Buprenorphine maintenance treatment of opiate dependence: a multicenter, randomized clinical trial

Autor:	Joseph Collins, Doralie Segal, Laura McNicholas, Steve Batki, Donald R. Wesson, John A. Renner, Paul Casadonte, Donald J. Tusel, Prudencia C. Kintaudi, Lawrence S. Brown, Carol Fye, Charles Charuvastra, Susan M. Stine, Erick Santos, Walter Ling, Richard I. H. Wang, Usha Malkerneker
Rok vydání:	1998
Předmět:	Male medicine.medical_specialty Narcotic Antagonists Medicine (miscellaneous) Context (language use) law.invention Sublingual administration Double-Blind Method Randomized controlled trial law Internal medicine medicine Humans Adverse effect business.industry Opioid-Related Disorders Buprenorphine Clinical trial Psychiatry and Mental health Treatment Outcome Opioid Anesthesia Female Opiate business medicine.drug
Zdroj:	Addiction. 93:475-486
ISSN:	0965-2140
DOI:	10.1046/j.1360-0443.1998.9344753.x
Popis:	Aims. To evaluate the safety and ef® cacy of an 8 mg/day sublingual dose of buprenorphine in the maintenance treatment of heroin addicts by comparison with a 1 mg/day dose over a 16-week treatment period. As a secondary objective, outcomes were determined concurrently for patients treated with two other dose levels. Design. Patients were randomized to four dosage groups and treated double-blind. Setting. Twelve outpatient opiate maintenance treatment centers throughout the United States. Participants. Two hundred and thirty-nine women and 497 men who met the DSM-III-R criteria for opioid dependence and were seeking treatment. Intervention. Patients received either 1, 4, 8 or 16 mg/day of buprenorphine and were treated in the usual clinical context, including a 1-hour weekly clinical counseling session. Measurement. Retention in treatment, illicit opioid use as determined by urine toxicology, opioid craving and global ratings by patient and staff. Safety outcome measures were provided by clinical monitoring and by analysis of the reported adverse events. Findings. Outcomes in the 8 mg group were signi® cantly better than in the 1 mg group in all four ef® cacy domains. No deaths occurred in either group. The 8 mg group did not show an increase in the frequency of adverse events. Most reported adverse effects were those commonly seen in patients treated with opioids. Conclusions. The ® ndings support the safety and ef® cacy of buprenorphine and suggest that an adequate dose of buprenorphine will be a useful addition to pharmacotherapy.
Databáze:	OpenAIRE
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