A Randomized Controlled Trial of Auricular Acupuncture for Cocaine
Dependence
S. Kelly Avants, PhD; Arthur Margolin, PhD; Theodore R. Holford, PhD; Thomas R. Kosten, MD
Background Partly because of a lack of a conventional, effective treatment for
cocaine addiction, auricular acupuncture is used to treat this disorder in
numerous drug treatment facilities across the country for both primary cocaine-dependent
and opiate-dependent populations.
Objective To evaluate the effectiveness of auricular acupuncture for the treatment
of cocaine addiction.
Methods Eighty-two cocaine-dependent, methadone-maintained patients were randomly
assigned to 1 of 3 conditions: auricular acupuncture, a needle-insertion control
condition, or a no-needle relaxation control. Treatment sessions were provided
5 times weekly for 8 weeks. The primary outcome was cocaine use assessed by
3-times-weekly urine toxicology screens.
Results Longitudinal analysis of the urine data for the intent-to-treat sample
showed that patients assigned to acupuncture were significantly more likely
to provide cocaine-negative urine samples relative to both the relaxation
control (odds ratio, 3.41; 95% confidence interval, 1.33-8.72; P = .01) and the needle-insertion control (odds ratio, 2.40; 95% confidence
interval, 1.00-5.75; P = .05).
Conclusions Findings from the current study suggest that acupuncture shows promise
for the treatment of cocaine dependence. Further investigation of this treatment
modality appears to be warranted.
Arch Intern Med. 2000;160:2305-2312
USE OF cocaine continues to be a serious problem in the United States.
The 1998 National Household Survey on Drug Abuse reported 1.8 million current
users, with a significant increase in use among those aged 18 to 25 years
relative to the previous year.1 At present,
there are few conventional treatments with demonstrated efficacy available
for the treatment of this disorder. Given the lack of conventional treatments,
an alternative therapy
auricular acupuncture, as codified by the National
Acupuncture Detoxification Association (NADA)2is
in widespread use in drug treatment facilities across the country.3 Although a number of preliminary studies investigating
the effectiveness of acupuncture for the treatment of cocaine addiction have
reported positive results,4 findings from controlled
studies have to date been inconclusive, with some studies reporting positive
treatment effects for acupuncture,5-7
while others have reported finding no difference between acupuncture and controls.8-12
One impediment to determining the effectiveness of auricular acupuncture
stems from the complexity of investigating this treatment modality in controlled
studies.13, 14 Acupuncture is a
procedure, and developing controls for procedures and testing them under blinded
conditions offers numerous problems.15, 16
In planning the current study, we deemed it important to control for both
nonspecific factors, such as monitoring of drug use, completion of questionnaires,
and staff attention, and specific factors that necessarily attend an acupuncture
treatment and that may confound interpretation of findings.17
For example, acupuncture treatments typically involve patients reposing in
a quiet setting under relaxing conditions. Because relaxation has been associated
with reduced drug craving,18, 19
which may in turn reduce drug use and have other beneficial effects independent
of any presumed acupuncture effects, a nonneedle relaxation protocol was developed
to control for these nonspecific effects of acupuncture treatments.
In addition to possible relaxation effects induced by the treatment
context, insertion of needles into the body is a potentially impressive ritual
that may elicit a beneficial placebo response in drug users, independent of
an acupuncture-specific mechanism.20 To control
for this aspect of the acupuncture treatment, acupuncture studies have used
needle insertion into "sham" points, usually stipu lated a priori as such,
eg, points proximate to active points.8, 12
However, these points may be too active to be suitable controls.21
On the basis of several studies of acute effects conducted by our research
group, we provisionally concluded that needles inserted into regions on the
helix of the auricle were relatively less active than other potential control
needle configurations tested, and therefore would constitute an appropriate
control for needle insertion.21-23
Herein we report on a randomized clinical trial conducted to determine
the efficacy of auricular acupuncture for the treatment of cocaine dependence
in methadone-maintained patients with the use of the 2 control procedures
previously outlined. This patient population was selected because cocaine
use is a serious problem in methadone maintenance programs (MMPs) across the
country,24 and thus a community-based MMP provided
a pertinent treatment context in which to evaluate auricular acupuncture's
efficacy with a relatively difficult-to-treat patient population. The primary
outcome for this study was an objective measure of cocaine use based on frequent
urine toxicology screens.
