Federal government officials, members of Congress, addiction treatment specialists, and patients addicted to heroin all agree. Buprenorphine is about to revolutionize the treatment of opiate addiction in the United States.

Congress layed the groundwork in July with the Drug Addiction Treatment Act of 2000, authorizing the use of buprenorphine as a controlled substance to treat opiate addiction. Now the Substance Abuse and Mental Health Services Administration’s Center for Substance Abuse Treatment (CSAT) is busy writing treatment guidelines and prescribing regulations in anticipation of the U. S. Food and Drug Administration (FDA) granting final approval for buprenorphine’s use in addiction treatment. The medication will be available in tablet form alone and in combination with naloxone.

Already considered "approvable" by the FDA, final approval for the designated "orphan drug" is expected later this year.

Buprenorphine is a partial opiate agonist, chemically related to morphine; however, it possesses both agonist and antagonist properties. Available in the U.S. in injectable form under the trade name Buprenex for more than 20 years, buprenorphine has undergone extensive testing in addiction treatment only in the last five years. Partial agonists possess ceiling effects; that is, increasing the dose will only have increasing effects up to a known, finite level. As such, partial agonists are considered to be safer than full agonists such as heroin or morphine, because they have lower potential to depress the respiratory reflex and lower potential for dependence.

With the addition of naloxone, a known opiate antagonist, to buprenorphine in a tablet formulation, the new medication will be difficult to abuse. When the drug is illicitly dissolved and injected, an addicted individual will likely experience withdrawal, or at best, a diminished buprenorphine effect.

This improved safety profile, when compared with currently available opiate addiction treatments such as methadone or LAAM will allow the buprenorphine/naloxone tablet to be prescribed in an outpatient, office setting. Several studies, funded by the National Institute on Drug Abuse (NIDA) have shown buprenorphine to be more effective than a low dose of methadone and that a direct dose-related effect exists between buprenorphine and reduction of opiate use.

Both methadone and LAAM are severely restricted for use only in highly regulated inpatient and clinic settings. The availability of buprenorphine in an outpatient, private office setting, where an individual makes an appointment with their physician and leaves with a prescription to take to the pharmacy, could completely change the environment of drug-addiction treatment.

H. Westley Clark, M.D., director of CSAT, notes that opiate addiction is currently sharply rising in the U.S. According to the National Household Survey on Drug Abuse, in 1997 there were an estimated 2.4 million Americans who reported using heroin at some point in their lives. In 1996, Clark says, America showed the highest number of new opiate users, 171,000, in 30 years. "CSAT’s latest Treatment Episode Data Set (TEDS) 1992 through 1997," Clark says, "revealed that the number of opiate—primarily heroin—admissions surpassed cocaine admissions in 1997."

Clark strongly agrees with officials at NIDA, however, that "counseling, individual and/or group, and other behavioral therapies are critical components of effective treatment for addiction. This is not going to change even if new medications such as buprenorphine become available." However, Clark added, part of CSAT’s response to public health concerns is to "ensure availability of effective treatments earlier in the course of addiction than has previously been the practice. We need drug treatments that can be utilized by primary care physicians as well as addiction medicine practitioners in private practice."

President Bill Clinton is expected to sign the Drug Addiction Treatment Act of 2000 following minor changes by Congress during a conference committee, and final approval of buprenorphine by the FDA is expected in the coming months. Now, CSAT must come up with regulations and standards to allow buprenorphine’s use by prescription as a schedule IV controlled substance.

According to CSAT’s Clark, the partial agonist treatment guidelines are likely to include:

• standards for determining the training and experience necessary to safely and effectively treat opiate addicts with the anticipated medications;

• limits in the number of patients that may be treated by any one office-based physician;

• standards relating to medical and psychosocial services, including counseling, that should be available to patients;

• potential limits on the quantities of medications that may be prescribed.

The process for creating the guidelines is already underway, said Clark. A panel of experts has been formed to prepare draft guidelines using the CSAT consensus process. "These guidelines will serve as the ‘best practice’ standards for treatment," Clark said, "providing a valuable reference to physicians and complementing the regulations."

Clark expects buprenorphine to become a valuable tool in treating heroin addiction; however, he does not expect it to replace methadone. As such, CSAT is also looking at a new system that would replace the strictly regulated methadone programs currently in place.