Randomized trial of buprenorphine for treatment of concurrent opiate and cocaine dependence

Ivan D. Montoya, David A. Gorelick, Kenzie L. Preston, Jennifer R. Schroeder, Annie Umbricht, Lawrence J Cheskin, W. Robert Lange, Carlo Contoreggi, Rolley E. Johnson, Paul J. Fudala

Research output: Contribution to journalArticle

Abstract

Background: Buprenorphine is a partial μ-opiate agonist and κ-opiate antagonist with established efficacy in the treatment of opiate dependence. Its efficacy for cocaine dependence is uncertain. This study evaluated buprenorphine for the treatment of concomitant cocaine and opiate dependence. Methods: Two hundred outpatients currently dependent on both cocaine and opiates were randomly assigned to double-blind groups receiving a sublingual solution of buprenorphine (2, 8, or 16 mg daily, or 16 mg on alternate days, or placebo), plus weekly individual drug abuse counseling, for 13 weeks. The chief outcome measures were urine concentrations of opiate and cocaine metabolites (quantitative) and proportion of urine samples positive for opiates or cocaine (qualitative). Group differences were assessed by use of mixed regression modeling. Results: The target dose of buprenorphine was achieved in 179 subjects. Subjects receiving 8 or 16 mg buprenorphine daily showed statistically significant decreases in urine morphine levels (P = .0135 for 8 mg and P <.001 for 16 mg) or benzoylecgonine concentrations (P = . 0277 for 8 mg and P = .006 for 16 mg) during the maintenance phase of the study. For the 16-mg group, mean benzoylecgonine concentrations fell from 3715 ng/mL during baseline to 186 ng/mL during the withdrawal phase; mean morphine concentrations fell from 3311 ng/mL during baseline to 263 ng/mL during withdrawal. For the 8-mg group, mean benzoylecgonine concentrations fell from 6761 ng/mL during baseline to 676 ng/mL during withdrawal; mean morphine concentrations fell from 3890 ng/mL during baseline to 661 ng/mL during withdrawal. Qualitative urinalysis showed a similar pattern of results. Subjects receiving the highest dose showed concomitant decreases in both urine morphine and benzoylecgonine concentrations. There were no significant group differences in treatment retention or adverse events. Conclusions: A sublingual buprenorphine solution at 16 mg daily is well tolerated and effective in reducing concomitant opiate and cocaine use. The therapeutic effect on cocaine use appears independent of that on opiate use.

Original languageEnglish (US)
Pages (from-to)34-38
Number of pages5
JournalClinical Pharmacology and Therapeutics
Volume75
Issue number1
DOIs
StatePublished - Jan 2004
Externally publishedYes

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Opiate Alkaloids
Opioid-Related Disorders
Cocaine-Related Disorders
Buprenorphine
Cocaine
Morphine
Urine
Therapeutics
Urinalysis
Therapeutic Uses
Substance-Related Disorders
Counseling
Outpatients
Placebos
Maintenance
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Pharmacology

Cite this

Montoya, I. D., Gorelick, D. A., Preston, K. L., Schroeder, J. R., Umbricht, A., Cheskin, L. J., ... Fudala, P. J. (2004). Randomized trial of buprenorphine for treatment of concurrent opiate and cocaine dependence. Clinical Pharmacology and Therapeutics, 75(1), 34-38. https://doi.org/10.1016/j.clpt.2003.09.004

Randomized trial of buprenorphine for treatment of concurrent opiate and cocaine dependence. / Montoya, Ivan D.; Gorelick, David A.; Preston, Kenzie L.; Schroeder, Jennifer R.; Umbricht, Annie; Cheskin, Lawrence J; Lange, W. Robert; Contoreggi, Carlo; Johnson, Rolley E.; Fudala, Paul J.

In: Clinical Pharmacology and Therapeutics, Vol. 75, No. 1, 01.2004, p. 34-38.