PATIENTS AND METHODS
PARTICIPANTS
Participants were 82 cocaine- and opioid-dependent patients enrolled
in an inner-city MMP who were referred to the study because of their unremitting
cocaine use. This sample size was projected to provide sufficient power (0.80)
to detect a moderate to large treatment effect (0.35) among the treatment
conditions. The research protocol was approved by the Human Investigation
Committee of Yale University School of Medicine, New Haven, Conn, and all
participants provided signed informed consent to participate in the study.
ENTRANCE AND DISCONTINUATION CRITERIA
Inclusion criteria were (1) age of at least 18 years; (2) enrollment
in an MMP and maintenance on a stable dose of methadone; (3) meeting criteria
for cocaine dependence according to the Structured Clinical Interview for DSM-IV25; and (4) evidence
of recent cocaine use, as follows: (a) provision
of a cocaine-positive urine screen at time of screening; (b) self-reported cocaine use the week before screening; or (c) provision of cocaine-positive urine screen within 2 weeks before
screening. Exclusion criteria were as follows: (1) dependence on any substance
other than opiates, cocaine, or nicotine; (2) current treatment for cocaine
dependence; (3) current use of a psychotropic medication, unless maintained
on a regimen of this medication for at least 90 days; (4) current acupuncture
treatment or use of acupuncture in the previous 30 days; and (5) active suicidal
or psychotic status. The intent-to-treat sample included all patients who
were randomly assigned to treatment. Patients who failed to attend 3 of the
first 8 sessions, as well as those who attended less than 1 session per week
thereafter, were discontinued from the study and coded as noncompleters.
RANDOMIZATION
After completion of each patient's screening and intake interviews,
a staff member generated the treatment assignment for that patient by means
of a computer-based, randomization procedure,26
programmed to balance the conditions on sex, race, and human immunodeficiency
virus serostatus. In an orientation session, patients were informed of their
treatment assignment, and the treatment was described by means of a standardized
script. To enhance the credibility of the control conditions, patients were
encouraged to view all of the study treatments as ways to reduce stress, with
attendant benefits. Patients assigned to relaxation were additionally provided
with instruction concerning the relaxation protocol to be provided. Treatment
commenced on the Monday after randomization. The flow diagram in Figure 1 illustrates the patients' progress
through the trial.
TREATMENT CONDITIONS
NADA Auricular Acupuncture Protocol
As originally formulated, the NADA protocol specified needle insertion
into 5 auricular zones; however, as practiced clinically, the number of needles
inserted bilaterally ranges from 3 to 5. In the current study, needles were
inserted into the auricles bilaterally at 4 NADA-specified zones: sympathetic, located in the deltoid fossa at the junction of the infra-antihelix
crus and the medial order of the helix; lung, located
in the center of the cavum concha; liver, located
in the posterior to upper portion of the helix crus; and shen men, located in the inferior corner of the bifurcating point of
the antihelix. Needles were inserted into the cartilage at each point such
that they were perpendicular to the surface of the ear, and entered the cartilage
to a depth of between 1 and 3 mm. Needles were 0.20 mm wide and 15 mm long,
stainless steel, and disposable; sterilized with ethylene oxide gas; and individually
packaged in sterile containers (Seirin Co Ltd, Shimizu-City, Japan).
