Psychiatric News September 17, 2004
Volume 39 Number 18
© 2004 American Psychiatric Association
p. 33
Clarification
The article "Buprenorphine Depot Formulation Relieves Withdrawal
Symptoms" in the April 16 issue reporting on a study of the use of
buprenorphine in the treatment of dependence on both cocaine and heroin
contained information that the principal authors of the study believe could
mislead readers.
That article reported on the results of two research studies, the first of
which used an investigational depot formulation, and the second of which used
oral buprenorphine in patients with dual addiction. The headline captured the
focus of the first study, but not the second.
The story reported that the second study, "Randomized Trial of
Buprenorphine for Treatment of Concurrent Opiate and Cocaine
Dependence," by Ivan Montoya, M.D., M.P.H., and David Gorelick, M.D.,
Ph.D., both of the National Institute on Drug Abuse (NIDA), and their
colleagues investigated four dosing regimens of buprenorphine or placebo for
13 weeks. The study actually compared the four dosing regimens for a 10-week
trial of stable dosing, followed by a three-week taper, for a total study
period of 13 weeks. There was no placebo arm in the study; placebo was used in
one of the four dosing regimens studied, alternating with 16 mg of
buprenorphine every other day.
The story correctly reported the results of the study as group
means—echoing a NIDA press release on the study—implying that the
results correlated to decreases in the number of individuals using drugs and
the amount of drug used.
The results reported pertained to the percentages of all urine samples in
the group that were positive for drug and to urine drug concentrations across
all subjects, respectively. Although both percentages declined, as group
means, no inference about the status of drug use by individual subjects within
a given group can be drawn. Actual amount of drug used by individuals or the
group as a whole was not directly measured.
In addition, the story reported that "those taking 16 mg every other
day improved slightly, but generally less than those receiving 8 mg every
day." This conclusion was drawn from graphs of the data presented in the
article. However, the authors emphasized, as we noted, that this outcome was
not statistically significant.
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