Buprenorphine implants for treatment of opioid dependence

A randomized controlled trial

Walter Ling, Paul Casadonte, George Bigelow, Kyle M. Kampman, Ashwin Patkar, Genie L. Bailey, Richard N. Rosenthal, Katherine L. Beebe

Research output: Contribution to journalArticle

Abstract

Context: Limitations of existing pharmacological treatments for opioid dependence include low adherence, medication diversion, and emergence of withdrawal symptoms. Objective: To determine the efficacy of buprenorphine implants that provide a low, steady level of buprenorphine over 6months for the treatment of opioid dependence. Design, Setting, and Participants: A randomized, placebo-controlled, 6-month trial conducted at 18 sites in the United States between April 2007 and June 2008. One hundred sixty-three adults, aged 18 to 65 years, diagnosed with opioid dependence. One hundred eight were randomized to receive buprenorphine implants and 55 to receive placebo implants. Intervention: After induction with sublingual buprenorphine-naloxone tablets, patients received either 4 buprenorphine implants (80 mg per implant) or 4 placebo implants. A fifth implant was available if a threshold for rescue use of sublingual buprenorphine-naloxone treatment was exceeded. Standardized individual drug counseling was provided to all patients. Main Outcome Measure: The percentage of urine samples negative for illicit opioids for weeks 1 through 16 and for weeks 17 through 24. Results: The buprenorphine implant group had significantly more urine samples negative for illicit opioids during weeks 1 through 16 (P = .04). Patients with buprenorphine implants had a mean percentage of urine samples that tested negative for illicit opioids across weeks 1 through 16 of 40.4% (95% confidence interval [CI], 34.2%-46.7%) and a median of 40.7%; whereas those in the placebo group had a mean of 28.3% (95% CI, 20.3%-36.3%) and a median of 20.8%. A total of 71 of 108 patients (65.7%) who received buprenorphine implants completed the study vs 17 of 55 (30.9%) who received placebo implants (P <.001). Those who received buprenorphine implants also had fewer clinician-rated (P <.001) and patient-rated (P = .004) withdrawal symptoms, had lower patient ratings of craving (P <.001), and experienced a greater change on clinician global ratings of severity of opioid dependence (P <.001) and on the clinician global ratings of improvement (P <.001) than those who received placebo implants. Minor implant site reactions were the most common adverse events: 61 patients (56.5%) in the buprenorphine group and 29 (52.7%) in the placebo group. Conclusion: Among persons with opioid dependence, the use of buprenorphine implants compared with placebo resulted in less opioid use over 16 weeks as assessed by urine samples. Trial Registration: clinicaltrials.gov Identifier: NCT00447564.

Original languageEnglish (US)
Pages (from-to)1576-1583
Number of pages8
JournalJournal of the American Medical Association
Volume304
Issue number14
DOIs
StatePublished - Oct 13 2010

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Buprenorphine
Opioid Analgesics
Randomized Controlled Trials
Placebos
Urine
Therapeutics
Substance Withdrawal Syndrome
Confidence Intervals
Medication Adherence
Tablets
Counseling
Outcome Assessment (Health Care)
Pharmacology

ASJC Scopus subject areas

  • Medicine(all)

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Buprenorphine implants for treatment of opioid dependence : A randomized controlled trial. / Ling, Walter; Casadonte, Paul; Bigelow, George; Kampman, Kyle M.; Patkar, Ashwin; Bailey, Genie L.; Rosenthal, Richard N.; Beebe, Katherine L.

In: Journal of the American Medical Association, Vol. 304, No. 14, 13.10.2010, p. 1576-1583.

