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Margolin A, Kleber HD, Avants SK, et al. Acupuncture for the Treatment of Cocaine Addiction: A Randomized Controlled Trial. JAMA. 2002;287(1):55–63. doi:10.1001/jama.287.1.55
Author Affiliations: Yale University School of Medicine, New Haven, Conn (Drs Margolin and Avants); National Center on Addiction and Substance Abuse, Columbia University, New York, NY (Drs Kleber, Boles, and Vaughan); Columbia University School of Medicine, New York, NY (Drs Kleber and Vaughan); University of Miami School of Medicine, Miami, Fla (Dr Konefal); UCLA Laboratory for the Study of Addiction, Los Angeles, Calif (Drs Gawin and Stark); University of California, San Francisco, and San Francisco General Hospital (Drs Sorensen and Midkiff); Evergreen Treatment Services, Seattle, Wash (Dr Wells and Mr Jackson); and Hennepin County Medical Center, Minneapolis, Minn (Dr Bullock and Ms Culliton).
Context Auricular acupuncture is widely used to treat cocaine addiction in the
United States and Europe. However, evidence from controlled studies regarding
this treatment's effectiveness has been inconsistent.
Objective To investigate the effectiveness of auricular acupuncture as a treatment
for cocaine addiction.
Design Randomized, controlled, single-blind clinical trial conducted from November
1996 to April 1999.
Setting Six community-based clinics in the United States: 3 hospital-affiliated
clinics and 3 methadone maintenance programs.
Patients Six hundred twenty cocaine-dependent adult patients (mean age, 38.8
years; 69.2% men); 412 used cocaine only and 208 used both opiates and cocaine
and were receiving methadone maintenance.
Intervention Patients were randomly assigned to receive auricular acupuncture (n
= 222), a needle-insertion control condition (n = 203), or a relaxation control
condition (n = 195). Treatments were offered 5 times weekly for 8 weeks. Concurrent
drug counseling was also offered to patients in all conditions.
Main Outcome Measures Cocaine use during treatment and at the 3- and 6-month postrandomization
follow-up based on urine toxicology screens; retention in treatment.
Results Intent-to-treat analysis of urine samples showed a significant overall
reduction in cocaine use (odds ratio, 1.40; 95% confidence interval, 1.11-1.74; P = .002) but no differences by treatment condition (P = .90 for acupuncture vs both control conditions). There
were also no differences between the conditions in treatment retention (44%-46%
for the full 8 weeks). Counseling sessions in all 3 conditions were poorly
Conclusions Within the clinical context of this study, acupuncture was not more
effective than a needle insertion or relaxation control in reducing cocaine
use. Our study does not support the use of acupuncture as a stand-alone treatment
for cocaine addiction or in contexts in which patients receive only minimal
concurrent psychosocial treatment. Research will be needed to examine acupuncture's
contribution to addiction treatment when provided in an ancillary role.
Cocaine addiction continues to be a serious problem in the United States.
The Office of National Drug Control Policy estimates that in 1998 there were
3.3 million chronic cocaine users.1 Although
several psychological and behavioral approaches have shown promise,2,3 treatment for cocaine addiction has
been impeded by the lack of a generally effective pharmacologic agent. Partly
because of this lack, auricular acupuncture as codified by the National Acupuncture
Detoxification Association (NADA)4 is now one
of the most widely used treatments for this disorder, with more than 400 substance
abuse clinics in the United States and Europe providing this form of treatment.5 Auricular acupuncture is also a treatment component
in numerous drug court programs.
The mechanism by which acupuncture may treat cocaine addiction is unclear.
Clinical reports suggest that it has a calming effect upon patients, decreases
craving for cocaine, and promotes retention of patients in psychosocial treatments.6 Research on acupuncture for the treatment of cocaine
addiction has shown mixed results: some studies have found no difference between
the NADA protocol and needle-insertion control,7-10
while others have reported promising findings.11-14
The methods used in these studies have varied, further impeding inferences
concerning efficacy. Given the widespread use of auricular acupuncture in
treating cocaine addiction, a multisite study enrolling individuals who were
dependent on cocaine only (primary cocaine users) and on opiates and cocaine
and who were receiving methadone maintenance (methadone-maintained) was warranted.
