Abstract | BACKGROUND: 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:
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Authors | 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 |
Journal | Clinical pharmacology and therapeutics
(Clin Pharmacol Ther)
Vol. 75
Issue 1
Pg. 34-48
(Jan 2004)
ISSN: 0009-9236 [Print] United States |
PMID | 14749690
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Narcotic Antagonists
- Buprenorphine
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Topics |
- Administration, Sublingual
- Adult
- Buprenorphine
(administration & dosage, therapeutic use)
- Cocaine-Related Disorders
(complications, drug therapy, urine)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Male
- Narcotic Antagonists
(administration & dosage, therapeutic use)
- Opioid-Related Disorders
(complications, drug therapy, urine)
- Patient Compliance
- Treatment Outcome
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