Acupuncture for the Treatment of Cocaine Addiction

200 S. Kelly et al.TABLE 1Means (SDS) for Cocaine Use Variables for Treatment Completers (n = 30) at Baseline and Over the Courseof the B-Week Study by Type of Needle Puncture Treatment ReceivedStudy Week0 1 2 3 4 5 6Urine ToxicologyPercent Cocaine PositiveActive acupunctureControl needle punctureSelf-ReportGrams Used per WeekActive acupunctureControl needle punctureNumber of Days Used Per WeekActive acupunctureControl needle punctureCraving rating: (Scale: 0- 10)Active acupunctureControl needle puncture93.7 71.9 65.6(25.0) (40.7) (47.3)92.9 82.1 71.4(26.7) (31.7) (37.8)1.3(2.9)1.7(3.5)1.4 0.3(3.0) (0.4)1.1 0.9(1.4) (0.9)2.2 1.8 1.2(1 .a) (1 .a) (1.2)2.1 1.8 2.0(1.9) (1.8) (1.4)3.3 1.6 1.1(3.5) (2 3) (1.3)3.3 2.3 2.1(3.4) (2.4) (2.1)62.5 65.6 56.2 53.1(46.5) (43.7) (44.2) (46.4)67.9 71.4 67.9 57.1(46.4) (42.6) (42.1) (43.2)0.2(0.3)0.9(1.4)0.9(1 .O)1.5(1.5)0.7(1.4)2.0(2.1)0.2 0.6 0.2(0.3) (1.a (0.5)0.7 0.5 0.2(1 .O) (0.7) (0.3)0.6 1.0 0.6(0.6) (1 .O) (1 .O)1.4 1.1 0.6(1.7) (1 .O) (0.7)0.6 0.6 0.4(1 .O) (0.9) (0.9)2.0 1.8 2.7(2.4) (2.5) (2.7)Note. Mtssed urine = positive for cocalne metabolite; missed self-report = weekly mean for subject’s treatment groupBeck Depression Inventory. There was a main effectfor Time (F[ 1, 281 = 9.95, p < .004). Depression decreasedsignificantly across the 6-week study [PretreatmentM = 19.6 (+- 12.4); Posttreatment M = 14.1(+ 10.6)]. There was no main effect for type of acupuncture,and there was no significant interaction.ASI Composite Scores. There were main effects forTime for the following composite scores: Intensity ofDrug Problems (F[ 1, 281 = 7.40, p < .Ol ; pretreatmentM= .35 (k.13); posttreatment M= .29 (&.ll)), andIntensity of Legal Problems (F[ 1,281 = 6.20, p < .02;pretreatment M = .07 [*. 121; posttreatment M = .03[*.07]). There were no main effects for type of acupunctureand no significant interactions.SCL-90 Scores. There were main effects for Time forthe following subscale scores: Somatization (F[l, 281 =8.05, p < .008; pre M = 1.27 [+ .91]; post M = 0.92[+-.69]); Depression (F[l, 281 = 7.57, p < .Ol; preM=1.35[+.99];postM=1.01 [+.93]);Anxiety(F[1,28] =9.28, p < .005; pre M = 1.12 i-t.901; post A4 = 0.74f&77]); Phobic Anxiety (F[ 1,281 = 5.50, p < .03; preM = 0.76 [k .75]; post M = 0.53 [+ .68]); and Psychoticism(F[l, 281 = 6.03, p < .02; pre M= 0.81 [*.74];post M= 0.61 + .66]). There were no main effects fortype of acupuncture, and no significant interactions.Attitudes Toward and SubjectiveResponses to AcupunctureTreatment Credibility Scale. Means and standard deviationsfor scores on the TCS are shown in Table 2.A series of 2 (type of acupuncture) x 2 (pre/post 6-weektreatment period) mixed ANOVAs were conducted onthe five TCS items. Collapsed across type of acupuncture,confidence that acupuncture would help with druguse, and confidence in recommending acupuncture toa friend increased from pretreatment to post-dweektreatment (F[l, 281 = 5.03, p < .03, and F[l, 281 =14.55, p < .OOl, respectively). There was no significantchange in how logical the treatment seemed either fordrug use or for other health problems, or in subjects’confidence that the treatment would be useful for thetreatment of other health problems. There were nomain effects for type of acupuncture on any of the fiveitems and no significant interactions. Pearson correlationsrevealed no significant relation between confidencein acupuncture and percent of urines positive forcocaine submitted during the course of the study, eitherby type of needle puncture received, or collapsedacross needle puncture conditions.Acute Effects of Acupuncture (AEA) Scales. A seriesof 2 (type of acupuncture) x 2 (pre/post acupuncture