We conducted the study from November 1996 until April 1999.
To control for various aspects of the acupuncture treatment context
that might influence outcome, we used 2 active control conditions—insertion
of needles into non–NADA-specified points and a relaxation condition.
Because the investigation of acupuncture is difficult if not impossible to
conduct under double-blind conditions, this study was conducted single-blind.15 In addition, because all of the treatments tested
are to some degree active, the study was described to patients as an investigation
of various alternative therapies for cocaine addiction, specifically, relaxation
and 2 types of acupuncture.
The primary hypotheses of the study were as follows: compared with those
in the 2 control conditions, patients assigned to the NADA treatment condition
would be more likely to provide negative urine screens throughout the course
of the study and at follow-up and more likely to complete treatment and be
retained in treatment longer.
Participants were recruited from 6 sites: 412 from the primary sites
(Los Angeles, Calif: n = 148; Miami, Fla: n = 159; San Francisco, Calif: n
= 105) and 208 from the methadone-maintained sites (New Haven, Conn: n = 83;
Minneapolis, Minn: n = 50; Seattle, Wash: n = 75). The intent-to-treat (ITT)
sample comprised the 620 patients who were randomized to treatment. This sample
size provided sufficient power (>.80; α = .05) to detect a small treatment-effect
size (.20) among the treatment conditions on the percentage of urine screens
testing positive for cocaine throughout the course of the study, allowing
for an overall dropout rate of between 50% (power = .90) and 60% (power =
.82), typical of addiction studies.16 The research
protocol was approved by the investigational review boards of each site, and
all participants provided written informed consent to participate in the study.
To be included in the study, participants had to be at least 18 years
of age, have been diagnosed with cocaine dependence according to the Structured
Clinical Interview for the Diagnostic and Statistical Manual
of Mental Disorders, Fourth Edition (SCID),17 and have evidence of recent cocaine use either by
providing a cocaine-positive urine screen at or within 2 weeks before screening
or by self-reporting cocaine use in the week before screening. Exclusion criteria
were as follows: (1) being dependent on any substance besides opiates, cocaine,
or nicotine; (2) currently receiving treatment for cocaine dependence; (3)
currently taking a prescription benzodiazepine; (4) currently taking any other
psychotropic medication unless maintained on this medication for at least
90 days; (5) currently receiving acupuncture treatment or having had acupuncture
in the previous 30 days; and (6) being actively suicidal or psychotic. Patients
who failed to attend 3 of the first 8 sessions or failed to attend at least
1 session weekly thereafter were discontinued from treatment and coded as
Following completion of the screening and intake interviews, patients
were randomized to 1 of the 3 treatment conditions according to a permuted-block,
computer-based randomization procedure that balanced each site's sample by
sex. Patients were told their treatment assignment and attendance requirements.
Treatments were described with a standardized script, encouraging patients
to view all of the study treatments as ways to reduce stress, with potential
benefits for reducing craving and subsequent cocaine use. Patients assigned
to relaxation were also provided with instruction concerning the relaxation
protocol. Patients' progress through the trial is illustrated in Figure 1.
The treatments have been described in detail elsewhere.11
A brief description of each treatment follows.
