Office-Based Treatment of Opiate Addiction With a Sublingual-Tablet Formulation of Buprenorphine and Naloxone

• NCJ Number: 253640
• Journal: New England Journal of Medicine Volume: 349 Issue: 10 Dated: September 2003 Pages: 949-956
• Author(s): Paul J. Fudala; T. Peter Bridge; Susan Herbert; William O. Williford; C. N. Chiang; Karen Jones; Joseph Collins; Dennis Raisch; Paul Casadonte; R, Jeffrey Goldsmith; Walter Ling; Usha Malkerneker; Laura McNicholas; John Renner; Susan Stine; Donald Tusel
• Date Published: September 2003
• Length: 8 pages
• Publication Format: Article
• Publication Type: Research (Applied/Empirical); Report (Study/Research); Program/Project Evaluation; Program/Project Description
• Language: English
• Country: United States of America

Annotation

Since office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone has been proposed, but its efficacy and safety have not been well studied, the current study conducted a multicenter, randomized, placebo-controlled trial that involved 326 opiate-addicted persons who were assigned to office-based treatment with sublingual tablets consisting of buprenorphine (16 mg) in combination with naloxone (4 mg), buprenorphine alone (16 mg), or a placebo given daily for 4 weeks.

Abstract

The double-blind trial was terminated early because buprenorphine and naloxone in combination and buprenorphine alone were found to have greater efficacy than placebo. The proportion of urine samples that were negative for opiates was greater in the combined-treatment and buprenorphine groups (17.8 percent and 20.7 percent, respectively) than in the placebo group (5.8 percent, P<0.001 for both comparisons); the active-treatment groups also reported less opiate craving (P<0.001 for both comparisons with placebo). Rates of adverse events were similar in the active-treatment and placebo groups. During the open-label phase, the percentage of urine samples negative for opiates ranged from 35.2 percent to 67.4 percent. Results from the open-label follow-up study indicated that the combined treatment was safe and well tolerated. The study's overall conclusion is that buprenorphine and naloxone in combination and buprenorphine alone are safe and reduce the use of opiates and the craving for opiates among opiate-addicted persons who receive these medications in an office-based setting. (publisher abstract modified)