Auricular Needle-Insertion Control Condition
Four needles of the same type and size used for the active acupuncture
treatment were inserted into the helix of the auricles bilaterally at 3 zones
not commonly used for the treatment of any disorder. Two needles were inserted
into zone 1, located on the helix from the high point of the helix to just
above the superior border of Darwin's tubercle, on the anteroposterior dividing
line border of the auricule; 1 needle was inserted into zone 2, located on
the helix at the level of Darwin's tubercle, from just below the superior
order of the tubercle to just above the inferior order of the tubercle, on
the anteroposterior dividing line border of the auricle; and 1 needle was
inserted into zone 3, located from just below the inferior order of Darwin's
tubercle to approximately level with the end of the crus of the helix, on
the anteroposterior dividing line border of the auricle. To further minimize
the possibility of providing an active treatment, care was taken not to insert
needles in the "liver Yang" points, which are located near these regions.
Furthermore, needles were not inserted into the cartilage at each point; rather,
they were inserted subcutaneously, at an oblique angle.
Relaxation Control Condition
This condition consisted of viewing commercially available videos, on
a large-screen (30-inch [76.2 cm]) television, depicting relaxation strategies
that had been described during orientation, as well as relaxing visual imagery
(eg, nature scenes) and music. For variety, 3 different videos were shown
each week on a preestablished schedule.
In all 3 conditions, treatment was delivered for 40 minutes each weekday
(Monday through Friday) for 8 weeks, after receipt of the daily methadone
dose. Patients were instructed to attend treatment daily and were informed
of the consequences for nonattendance. No financial incentives were provided
for attendance. Treatments were delivered in groups of up to 6 patients, in
the same treatment room, and under the same conditions (eg, while recumbent
in a reclining chair), but at different times, such that patients in different
treatment conditions were not treated together. Patients assigned to the 2
needle-insertion conditions were unaware of whether they were receiving the
NADA protocol. All 3 treatment conditions were provided by a professional
acupuncturist (Stephen Birch, PhD) who had more than 10 years' experience
as an acupuncturist, acupuncture instructor, and acupuncture scholar, and
who was certified to provide the NADA protocol. Patients were informed that
the acupuncturist-relaxation trainer was not permitted to engage them
in conversation, and patients were instructed not to converse with one another
during the session. All sessions were provided with the use of a standardized
script, under the observation of a research assistant.
ASSESSMENTS
Urine samples were collected 3 times weekly (Monday, Wednesday, and
Friday) while the patient remained in treatment and were tested for the presence
of cocaine metabolite (benzoylecognine) using fluorescence polarizatyion immunoassay
(TDx; Abbott Laboratories, Abbott Park, Ill), which has been shown to be a
reliable and precise assay.27 Samples with
benzoylecognine levels of 300 ng/mL or more were considered positive for cocaine.
For the range of doses between 13 and 130 mg of topically used cocaine, the
test result will remain positive for at least 3 days after cocaine use. This
is a clinically reasonable sensitivity for illicit cocaine use by either topical
(ie, nasal), freebase, or intravenous routes. The Addiction Severity Index
(ASI),28 the Treatment Credibility Scale,29 and the Stages of Change Readiness and Treatment
Eagerness Scale (SOCRATES Version 8D)30 were
administered before treatment (ie, at entry into the trial) and at the end
of the 8-week trial (ie, at the 8-week follow-up). The ASI is a structured
interview commonly used in addiction research that provides composite scores
assessing the severity of 7 addiction-related problem areas. The Treatment
Credibility Scale is a 5-item questionnaire that assesses confidence in treatment
for the target disorder on scales from 1 (not at all) to 6 (very confident);
items were averaged to provide a single treatment credibility score (Cronbach 
= .88). The SOCRATES is a 19-item questionnaire assessing readiness for substance
abuse treatment. Items are rated on scales from 1 (strongly disagree) to 5
(strongly agree), and 3 composite scores are calculated ( values range
from .60 to .96). An overall treatment readiness score was calculated by subtracting