Needles were inserted into the auricles bilaterally at 4 points in or
near the concha, which are commonly used in addiction treatment: "sympathetic,"
"lung," "liver," and "shen men." The single-use stainless
steel needles (Seirin Co Ltd, Shimizu-City, Japan) were 0.2 mm wide and 15.0
mm long. There were several reasons why we used a 4-needle version of the
NADA protocol instead of the 5-needle version that is more widely used in
clinical practice. First, we wanted to avoid overstimulating the auricle in
the control condition because of controversies concerning whether effects
are due to stimulation of specific points or the auricle overall.18 Second, there is a well-established tradition of
using fewer than 5 needles in controlled studies of auricular acupuncture
in the addictions.7,8,11,14,19
Third, studies using fewer than 5 needles have reported effectiveness compared
with needle-insertion controls, supporting the validity of the 4-needle protocol.7,11,14,19 Fourth,
there is latitude in the number of needles inserted—the NADA training
manual states that the NADA protocol involves the insertion of from "3 to
5 needles into the auricle."20
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 regions
not commonly used for addiction treatment.21
Patients viewed commercially available videos depicting various relaxation
strategies and containing relaxing visual imagery (eg, nature scenes) and
Treatments in the 3 conditions were provided for 40 minutes each weekday
for 8 weeks. Patients were encouraged to attend treatment daily. Financial
incentives were provided for attendance. Patients received $2 after each treatment
session and an additional $10 at the end of each week in which at least 2
treatments had been received and 3 urine samples provided. Treatments in all
3 conditions were administered by licensed acupuncturists certified to provide
the NADA protocol. The acupuncturists were not permitted to converse with
patients. Patients assigned to different treatment conditions were not treated
At the primary cocaine sites, patients were offered weekly individual
counseling sessions according to a treatment manual that was developed for
this study and focused on changing addictive behaviors.22
Patients were not discharged from the study for nonattendance. Methadone-maintained
patients continued to receive standard methadone maintenance, which included
All assessments were conducted by research staff blind to patients'
The research protocol called for the collection of urine samples 3 times
weekly, Monday, Wednesday, and Friday. Missed Monday or Wednesday samples
were collected, if possible, the following day. Urine samples were collected
from noncompleters at the follow-up points but not during the 8-week treatment
phase after dropout. The Abbott TDx method (Abbott Laboratories, Abbott Park,
Ill) was used to test samples for the presence of cocaine metabolite (benzoylecgonine).23 Samples containing at least 300 ng/mL were considered
positive for cocaine.
Amount (number of so-called dime bags) and frequency (number of days)
of cocaine use and craving for cocaine (scale, 0-10) were assessed in weekly
The Addiction Severity Index (ASI)24
was administered at entry into the trial, at the end of the 8-week treatment
phase, and at the 6-month follow-up. The ASI is a structured interview that
provides composite scores assessing the severity of 7 addiction-related problem
areas: alcohol, drug, employment, family, legal, medical, and psychiatric.
The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES,
Version 8D)25 was administered before and after
treatment. The scale is a 19-item questionnaire assessing readiness for treatment.
Patients are asked to circle numbers on scales from 1 (strongly disagree)
to 5 (strongly agree). The readiness composite score ranged from 11 to 71.
The Treatment Services Review (TSR)26
was administered weekly to monitor treatment services received by patients
during the study. The following variables were created by using attendance
records and TSR data: total acupuncture sessions, total relaxation sessions,
total on-site drug counseling sessions, and total off-site Alcoholics Anonymous,
Narcotics Anonymous, and Cocaine Anonymous meetings.
The Treatment Credibility Scale (TCS)27
is a 5-item questionnaire that was administered before and after treatment
to assess perceived credibility of the treatment to which the patient was
assigned. The scale ranges from 1 (not at all) to 6 (very confident); items
were averaged to provide a single treatment credibility score, with high scores
reflecting high treatment credibility.
