NIDA chose a director and staff for the medications program and immediately began work. The highest priorities were to complete the testing of LAAM (levo-alpha acetyl methadol) for opioid maintenance and submit the data for FDA approval, find a medication that was useful in treating cocaine dependence, and continue studies of buprenorphine for opioid detoxification and maintenance. The importance of this effort was high due to the limited number of medications available to treat addiction, the size of the target populations, the limitations of currently available therapies, and the emergence of HIV disease along with data showing that addiction treatment reduced the chances for HIV infection (Avins et al., 1997; Metzger, Navaline, and Woody, 1998; Shoptaw et al., 1997; Woody et al., 2003).
Implicit in these efforts was the assumption that both the short- and long-term outcomes of addicted individuals could be improved with medication. This assumption was consistent with data showing that detoxification alone usually did not alter the long-term course of addiction, and with prior experience and data showing that some medications were safe and effective for specific indications.
Although the medications development program was anchored in the broader tradition of clinical drug testing and the need to meet FDA standards, many clinicians thought that treatment outcome was often maximized when medication was used in combination with psychosocial interventions such as counseling or psychotherapy (Resnick et al., 1981; Khantzian, 1985). The early methadone maintenance studies by Dole and Nyswander (1965) emphasized this point, as did the first FDA methadone regulations, and later studies confirmed it (McLellan et al., 1993). It was also clear that some addicted persons were able to achieve remission with psychosocial treatment alone (DeLeon, 1984; Hubbard et al., 1997) and that others remitted spontaneously or by attending self-help groups (Bailey and Leach, 1965). But despite their demonstrated benefits, it was clear that many addicted individuals failed to achieve optimal results with the current medications and drug-free treatments. The new program was simply an attempt to expand the available options by additional testing of medications that had shown promise, getting them approved by FDA, and finding new medications for addictions such as cocaine and other stimulant dependencies for which none currently existed.
The medications program has tested more than 50 pharmacotherapies for cocaine dependence and obtained FDA approval for LAAM, conducted studies that further documented the safety and efficacy of methadone maintenance, guided studies that contributed to the recent FDA approval of sublingual buprenorphine/naloxone (Suboxone) and buprenorphine (Subutex), facilitated the development of depot naltrexone for preventing