the "ambivalence" score from the sum of the "problem recognition" and "taking
action" scores. A 10-item assessment of therapeutic alliance with the acupuncturist-relaxation
trainer, modified from the therapeutic alliance scale,31
was administered at the end of the first treatment session and again in weeks
4 and 8. Items were rated on 7-point scales from 1 (never) to 7 (always) and
averaged (Cronbach = .92). Acute subjective effects of treatment sessions
were assessed weekly on 5-point scales from 0 (not at all) to 4 (extreme),
as follows: (1) 5 items assessed pain (ie, pain in ears on needle insertion
and pain at needle sites during session) and de qi-associated
sensations (ie, warmth in ears, activity in ears, and radiating sensations
from ears to face, neck, or shoulders); (2) 5 items assessed relaxation effects
relative to presession levels (eg, relaxed, heaviness, warmth, sleepiness,
looser muscles); (3) 5 items assessed satisfaction with the session (eg, session
enjoyment, stress reduction, feelings of happiness and peacefulness, and increased
confidence in acupuncture as a treatment for cocaine problems); (4) as an
additional measure of treatment desirability, participants were asked how
much they would be willing to pay for such a treatment session in the future
(nothing, $5, $10, $15, $20); and (5) as a measure of duration of treatment
effects, 1 item, asked the following day, asked how long the previous session's
effects lasted (0 indicated no effect; 1, less than 1 hour; 2, 2-3 hours;
3, all afternoon; and 4, all night). As in previous studies,32
items in each category were averaged.
DATA ANALYTIC STRATEGY
The Kaplan-Meier method and log-rank test were used to compare the survival
time to dropout. Differential retention by treatment condition on pretreatment
sociodemographic and drug use variables, and on perceived treatment credibility,
therapeutic alliance, and acute effects of treatment, was examined by means
of a series of 3 (treatment condition) 
2 (retention status) analyses
of variance (ANOVAs) on continuous variables and 
2 analyses
by treatment condition and retention status for categorical variables.
Primary treatment outcome analysis was conducted on the intent-to-treat
sample. The treatment outcome of primary interest was assessed by 3-times-weekly
urine toxicology screens, each of which was coded as a binary response (0,
negative; 1, positive). A generalized linear model for longitudinal data was
fitted to the data33 by means of a marginal
model. PROC GENMOD in SAS34 was used for the
analysis. Baseline urine data (ie, the screening urine test) did not fit smoothly
with the observations subsequently taken during treatment and would have required
a separate parameter for each treatment condition, thus effectively removing
the baseline observations from the tests for treatment effect; therefore,
analyses were limited to the thrice-weekly urine screens provided during the
course of treatment. The succession of 24 urine toxicology screens constituted
the time parameter and were treated as equally spaced.33(p75)
Parameters were estimated by means of generalized estimating equations, and
the resulting empirical variances were used for statistical inference. Our
analytic strategy was first to determine the underlying structure of the correlation
between the repeated urine tests by constructing a variogram for the residuals
about the proportion that tested positive by treatment condition and time.
On the basis of examination of this variogram, which indicated serial correlation
among urine test results, an autoregressive, AR(1), covariance structure was
used in subsequent analyses. From the unstructured or saturated model, the
serial correlation was estimated to be 0.62d, where d is the difference between urine screen index numbers.
Estimates of treatment time effects were then used to select an appropriate
model or equation that would accurately describe the time trend for each treatment
condition. Finally, significance tests of the model were constructed to compare
the acupuncture-treated group with each of the 2 control conditions, as well
as to obtain an overall test of any differences among the groups. This was
accomplished by constructing a Wald test35
for a linear contrast that would address the null hypothesis posed by a particular
comparison. The resulting statistics were then compared with a 2 distribution with the appropriate degrees of freedom. The empirical
covariance of the parameter estimates was used in constructing this test.
