram of Participants Through the Trial
Figure 2
Figure 2
Cumulative Distribution Functions of Percentage of Urine Samples Negative for Opioids
See this image and copyright information in PMC

Comment in

References

    1. Soyka M, Kranzler HR, Van den Brink W, Krystal J, Möller HJ, Kasper S and the WFSBP Task Force for Treatment Guidelines on Substance Use Disorders. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of substance use and related disorders, part 2: opioid dependence. The World Journal of Biological Psychiatry. 2011;12:160–187. - PubMed
    1. Luty J, O’Gara C, Sessay M. Is methadone too dangerous for opiate addiction? BMJ. 2005;331:1352–1353. - PMC - PubMed
    1. Centers for Disease Control and Prevention (CDC) Buprenorphine prescribing practices and exposures reported to a poison center--Utah, 2002–2011. MMWR Morb Mortal Wkly Rep. 2012;61(49):997–1001. - PubMed
    1. Centers for Disease Control and Prevention (CDC) Emergency department visits involving nonmedical use of selected prescription drugs - United States, 2004–2008. MMWR Morb Mortal Wkly Rep. 2010;59(23):7059. - PubMed
    1. Johanson CE, Arfken CL, di Menza S, Schuster CR. Diversion and abuse of buprenorphine: findings from national surveys of treatment patients and physicians. Drug Alcohol Depend. 2012;120(1–3):190–195. - PubMed

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