Research output: Contribution to journalArticle

Ling, W, Casadonte, P, Bigelow, G, Kampman, KM, Patkar, A, Bailey, GL, Rosenthal, RN & Beebe, KL 2010, 'Buprenorphine implants for treatment of opioid dependence: A randomized controlled trial', Journal of the American Medical Association, vol. 304, no. 14, pp. 1576-1583. https://doi.org/10.1001/jama.2010.1427
Ling, Walter ; Casadonte, Paul ; Bigelow, George ; Kampman, Kyle M. ; Patkar, Ashwin ; Bailey, Genie L. ; Rosenthal, Richard N. ; Beebe, Katherine L. / Buprenorphine implants for treatment of opioid dependence : A randomized controlled trial. In: Journal of the American Medical Association. 2010 ; Vol. 304, No. 14. pp. 1576-1583.
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abstract = "Context: Limitations of existing pharmacological treatments for opioid dependence include low adherence, medication diversion, and emergence of withdrawal symptoms. Objective: To determine the efficacy of buprenorphine implants that provide a low, steady level of buprenorphine over 6months for the treatment of opioid dependence. Design, Setting, and Participants: A randomized, placebo-controlled, 6-month trial conducted at 18 sites in the United States between April 2007 and June 2008. One hundred sixty-three adults, aged 18 to 65 years, diagnosed with opioid dependence. One hundred eight were randomized to receive buprenorphine implants and 55 to receive placebo implants. Intervention: After induction with sublingual buprenorphine-naloxone tablets, patients received either 4 buprenorphine implants (80 mg per implant) or 4 placebo implants. A fifth implant was available if a threshold for rescue use of sublingual buprenorphine-naloxone treatment was exceeded. Standardized individual drug counseling was provided to all patients. Main Outcome Measure: The percentage of urine samples negative for illicit opioids for weeks 1 through 16 and for weeks 17 through 24. Results: The buprenorphine implant group had significantly more urine samples negative for illicit opioids during weeks 1 through 16 (P = .04). Patients with buprenorphine implants had a mean percentage of urine samples that tested negative for illicit opioids across weeks 1 through 16 of 40.4{\%} (95{\%} confidence interval [CI], 34.2{\%}-46.7{\%}) and a median of 40.7{\%}; whereas those in the placebo group had a mean of 28.3{\%} (95{\%} CI, 20.3{\%}-36.3{\%}) and a median of 20.8{\%}. A total of 71 of 108 patients (65.7{\%}) who received buprenorphine implants completed the study vs 17 of 55 (30.9{\%}) who received placebo implants (P <.001). Those who received buprenorphine implants also had fewer clinician-rated (P <.001) and patient-rated (P = .004) withdrawal symptoms, had lower patient ratings of craving (P <.001), and experienced a greater change on clinician global ratings of severity of opioid dependence (P <.001) and on the clinician global ratings of improvement (P <.001) than those who received placebo implants. Minor implant site reactions were the most common adverse events: 61 patients (56.5{\%}) in the buprenorphine group and 29 (52.7{\%}) in the placebo group. Conclusion: Among persons with opioid dependence, the use of buprenorphine implants compared with placebo resulted in less opioid use over 16 weeks as assessed by urine samples. Trial Registration: clinicaltrials.gov Identifier: NCT00447564.",
author = "Walter Ling and Paul Casadonte and George Bigelow and Kampman, {Kyle M.} and Ashwin Patkar and Bailey, {Genie L.} and Rosenthal, {Richard N.} and Beebe, {Katherine L.}",
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T2 - A randomized controlled trial

AU - Ling, Walter

AU - Casadonte, Paul

AU - Bigelow, George

AU - Kampman, Kyle M.

AU - Patkar, Ashwin

AU - Bailey, Genie L.

AU - Rosenthal, Richard N.

AU - Beebe, Katherine L.

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N2 - Context: Limitations of existing pharmacological treatments for opioid dependence include low adherence, medication diversion, and emergence of withdrawal symptoms. Objective: To determine the efficacy of buprenorphine implants that provide a low, steady level of buprenorphine over 6months for the treatment of opioid dependence. Design, Setting, and Participants: A randomized, placebo-controlled, 6-month trial conducted at 18 sites in the United States between April 2007 and June 2008. One hundred sixty-three adults, aged 18 to 65 years, diagnosed with opioid dependence. One hundred eight were randomized to receive buprenorphine implants and 55 to receive placebo implants. Intervention: After induction with sublingual buprenorphine-naloxone tablets, patients received either 4 buprenorphine implants (80 mg per implant) or 4 placebo implants. A fifth implant was available if a threshold for rescue use of sublingual buprenorphine-naloxone treatment was exceeded. Standardized individual drug counseling was provided to all patients. Main Outcome Measure: The percentage of urine samples negative for illicit opioids for weeks 1 through 16 and for weeks 17 through 24. Results: The buprenorphine implant group had significantly more urine samples negative for illicit opioids during weeks 1 through 16 (P = .04). Patients with buprenorphine implants had a mean percentage of urine samples that tested negative for illicit opioids across weeks 1 through 16 of 40.4% (95% confidence interval [CI], 34.2%-46.7%) and a median of 40.7%; whereas those in the placebo group had a mean of 28.3% (95% CI, 20.3%-36.3%) and a median of 20.8%. A total of 71 of 108 patients (65.7%) who received buprenorphine implants completed the study vs 17 of 55 (30.9%) who received placebo implants (P <.001). Those who received buprenorphine implants also had fewer clinician-rated (P <.001) and patient-rated (P = .004) withdrawal symptoms, had lower patient ratings of craving (P <.001), and experienced a greater change on clinician global ratings of severity of opioid dependence (P <.001) and on the clinician global ratings of improvement (P <.001) than those who received placebo implants. Minor implant site reactions were the most common adverse events: 61 patients (56.5%) in the buprenorphine group and 29 (52.7%) in the placebo group. Conclusion: Among persons with opioid dependence, the use of buprenorphine implants compared with placebo resulted in less opioid use over 16 weeks as assessed by urine samples. Trial Registration: clinicaltrials.gov Identifier: NCT00447564.

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