Secondary analyses included analysis of urine data provided by the sample
of treatment completers. The number of consecutive cocaine-negative urine
samples provided by each treatment completer was calculated, with missed urine
samples coded as cocaine positive. These data were entered into ANOVA with
planned treatment contrasts. To determine abstinence status at completion
of treatment, 2 analyses were conducted by treatment condition
on percentage of completers who provided 3 consecutive cocaine-negative urine
samples during week 8. Change in ASI severity of addiction and SOCRATES motivation
scores by treatment condition were also assessed by 3 (group) 2 (time)
mixed ANOVAs. Data are given as mean 
SD, unless otherwise indicated.
RESULTS
PATIENT CHARACTERISTICS
The mean age of the sample was 37 6 years; 47 (57%) were men
and 35 (43%) were women; 36 (44%) were white, 31 (38%) were African American,
13 (16%) were Hispanic, and 2 (2%) identified themselves as "other" minority;
35 (43%) had less than high school education; and 74 (90%) were unemployed.
All patients had reached a stable dose of methadone; mean methadone dose during
the trial was 78 17 mg/d.
RETENTION
Eighty-two patients were randomly assigned to a treatment condition
and constitute the intent-to-treat sample. Sixty-three percent of these patients
completed the 8-week trial; 46% (13/28) completed auricular acupuncture, 63%
(17/27) completed the needle-insertion control, and 81% (22/27) completed
the relaxation control. Thus, 52 patients constituted the sample who completed
the study. There was a significant difference in survival time in the study
(auricular acupuncture, 5.2 3.0 weeks; needle-insertion control,
6.7 2.5 weeks; relaxation control, 7.0 2.3 weeks; log-rank 22 = 7.84; P = .02). Patients assigned
to acupuncture completed significantly fewer treatment weeks than patients
assigned to either of the 2 control conditions. There were no significant
pretreatment between-group differences on any measured variable, and no significant
interactions between retention status and treatment condition. Table 1 provides a description of the sample by treatment condition
and retention status.
PRIMARY ANALYSIS OF INTENT-TO-TREAT SAMPLE: COCAINE USE DURING TREATMENT
There were no pretreatment differences among the treatment conditions
on cocaine use during the week before patients entered the trial. For the
baseline measurement, 93% (26/28) of the acupuncture group, 100% (27/27) of
the needle control group, and 93% (25/27) of the relaxation control group
had used cocaine in the week before beginning treatment. The logistic regression
parameters for each treatment-time combination for subsequent urine toxicology
results during the 8-week trial for the intent-to-treat sample are shown in Figure 2. Inspection of the pattern suggested
that a break in the line occurred at approximately urine screen 15, and that
using a broken line model as a final summary would simplify the observed time
pattern and would more accurately characterize the observed trend with time.
A formal test suggests that this is indeed the case (22 = 0.09; P = .95). The fitted lines for the
proportion of cocaine-positive urine tests in each treatment condition are
also shown in Figure 2.
The data provide strong evidence for differences among the 3 conditions
on the basis of a global test of the null hypothesis that both intercepts
and slopes are identical (24 = 12.91; P = .01). This is a test of the null hypothesis that the 3 fitted lines
in Figure 2 are coincident. Because
the trend lines appear to be similar, and a formal test suggested parallel
trends (22 = 5.29; P =
.07), subsequent comparisons among conditions were made by means of a parallel
trends model. This approach generally leads to a more powerful test because
it is directed at a single parameter instead of 2. The comparison of acupuncture
with relaxation was significant (21 = 6.54; P = .01), with an estimated overall odds ratio for a cocaine-negative
urine screen of 3.41 (95% confidence interval [CI], 1.33-8.72). The comparison
of acupuncture with needle control was also significant (21 = 3.83; P = .05), with an estimated overall
odds ratio for a cocaine-negative urine screen of 2.40 (95% CI, 1.00-5.75).
Patients randomly assigned to receive the NADA acupuncture protocol were more
likely to provide cocaine-negative urine samples than either the needle-insertion
or relaxation controls.