Research output: Contribution to journalArticle

Montoya, ID, Gorelick, DA, Preston, KL, Schroeder, JR, Umbricht, A, Cheskin, LJ, Lange, WR, Contoreggi, C, Johnson, RE & Fudala, PJ 2004, 'Randomized trial of buprenorphine for treatment of concurrent opiate and cocaine dependence', Clinical Pharmacology and Therapeutics, vol. 75, no. 1, pp. 34-38. https://doi.org/10.1016/j.clpt.2003.09.004
Montoya, Ivan D. ; Gorelick, David A. ; Preston, Kenzie L. ; Schroeder, Jennifer R. ; Umbricht, Annie ; Cheskin, Lawrence J ; Lange, W. Robert ; Contoreggi, Carlo ; Johnson, Rolley E. ; Fudala, Paul J. / Randomized trial of buprenorphine for treatment of concurrent opiate and cocaine dependence. In: Clinical Pharmacology and Therapeutics. 2004 ; Vol. 75, No. 1. pp. 34-38.
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abstract = "Background: Buprenorphine is a partial μ-opiate agonist and κ-opiate antagonist with established efficacy in the treatment of opiate dependence. Its efficacy for cocaine dependence is uncertain. This study evaluated buprenorphine for the treatment of concomitant cocaine and opiate dependence. Methods: Two hundred outpatients currently dependent on both cocaine and opiates were randomly assigned to double-blind groups receiving a sublingual solution of buprenorphine (2, 8, or 16 mg daily, or 16 mg on alternate days, or placebo), plus weekly individual drug abuse counseling, for 13 weeks. The chief outcome measures were urine concentrations of opiate and cocaine metabolites (quantitative) and proportion of urine samples positive for opiates or cocaine (qualitative). Group differences were assessed by use of mixed regression modeling. Results: The target dose of buprenorphine was achieved in 179 subjects. Subjects receiving 8 or 16 mg buprenorphine daily showed statistically significant decreases in urine morphine levels (P = .0135 for 8 mg and P <.001 for 16 mg) or benzoylecgonine concentrations (P = . 0277 for 8 mg and P = .006 for 16 mg) during the maintenance phase of the study. For the 16-mg group, mean benzoylecgonine concentrations fell from 3715 ng/mL during baseline to 186 ng/mL during the withdrawal phase; mean morphine concentrations fell from 3311 ng/mL during baseline to 263 ng/mL during withdrawal. For the 8-mg group, mean benzoylecgonine concentrations fell from 6761 ng/mL during baseline to 676 ng/mL during withdrawal; mean morphine concentrations fell from 3890 ng/mL during baseline to 661 ng/mL during withdrawal. Qualitative urinalysis showed a similar pattern of results. Subjects receiving the highest dose showed concomitant decreases in both urine morphine and benzoylecgonine concentrations. There were no significant group differences in treatment retention or adverse events. Conclusions: A sublingual buprenorphine solution at 16 mg daily is well tolerated and effective in reducing concomitant opiate and cocaine use. The therapeutic effect on cocaine use appears independent of that on opiate use.",
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AU - Preston, Kenzie L.

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AU - Umbricht, Annie

AU - Cheskin, Lawrence J

AU - Lange, W. Robert

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N2 - Background: Buprenorphine is a partial μ-opiate agonist and κ-opiate antagonist with established efficacy in the treatment of opiate dependence. Its efficacy for cocaine dependence is uncertain. This study evaluated buprenorphine for the treatment of concomitant cocaine and opiate dependence. Methods: Two hundred outpatients currently dependent on both cocaine and opiates were randomly assigned to double-blind groups receiving a sublingual solution of buprenorphine (2, 8, or 16 mg daily, or 16 mg on alternate days, or placebo), plus weekly individual drug abuse counseling, for 13 weeks. The chief outcome measures were urine concentrations of opiate and cocaine metabolites (quantitative) and proportion of urine samples positive for opiates or cocaine (qualitative). Group differences were assessed by use of mixed regression modeling. Results: The target dose of buprenorphine was achieved in 179 subjects. Subjects receiving 8 or 16 mg buprenorphine daily showed statistically significant decreases in urine morphine levels (P = .0135 for 8 mg and P <.001 for 16 mg) or benzoylecgonine concentrations (P = . 0277 for 8 mg and P = .006 for 16 mg) during the maintenance phase of the study. For the 16-mg group, mean benzoylecgonine concentrations fell from 3715 ng/mL during baseline to 186 ng/mL during the withdrawal phase; mean morphine concentrations fell from 3311 ng/mL during baseline to 263 ng/mL during withdrawal. For the 8-mg group, mean benzoylecgonine concentrations fell from 6761 ng/mL during baseline to 676 ng/mL during withdrawal; mean morphine concentrations fell from 3890 ng/mL during baseline to 661 ng/mL during withdrawal. Qualitative urinalysis showed a similar pattern of results. Subjects receiving the highest dose showed concomitant decreases in both urine morphine and benzoylecgonine concentrations. There were no significant group differences in treatment retention or adverse events. Conclusions: A sublingual buprenorphine solution at 16 mg daily is well tolerated and effective in reducing concomitant opiate and cocaine use. The therapeutic effect on cocaine use appears independent of that on opiate use.

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