TY - JOUR
T1 - Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence
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
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
N1 - Publisher Copyright:
© 2016 Society for the Study of Addiction.
PY - 2016/8/1
Y1 - 2016/8/1
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.
AB - 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.
KW - Buprenorphine + naloxone
KW - cocaine use disorder
KW - double-blind
KW - multi-site trial
KW - naltrexone
KW - pharmacotherapy
KW - placebo-controlled
KW - treatment
UR - http://www.scopus.com/inward/record.url?scp=84978152293&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84978152293&partnerID=8YFLogxK
U2 - 10.1111/add.13375
DO - 10.1111/add.13375
M3 - Article
C2 - 26948856
AN - SCOPUS:84978152293
SN - 0965-2140
VL - 111
SP - 1416
EP - 1427
JO - Addiction
JF - Addiction
IS - 8
ER -