One assumption of the analysis presented above is that data are missing
at random in all conditions (ie, the reason an observation was missing was
not somehow related to whether an individual previously tested positive for
cocaine use). To test this, we examined the relationship between missing data
and provision of positive urine screens. The association between whether a
test was positive at one visit and missing at the next was analyzed by creating
a series of 2 2 tables for each urine screen. The Cochran-Mantel-Haenszel
test was not significant for the overall association across screens (21 = 0.08; P = .77). Within each
condition, the estimated common odds ratios for the association between a
positive test result and missing data across screens were 1.55 (95% CI, 0.8-3.1)
for acupuncture, 0.8 (95% CI, 0.4-1.5) for the needle control group, and 1.1
(95% CI, 0.5-2.9) for the relaxation control group.
The fact that the acupuncture group had a lower retention rate and therefore
provided fewer urine samples than either of the control groups (acupuncture,
15.25 8.12; needle control, 19.07 6.19; relaxation, 19.96
5.91; F2,79 = 3.72; P = .03)
also raises the issue of whether the apparent effectiveness of acupuncture
was mainly a function of treatment nonresponders differentially dropping out
of this condition. To test this, we conducted a 2 (retention status)
3 (treatment condition) ANOVA on percentage of urine samples testing positive
for cocaine. There was no significant retention treatment condition
interaction (noncompleters: acupuncture, 80.7 32.3; needle-insertion
control, 89.4 15.3; relaxation control, 80.0 34.6; completers:
acupuncture, 49.5 33.0; needle-insertion control, 71.1 33.2;
relaxation control, 80.5 28.0; F2,76 = 1.43; P = .25). Thus, noncompleters were generally comparable across conditions.
SECONDARY ANALYSIS OF OUTCOMES FOR TREATMENT COMPLETERS: CONSECUTIVE
COCAINE-NEGATIVE URINE SCREENS AND STATUS AT TREATMENT COMPLETION
Examination of urine data for patients who completed the 8-week trial
showed that acupuncture completers provided significantly more consecutive
cocaine-negative urine samples than did either the relaxation control group
(P = .002) or the needle-insertion control group
(P = .02) (acupuncture, 7.23 6.77; needle-insertion
control, 3.35 3.55; relaxation control, 2.14 3.37; F2,49 = 5.37; P = .008). Acupuncture completers
were also significantly more likely to provide 3 consecutive cocaine-free
urine samples in the final week of the study (acupuncture, 54% [7/13]; needle-insertion
control, 24% [4/17]; relaxation control, 9% [2/22]; 22 = 8.76; P = .01).
ADDITIONAL TREATMENT OUTCOMES
There was a main effect for time for severity of drug problems as measured
by the ASI, which, collapsed across treatment conditions, decreased significantly
from pretreatment to the 8-week follow-up (F1,61 = 5.59; P = .02). There were no other changes in ASI or SOCRATES
scores across time and no significant treatment condition time interactions.
CHECKS ON INTEGRITY OF THE TREATMENT CONDITIONS
Session Attendance
There was no significant difference among the treatment conditions in
average number of sessions attended per week while retained in treatment.
For the intent-to-treat sample, the average number of sessions attended per
week was as follows: acupuncture, 3.1 1.1; needle-insertion control,
3.3 0.8; and relaxation control, 3.6 0.6 (F2,79
= 2.05; P = .14). For the completers, average number
of sessions attended per week was as follows: acupuncture, 3.6 1.0;
needle-insertion control, 3.7 0.6; relaxation control, 3.7
0.6 (F2,49 = 0.04; P = .96). Thus, session
attendance was not greater in the acupuncture treatment condition and was
generally comparable across treatment conditions.