Patient alliance with the acupuncturist–relaxation trainer was
assessed with a modified therapeutic alliance scale28
administered at the end of the first treatment session and again in weeks
4 and 8. The 10 items were rated on 7-point scales from 1 (never) to 7 (always)
and summed (α = .94). Higher scores reflected greater therapeutic alliance
Acute response to treatment sessions was assessed weekly on 5-point
scales from 0 (not at all) to 4 (extreme). The following domains were included:
(1) pain and de qi–associated sensations (ie,
pain in the ears when the needle was inserted, pain at needle sites during
the session, warmth in the ears, activity in the ears, and radiating sensations
from the ears to the face, neck, or shoulders), (2) relaxation effects relative
to presession levels (eg, relaxation, heaviness, warmth, sleepiness, and looser
muscles), and (3) 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). Participants were also
asked how much they would be willing to pay for such a treatment session in
the future ($0, $5, $10, $15, or $20). The day after treatment, as a measure
of the duration of treatment effects, participants were asked how long the
previous session's effects lasted (0 = no effect, 1 = less than 1 hour, 2
= 2-3 hours, 3 = all afternoon, and 4 = all night). Items in each category
The 3 conditions were compared on time to dropout with the Kaplan-Meier
method and the log-rank test. Examination of 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 accomplished with a series of 3 (treatment condition) × 2 (retention
status) analyses of variance on continuous variables and χ2
analyses by treatment condition and retention status for categorical variables.
The primary outcome analysis, cocaine use based on the thrice-weekly
urine samples, was conducted on the ITT sample. SAS PROC GENMOD (SAS Institute
Inc, Cary, NC; Version 6.12) was used for the analysis, with each sample coded
as positive (1) or negative (0). These data were analyzed by using generalized
estimating equations (GEEs) and the z test, as described by Liang and Zeger,29 with the specification of a logit link function,
binomial error, and exchangeable working correlation structure. The GEE approach
was used for the primary analysis because it is expressly designed to handle
repeated measures, intracorrelated binary data with varying numbers at each
time point. Secondary analyses included analysis of urine data provided by
the subsample of patients who completed the 8-week treatment phase of the
study (completers). To determine differential abstinence status at the completion
of treatment, χ2 analyses were conducted by treatment condition
on rates of completers whose urine samples were cocaine-negative in week 8.
Changes in the ASI severity of addiction composite scores and the SOCRATES
readiness for treatment score were also assessed with a series of repeated-measures
analyses of variance.
The ITT sample provided an average of 2.38 (SD, 0.80) urine samples
weekly while participants were in treatment. The treatment completers provided
an average of 2.53 (SD, 0.49) urine samples weekly. At the 3-month follow-up,
a urine sample was provided by 80.3% (224/279) of the completers and 26.1%
(89/341) of the dropouts. At the 6-month follow-up, a urine sample was provided
by 74.5% (208/279) of the completers and 29.3% (100/341) of the dropouts.
For pretreatment ASI severity of drug problems (t609 = 0.038, P = .97), there was no significant
difference between patients who did and did not provide a follow-up urine
screen. Posttreatment ASI data were provided by 94.3% (263/279) of the completers
and 41.6% (142/341) of the dropouts; 6-month ASI data were provided by 82.4%
(230/279) of the completers and 33.7% (115/341) of the dropouts.
The mean age of the ITT sample was 38.80 (SD, 7.60) years. There were
429 (69.2%) men and 190 (30.6%) women, and there was 1 (0.2%) transgendered
person. The sample included 179 (28.9%) whites; 372 (60.2%) blacks; 45 (7.3%)
Hispanics; and 22 (3.6%) who identified themselves as "other" minority. Seventy-four
(11.9%) had not graduated from high school and 468 (75.5%) were not employed
full-time. Patients had used cocaine for an average of 10.94 (SD, 7.10) years.
There were no significant differences among the sites or treatment conditions
on any pretreatment demographic variable. Table 1 provides demographic data by treatment condition.
Attendance at assigned treatment did not differ significantly across
treatment conditions. For the ITT sample, the mean (SD) number of treatment
sessions attended was as follows: auricular acupuncture, 15.44 (10.48), needle-insertion
control condition, 15.73 (9.54), and relaxation control condition, 14.53 (9.42).
For the completed sample, the number of sessions attended was as follows:
auricular acupuncture, 23.38 (7.08), needle-insertion control condition, 21.73
(7.15), and relaxation control condition, 20.70 (6.73). Receipt of assigned
treatment was generally equivalent across conditions.
