Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: The Cocaine Use Reduction with Buprenorphine (CURB) study

Walter Ling, Maureen P. Hillhouse, Andrew J. Saxon, Larissa J. Mooney, Christie M. Thomas, Alfonso Ang, Abigail G. Matthews, Albert Hasson, Jeffrey Annon, Steve Sparenborg, David S. Liu, Jennifer McCormack, Sarah H. Church, William Swafford, Karen Drexler, Carolyn Schuman, Stephen Ross, Katharina Wiest, P. Todd Korthuis, William LawsonGregory S. Brigham, Patricia C. Knox, Michael Dawes, John Rotrosen

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Aims: To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone ®) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol ®) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Methods: This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 g/day BUP (BUP4, n 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 02). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. Results: No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 (P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. Conclusions: Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.

Original languageEnglish (US)
Pages (from-to)1416-1427
Number of pages12
JournalAddiction
Volume111
Issue number8
DOIs
StatePublished - Aug 1 2016

Fingerprint

Cocaine-Related Disorders
Buprenorphine
Naltrexone
Cocaine
Urine
Diagnostic and Statistical Manual of Mental Disorders
Opioid Analgesics
Odds Ratio
Placebos
Pharmaceutical Preparations
Medication Adherence
Cognitive Therapy
Therapeutics
Ambulatory Care
Tablets
Substance-Related Disorders
Clinical Trials
Safety
Drug Therapy
Injections

Keywords

  • Buprenorphine + naloxone
  • cocaine use disorder
  • double-blind
  • multi-site trial
  • naltrexone
  • pharmacotherapy
  • placebo-controlled
  • treatment

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Psychiatry and Mental health

Cite this

Ling, W., Hillhouse, M. P., Saxon, A. J., Mooney, L. J., Thomas, C. M., Ang, A., ... Rotrosen, J. (2016). Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: The Cocaine Use Reduction with Buprenorphine (CURB) study. Addiction, 111(8), 1416-1427. https://doi.org/10.1111/add.13375

Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence : The Cocaine Use Reduction with Buprenorphine (CURB) study. / Ling, Walter; Hillhouse, Maureen P.; Saxon, Andrew J.; Mooney, Larissa J.; Thomas, Christie M.; Ang, Alfonso; Matthews, Abigail G.; Hasson, Albert; Annon, Jeffrey; Sparenborg, Steve; Liu, David S.; McCormack, Jennifer; Church, Sarah H.; Swafford, William; Drexler, Karen; Schuman, Carolyn; Ross, Stephen; Wiest, Katharina; Korthuis, P. Todd; Lawson, William; Brigham, Gregory S.; Knox, Patricia C.; Dawes, Michael; Rotrosen, John.

In: Addiction, Vol. 111, No. 8, 01.08.2016, p. 1416-1427.

Research output: Contribution to journalArticle

Ling, W, Hillhouse, MP, Saxon, AJ, Mooney, LJ, Thomas, CM, Ang, A, Matthews, AG, Hasson, A, Annon, J, Sparenborg, S, Liu, DS, McCormack, J, Church, SH, Swafford, W, Drexler, K, Schuman, C, Ross, S, Wiest, K, Korthuis, PT, Lawson, W, Brigham, GS, Knox, PC, Dawes, M & Rotrosen, J 2016, 'Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: The Cocaine Use Reduction with Buprenorphine (CURB) study', Addiction, vol. 111, no. 8, pp. 1416-1427. https://doi.org/10.1111/add.13375
Ling, Walter ; Hillhouse, Maureen P. ; Saxon, Andrew J. ; Mooney, Larissa J. ; Thomas, Christie M. ; Ang, Alfonso ; Matthews, Abigail G. ; Hasson, Albert ; Annon, Jeffrey ; Sparenborg, Steve ; Liu, David S. ; McCormack, Jennifer ; Church, Sarah H. ; Swafford, William ; Drexler, Karen ; Schuman, Carolyn ; Ross, Stephen ; Wiest, Katharina ; Korthuis, P. Todd ; Lawson, William ; Brigham, Gregory S. ; Knox, Patricia C. ; Dawes, Michael ; Rotrosen, John. / Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence : The Cocaine Use Reduction with Buprenorphine (CURB) study. In: Addiction. 2016 ; Vol. 111, No. 8. pp. 1416-1427.
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abstract = "Aims: To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone {\circledR}) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol {\circledR}) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Methods: This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 g/day BUP (BUP4, n 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 02). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. Results: No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 (P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. Conclusions: Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.",
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T2 - The Cocaine Use Reduction with Buprenorphine (CURB) study

AU - Ling, Walter

AU - Hillhouse, Maureen P.

AU - Saxon, Andrew J.

AU - Mooney, Larissa J.

AU - Thomas, Christie M.

AU - Ang, Alfonso

AU - Matthews, Abigail G.

AU - Hasson, Albert

AU - Annon, Jeffrey

AU - Sparenborg, Steve

AU - Liu, David S.

AU - McCormack, Jennifer

AU - Church, Sarah H.

AU - Swafford, William

AU - Drexler, Karen

AU - Schuman, Carolyn

AU - Ross, Stephen

AU - Wiest, Katharina

AU - Korthuis, P. Todd

AU - Lawson, William

AU - Brigham, Gregory S.

AU - Knox, Patricia C.

AU - Dawes, Michael

AU - Rotrosen, John

PY - 2016/8/1

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N2 - Aims: To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone ®) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol ®) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Methods: This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 g/day BUP (BUP4, n 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 02). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. Results: No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 (P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. Conclusions: Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.

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KW - cocaine use disorder

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KW - multi-site trial

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KW - pharmacotherapy

KW - placebo-controlled

KW - treatment

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