Acute Effects of Treatment Sessions
Relaxation controls reported significantly more relaxation effects after
sessions than did patients assigned to either type of needle insertion (F2,76 = 6.00; P = .004). There were no significant
differences between the 3 treatment conditions in ratings of satisfaction
with sessions, duration of treatment effects, or willingness to pay for future
sessions. Comparisons between the 2 needle-insertion conditions disclosed
no significant differences on ratings of pain or de qi
sensations.
Treatment Credibility and Therapeutic Alliance
There was no difference by treatment condition on either treatment credibility
or therapeutic alliance either at pretreatment or at the 8-week follow-up.
There was no significant change in these scores during treatment, nor was
there a significant treatment condition time interaction. Table 2 presents mean scores collapsed
across time. As shown, patients in each condition found the treatment protocols
to be credible and reported a positive therapeutic alliance with the acupuncturist-relaxation
trainer.
Relationship Between Acute Response to Treatment Sessions and Treatment
Retention
There were no significant differences in any of the previously described
measures by retention status, and no significant treatment condition
retention interactions. Table 2
presents mean (SD) ratings during the 8-week trial by treatment condition
and retention status.
COMMENT
Intent-to-treat analysis of longitudinal urine toxicology data indicated
that the NADA auricular acupuncture protocol was significantly more effective
in reducing cocaine use than either a relaxation control (P = .01) or a needle-insertion control (P
= .05). Analysis of data for treatment completers showed that patients who
completed the 8-week course of acupuncture abstained from cocaine significantly
longer during treatment and were more likely to be abstinent at completion
than either of the control conditions (P<.05).
The finding of a positive clinical response to acupuncture is generally
consistent with preliminary studies suggesting that the NADA acupuncture protocol
shows promise for the treatment of cocaine abuse.4-12, 36
Failure of previous controlled trials to demonstrate a significant difference
between the NADA protocol and a needle-insertion control may have resulted
from insufficient differentiation between the active and control conditions.
Previous controls have included needle insertion into presumably "inactive"
sites proximate to addiction-specific sites, or into "active" sites used for
the treatment of other disorders. The needle-insertion control used in the
current studyinsertion into helix sitesmay have provided sufficient
differentiation to detect a statistically significant difference relative
to the active treatment. However, the difference in treatment response between
the NADA protocol and the needle-insertion control was smaller than that found
between the NADA protocol and the no-needle relaxation control condition,
suggesting that future studies enrolling larger samples may be needed to further
disentangle possible placebo effects of needle insertion from the therapeutic
effectiveness of the NADA protocol.
Placing the current findings within a larger clinical context, the range
of effective treatments for cocaine addiction is at present quite limited;
thus, if findings from the current study are replicated, acupuncture could
be an important addition to current treatment options. Some psychosocial approaches
for the treatment of this disorder have been supported by clinical research,37 but no pharmacological agent has demonstrated efficacy
in controlled trials. Acupuncture is a treatment modality with a low side-effect
profile that does not exclude patients who have difficulty participating in
verbally mediated treatment interventions. Also, as in the Lincoln Hospital
setting in Bronx, NY, in which the NADA protocol was originally developed,38 it can be provided to large numbers of patients simultaneously,
making it a relatively low-cost treatment modality.2
Further research investigating cost-effectiveness and predictors of response
to acupuncture may be worthwhile.
This study had a number of limitations that should be considered in
interpreting our findings. First, the acupuncturist was not blinded with respect
to treatment assignment and patients were only partially blinded. Although
bias checks suggested that the treatments were equally credible and that therapeutic
alliance was comparable across conditions, this does not raise the rigor of
this study to the level of one conducted under double-blind conditions. However,
procedures, unlike pharmacotherapies, are nearly impossible to evaluate under
conditions in which both the patients and the practitioners are blinded. There
are several reasons for this. Training and competency are a prerequisite to
providing the treatments, and experienced practitioners will therefore know
which treatment is hypothesized to be active. In addition, whereas in a pharmacotherapy
study the active medication and the pill placebo can be made identical in
appearance, procedures are observably different to all of the participants
in the study. Hence, the present study had to be conducted under single-blind
conditions. However, several checks against potential bias (eg, observation
of the acupuncturist, assessment of therapeutic alliance) were included in
the design. Second, participants in this study were dually dependent on cocaine
and opiates, were maintained on a regimen of methadone, and had undergone
previous unsuccessful treatment attempts provided by their MMP. It is possible
that these patients may differ in their response to acupuncture from patients
not taking methadone or patients who may be responsive to psychosocial intervention.