Overall, attendance at psychosocial treatment sessions was poor. Less
than 20% of patients reported having an interaction with a counselor each
week of the study. More than 50% reported attending less than 1 counseling
session each month. Attendance at Alcoholics Anonymous, Narcotics Anonymous,
and Cocaine Anonymous meetings was also poor across conditions. Thirty-eight
percent of the patients attended no self-help meetings at all while in the
study; less than 20% attended such meetings weekly. There were no significant
differences by treatment condition on receipt of adjunctive psychosocial services
There was no significant difference by treatment condition on either
treatment credibility (F24,90 = 0.749, P
= .47) or therapeutic alliance (F24,97 = 1.434, P = .24). Patients in each condition found the treatments to be credible
and reported a positive therapeutic alliance with the treatment provider.
Relaxation-control patients reported significantly more relaxation effects
following their treatment session than did either needle-insertion control
patients (P = .001) or those assigned to acupuncture
(P<.001; F25,45 = 27.104, P<.001). There were no significant differences between the 3 treatment
conditions on ratings of satisfaction with sessions, duration of treatment
effects, or willingness to pay for future sessions. Comparisons between the
2 needle-insertion conditions revealed no significant differences on ratings
of pain or de qi sensations. Table 2 presents mean scores of measures designed to check the integrity
of the treatment conditions for the ITT sample.
Of the 620 patients who were randomly assigned to treatment conditions,
279 (45%) were retained for the full 8-week trial. Methadone-maintained cocaine
users were significantly more likely to complete treatment (63%) than were
primary cocaine users (36%; χ21= 40.888, P = .001). However, there was no significant difference in the completion
rate by treatment condition collapsed across sites: auricular acupuncture,
100 out of 222 patients (45.0%); needle-insertion control condition, 93 out
of 203 patients (45.8%); relaxation control condition, 86 out of 195 patients
(44.1%). There was no significant difference in the mean (SD) number of weeks
patients were retained in treatment: auricular acupuncture, 4.87 (3.19); needle-insertion
control condition, 4.84 (3.28); relaxation control condition, 4.70 (3.28)
(log-rank(1) = 0.13, P = .72). Table 3 provides completion rates by treatment condition and site.
There were no significant differences on any pretreatment variable by
treatment condition. However, there were differences by retention status.
Patients who completed treatment were significantly older (dropped mean [SD]:
38 [7.6]; retained: 40 [7.5] years; t618
= 3.58, P<.001), less likely to be employed full-time (dropped: 15.1%; retained: 8.1%; χ21 = 5.784, P = .01), more severely
addicted as measured by the ASI drug problems composite score (dropped mean
[SD]: 0.23 [0.09]; retained: 0.24 [0.10]; t609 = 1.984, P = .048), more likely to use
cocaine intravenously (59%) or intranasally (54%) than by smoking (41%; χ22 = 11.91, P = .003), and less
motivated for treatment as measured by the SOCRATES (dropped mean [SD]: 48.29
[9.20]; retained: 46.32 [8.13]; t605 =
2.768, P = .006). There was no significant interaction
between type of cocaine abuser (methadone or primary) and treatment retention
on any of these variables.
As a condition for entry, all patients had to have used cocaine within
2 weeks of screening; thus, there were no pretreatment differences among the
treatment conditions on cocaine use before entry into treatment. Table 4 presents percentage of cocaine
urine screens testing positive for cocaine metabolite by treatment condition
and site during the 8-week treatment phase. Overall, methadone-maintained
patients provided a significantly higher percentage of cocaine-positive urine
screens (74.9% [30.4%]) compared with primary cocaine users (67.1% [38.0%];
F15,50 = 5.309, P = .02). There were no
other differences between these 2 patient groups. Because there were no treatment
× site or treatment × patient-group interactions, all subsequent
outcome analyses are presented collapsed across site and patient group.
