a promising new anti-addiction treatment medication currently
under review for approval by the Food and Drug Administration
(FDA), is expected to be the first opioid treatment medication
available for administration by primary-care physicians and
specialists in their own offices.
Susanne Caviness, Ph.D. (Capt., U.S. Public Health Service),
of SAMHSA's Center for Substance Abuse Treatment (CSAT)
explains, "Office-based opioid treatment is very promising.
For example, a knowledgeable family physician who has cared
for a patient over a period of years could detect early signs
of drug addiction. Then the physician can quickly intervene
with appropriate medication and counseling. The result would
be more continuity of care since the patient would not have
to be referred to a community clinic for separate addiction
Although the FDA had not yet approved buprenorphine at the
time SAMHSA News went to press, approval is anticipated
before the end of 2002.
Buprenorphine is similar to full agonist medications such
as methadone and LAAM in two ways:
- It reduces cravings for illicit opiates and suppresses
the opiate abstinence withdrawal syndrome.
- It produces morphine-like subjective effects and cross-tolerance
to other opiates.
However, buprenorphine has a ceiling effect. Dosages above
a certain amount do not produce corresponding increases in
effect. Thus, for certain pharmacologic effects, e.g., respiratory
depression, buprenorphine may be safer in some ways than methadone
and LAAM. It offers lower abuse potential, relatively mild
withdrawal symptoms, and effectiveness for some patients with
dosing only 3 times per week.
Although buprenorphine will not replace methadone, it provides
yet another alternative in the treatment of opiate addiction—particularly
for maintenance therapy.
While FDA's role is to approve the use of buprenorphine,
SAMHSA's role is to approve waiver nominations for office-based
physicians to dispense or prescribe it. The Drug Addiction
Treatment Act of 2000 permits qualified physicians to seek
a waiver from the Federal requirement to obtain the separate
registration that is necessary for methadone treatment programs.
The waiver nominations are submitted to SAMHSA. CSAT is already
processing and evaluating submissions for waivers, which will
be issued once buprenorphine is approved by FDA.
To obtain such a waiver, licensed physicians must be qualified
either through subspecialty board certification or completion
of training in treatment and management of opiate-dependent
patients. SAMHSA is funding onsite and online training in
office-based opioid treatment, currently available through
the American Psychiatric Association, American Academy of
Addiction Psychiatry, American Osteopathic Association, and
the American Society of Addiction Medicine.
CSAT worked with the Federation of State Medical Boards,
representing 68 states and territories, to develop buprenorphine
clinical practice guidelines. The guidelines should help physicians
make practical decisions in treating patients with this medication.
Practitioners throughout the Nation are enthusiastic about
the prospect of office-based opioid treatment with buprenorphine,
according to CSAT's Division of Pharmacologic Therapies
Director Robert Lubran, M.S., M.P.A.
For more information, go to buprenorphine.samhsa.gov.
Or contact the CSAT Buprenorphine Information Center via e-mail
or by telephone at 1 (866) BUP-CSAT (287-2728). Operators
are available to answer calls Monday through Friday from 8:30
a.m. to 5 p.m., Eastern Time.