Therefore, the extent to which our findings are generalizable to other settings
or subpopulations is not known. However, it could be argued that a positive
treatment response in this difficult-to-treat patient population supports
acupuncture's potential generalizability to other substance abuse treatment
settings. Finally, the relatively higher dropout rate in the NADA acupuncture
condition is unexplained and may have influenced outcome in ways that are
not apparent. However, there were no differences in any adverse effects of
treatment (eg, pain), and there were no interactions between treatment and
retention on any measured patient characteristic, such as severity of addiction
or motivation for abstinence, that might influence response to treatment.
Furthermore, retention in the NADA acupuncture protocol was also either better
than or comparable with that of other studies of pharmacological and psychological
treatments for cocaine dependence39, 40;
thus the relatively low retention rate in the NADA protocol does not weaken
its generalizability to other treatment settings.
Because unexplained differential treatment retention is an issue that
can potentially obfuscate interpretation of findings from randomized clinical
trials, methods for improving retention need to be considered in future studies.
Providing incentives to patients to remain in treatment is a strategy that
has been used to improve retention in controlled clinical trials; however,
this strategy is not without problems,41 having
the potential to alter the treatment being assessed or to produce motivational
conflicts.42 Various strategies may need to
be considered in future trials of acupuncture to address the problem of differential
treatment retention.
The present study also had several strengths. First, the NADA auricular
acupuncture protocol was compared with 2 conditions that controlled for multiple
nonspecific effects of acupuncture. Comparing a putative active treatment
with so-called active placebos constitutes a highly conservative test, one
that some pharmacotherapies that are generally regarded as effective have
not always passed.43 Second, the randomization
procedure was computer based with real-time assignment generated for each
patient, which concealed future treatment assignments. Third, the primary
outcome variable, cocaine use, was based on a laboratory test of urine screens
that were collected 3 times weekly, making it unlikely that instances of cocaine
use were missed or that patients could dissemble cocaine abstinence. Fourth,
attendance records indicated that, on average, patients in all 3 conditions
received a comparable "dose" of the treatments. Finally, evaluators were blinded
to patients' treatment assignment.
In conclusion, findings from the present study support the use of acupuncture
for the treatment of cocaine addiction. However, these findings should be
interpreted relative to the methodological difficulties inherent in evaluating
clinical procedures in controlled trials. Further research of acupuncture
in this application, including both clinical and foundational studies, appears
to be warranted.
Author/Article Information
From the Division of Substance Abuse, Department of Psychiatry (Drs
Avants, Margolin, and Kosten), and Division of Biostatistics, School of Epidemiology
and Public Health (Dr Holford), Yale University School of Medicine, and Department
of Psychiatry, Veterans Affairs Connecticut Healthcare Center (Dr Kosten),
New Haven.
Reprints: Arthur Margolin, PhD, Substance Abuse Center, Yale University
School of Medicine, 34 Park St, New Haven, CT 06519 (e-mail: arthur.margolin@yale.edu).
Accepted for publication February 28, 2000.
This study was supported by grants DA08513, DA00277, DA09241, and P50-DA09241
from the National Institutes on Drug Abuse, National Institutes of Health,
Bethesda, Md.
Acupuncture needles for this study were donated by Seirin Co Ltd, Shimizu-City,
Japan.
We thank Stephen Birch, PhD, for contributing his expertise and knowledge
regarding acupuncture practice and theory to this project.
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