As a primary test of treatment effectiveness, GEE was conducted on the
urine samples by comparing acupuncture to each of the control conditions in
separate analyses, with and without follow-ups, on both the ITT sample and
treatment completers. Because these analyses revealed no significant differences
between acupuncture and either of the control conditions, we present an overall
analysis comparing acupuncture with both control conditions, including the
2 follow-ups. This analysis revealed that collapsed across groups, there was
a significant decline in cocaine-positive urine samples (z = − 3.0, P = .002), with an overall odds ratio for a negative cocaine
urine screen of 1.40 (95% confidence interval, 1.11-1.74). However, the difference
between acupuncture and the 2 control conditions was not significant (z =
0.005, P = .90). Figure 2 presents urine toxicology results for the ITT sample by
treatment condition during the course of the 8-week trial and at the 2 follow-up
For the patients who completed the study, we performed an analysis on
the percentage of urine samples testing positive during treatment. This test
also revealed no significant differences by treatment condition (auricular
acupuncture mean [SD], 69.65% [32.80%], needle-insertion control condition,
65.61% [35.73%], and relaxation control condition, 65.23% [36.93%]; F22,76 = 0.466, P = .63). There were no significant
correlations between the number of treatment sessions attended and the percentage
of urine screens positive for cocaine, either overall (r  = 0.008, P = .90) or by treatment group
(auricular acupuncture: r  = −0.02, P = .90; needle-insertion control condition:
r  = 0.10, P = .35; and relaxation control
condition: r  = −0.09, P = .43).
These analyses were repeated controlling for race and sex and again
yielded no significant differences by treatment condition. Similar analyses
on self-reported amount, frequency of use, and craving for cocaine also yielded
no significant differences by treatment condition. Collapsed across treatment
conditions, the frequency of cocaine use decreased significantly from a mean
(SD) of 14.46 (9.48) days during the month before participants entered the
study to 6.43 (9.08) days during the month before the 6-month follow-up (F12,83 = 167.77, P = .001).
There were no significant differences among the conditions on the percentage
of patients not using cocaine by treatment completion or by either of the
2 follow-ups. Rates of abstinence during the final week of treatment by treatment
condition were as follows: auricular acupuncture, 23.4% (22/94), needle-insertion
control condition, 31.0% (27/87), and relaxation control condition, 28.8%
(21/73; χ22 = 1.393, P
= .50). Abstinence rates at the 3-month follow-up were as follows: auricular
acupuncture, 39.5% (45/114), needle-insertion control condition, 39.6% (40/101),
and relaxation control condition, 29.6% (29/98; χ22
= 2.874, P = .24). Abstinence rates at the 6-month
follow-up were as follows: auricular acupuncture, 43.7% (52/119), needle-insertion
control condition, 46.9% (45/96), and relaxation control condition, 35.5%
(33/93; χ22 = 2.689, P
There were main effects for time for severity of drug problems (F13,93 = 200.105, P = .001), psychiatric severity
(F13,94 = 20.098, P<.001), legal problems
(F14,00 = 22.006, P = .001), family problems
(F13,94 = 17.275, P<.001), and alcohol
problems (F13,98 = 15.606, P = .001).
Severity of drug, psychiatric, legal, family, and alcohol problems decreased
significantly from pretreatment to posttreatment, with improvements maintained
at follow-up. No significant improvements were found in medical or employment
problems or in readiness for treatment. No significant treatment condition
× time interactions were found on any addiction severity measure.
This study did not confirm our initial hypotheses. There were no differences
by treatment condition in cocaine use assessed by urine samples or self-report.
Throughout the study, there were modest reductions in cocaine use by patients
in all 3 conditions. Secondary analyses revealed no significant differences
among the treatments on any outcome measure. Relative to patients in the 2
control conditions, patients receiving NADA acupuncture were not retained
in treatment longer. Overall rates of cocaine use were comparable to those
in the first 8 weeks of studies of pharmacotherapies in methadone-maintained
subpopulations,30 as well as psychotherapies
in primary cocaine-addicted subpopulations.2
In the addictions, precise comparison with previous acupuncture studies is
impeded by varying treatment periods, ancillary counseling conditions, and
outcome measures. However, our results are consistent with findings from a
large-scale controlled clinical trial8 of acupuncture
for cocaine addiction in residential and day treatment settings, which also
found no difference between the NADA protocol and concurrent controls.
This multisite study was expressly designed to optimize methodologic
rigor31,32 and included several
design features that strengthened its internal validity: (1) objective assessment
of the primary outcome variable, cocaine use; (2) the use of 2 active control
conditions; (3) checks on treatment credibility; (4) assessment of patient-treater
alliance; (5) provision of treatments by certified NADA-trained acupuncturists;
(6) sufficient statistical power to detect a small difference in outcome among
the 3 conditions; and (7) pretreatment and posttreatment assessment conducted
by blind raters. We found no patient bias in favor of any of the treatments—treatment
credibility was equivalent among conditions, as was patient alliance with
the treatment provider. Attendance records indicated that, on average, patients
in all 3 conditions received comparable treatment. Across conditions, and
regardless of dropout status, patients received a clinically appropriate amount
of treatment, averaging between 2 and 3 treatments weekly.
We must also note several limitations in this study. Systematic controlled
research on a widely used procedural treatment, particularly one whose origins
reside outside of a Western biomedical framework, often requires a number
of standardizations and alterations that may result in deviations from clinical
practice. Our study included the following: use of a 4-needle treatment, while
the standard NADA treatment typically involves 5; treatment of research patients
in small groups or possibly alone, whereas in NADA clinics patients are more
often treated in larger groups; and nonintegration of the study treatments
within a comprehensive treatment program, as is recommended in the NADA literature.
In designing this study, we regarded these changes as constituting a reasonable
compromise among a number of concerns: the need for standardization of the
treatment conditions, the need for gaining an estimate of the effectiveness
of acupuncture treatments before undertaking more complex investigations examining
the interaction between acupuncture and a variety of psychosocial treatments,
and given that, as far as we are aware, no study comparing the 5-needle NADA
protocol with a 5-needle control has found a difference between the 2 protocols,
the need to adequately differentiate the experimental and control needle-insertion
conditions while still maintaining the integrity of the experimental treatment.
We recognize that any of the alterations noted above could have diminished
the internal and external validity of the study. Each betokens an important
area of research whose findings would strengthen the design of clinical trials
of acupuncture and would close the gap between research and clinical practice
in this area.
Our study used a research design nearly equivalent to that of a previous,
smaller study conducted at the Yale site11
in which the same 4-needle version of the NADA protocol delivered for 8 weeks
was found to be superior to the 2 control conditions in reducing cocaine use
in cocaine-dependent, methadone-maintained patients. In that study, 54% of
NADA acupuncture completers provided cocaine-negative urine samples in the
last week of the study compared with 23% of acupuncture completers in this
study. Patients in the 2 studies assigned to the NADA protocol received approximately
the same amount of treatment: 3.5 and 3.0 treatments weekly in the former
and current study, respectively. This result raises the question of how to
interpret the Yale findings relative to those of this study, including lack
of replication at the Yale site. The findings from these 2 studies alone do
not yield a definitive answer. Their design was similar, but there were some
differences that may have influenced outcome.33
In our study, standard care included drug counseling as delivered by the methadone
program. In the Yale study, standard care also included individual counseling
and a once-weekly group therapy session. Another difference is that our study
included monetary incentives in the form of cash payments for attendance.
Rewarding attendance, rather than abstinence, may have fostered retention
of more severely addicted, unmotivated patients, which may have biased findings.
Differences in treatment context may have contributed to divergent outcomes
between the 2 studies, but it is also possible that our larger study simply
provided a better estimate of acupuncture's "true" treatment effect compared
with that of the 2 control conditions.
In conclusion, within the clinical context of this study, we did not
find acupuncture more effective than a needle insertion or relaxation control
in reducing cocaine use. Our study therefore does not support the use of acupuncture
as a stand-alone treatment for cocaine addiction or when patients receive
only minimal concurrent psychosocial treatments. Research will be needed to
examine the contribution of acupuncture when provided in an ancillary role.