llAcupuncture for Cocaine Dependence 201TABLE 2Treatment Credibility Scale Means (+SD) Preacupuncture and Postacupuncture Treatment forTreatment Completers (n = 30)How confident are you that acupuncture canhelp you with your drug problem?*Active acupunctureControl needle punctureHow confident are you that acupuncture canhelp you with any health problems you have?Active acupunctureControl needle punctureHow confident are you in recommendingacupuncture to a friend with similar problems?*Active acupunctureControl needle punctureHow much sense does it make that acupuncturewould help you with your drug problem?Active acupunctureControl needle punctureHow much sense does it make that acupuncturewould help you with other health problems?Active acupunctureControl needle puncture-Pretreatment2.75 (k0.86)2.64 (kO.63)2.62 (k0.88)2.54 (kO.65)2.56 (kl.21)2.50 (kO.94)2.43 (kO.89)2.79 (kO.89)2.25 (kO.93)2.21 (t-0.97)Posttreatment3.31 (kO.79)3.00 (* 1.04)2.87 (kO.72)2.79 (k0.89)3.19 (kO.83)3.43 (kO.94)3.00 (kO.97)3.00 (kO.55)2.50 (+l .09)2.57 (kO.76)Note. Scale. 0 (not at all) to 4 (extremely).*Significant difference pre/post 6-week treatment collapsed across type of needle puncture. There wereno differences between the two types of needle puncture on these measures of treatment credibility.session) mixed ANOVAs were conducted on the eight There were several main effects for Time. CollapsedAEA items. The mean subjective responses to a sin- across type of needle insertion, nervousness and degleacupuncture session (active or control needle punc- pression decreased (F[ 1, 151 = 7.40, p < .02 and F[ 1,ture) during the first week of treatment are presented 151 = 11.12, p < .005, respectively), and relaxation,in Table 3. sleepiness, and lightheadedness increased (F[ 1, 151 =TABLE 3Acute Subjective Effects of a Single Acupuncture Session During the First Week of TreatmentActive (n = 7)Control (n = 10)Pre-SessionPost-SessionPre-SessionPost-SessionNervous *DepressedRelaxed lHappySleepy lEnergeticBody feels heavyLightheadedPain:Upon insertion/earsUpon insertion/handsDuring session1.29 (1.11)1 .71 (1 .25)1 .14 (0.69)1 .42 (0.79)0.71 (0.76)1.42 (0.53)0.71 (0.95)0.43 (0.79)-0.29 (0.76)0.71 (0.76)3.00 (1.15)1 .86 (0.69)1.71 (0.76)0.86 (0.69)1 .OO (0.82)1.00 (1.00)0 50 (0.76)0.29 (0.76)0.25 (0.46)0.60 (0.97)1.10 (1.20)1.80 (1.40)1.40 (0.84)0.80 (1.03)0.30 (0.48)1.10 (1.20)0.50 (0.71)-0.30 (0.48)0.60 (0.70)2.60 (0.97)1.60 (0.70)1.60 (1.35)1.20 (0.92)0.70 (1.06)1.20 (0.42)0.45 (0.69)0.20 (0.42)0.18 (0.40)Note. Scale 0 (not at all) to 4 (extremely).‘Significant changes preipost session collapsed across type of needle puncture. There were no significantdifferences between the two types of needle puncture on any measured acute effect of a singleacupuncture session.

202 S. Kelly et al.21.32, p < .OOl; F[l, 151 = 17.25, p < .OOl; and F[l,151 = 7.23, p < .02, respectively). There was no changepre/post session in feelings of happiness, energy, orheaviness. There were no main effects for type of acupunctureand no significant interactions. Comparingposttreatment pain ratings for active and control needlepuncture, t tests revealed no significant differencesin pain ratings between the two types of needle punctureconditions; as shown in Table 3 intensity of paineither upon insertion of needles or during the courseof the session was minimal for either type of needleinsertion.Exploratory Analyses by HIV StatusHIV Status. There was good treatment retentionamong both HIV-negative and HIV-positive patients;77.8% (14/18) of HIV-positive patients and 72.7%(16/22) of HIV-negative patients completed the 6-weekstudy. There was a trend for HIV-positive patients whocompleted treatment to provide fewer cocaine-positiveurines during the course of the study (Mean = 54.2% of:34.6) than HIV-negative patients (Mean = 76.0% k30.1) (F[ 1,281 = 3.44, p < .07). In addition, 50% ofHIV-positive patients (compared to 25% of HIVnegativepatients) were able to initiate abstinence bystudy completion.DISCUSSIONWe conducted a propaedeutic trial in order to investigateseveral issues critical to the design of a large-scalestudy of acupuncture for the treatment of cocaine addictionin methadone-maintained patients. Results,overall, showed a significant decrease in cocaine usefrom baseline, with good treatment retention. In addition,significant improvements were seen on a numberof psychosocial measures (i.e., Beck depression,AS1 drug severity, and several SCL-90 subscales). Wefound no statistically significant difference between theactive and control needle puncture treatments on anymeasure, with the exception of craving; the active acupuncturegroup reported significantly less craving forcocaine during the course of the study than did thecontrol needle puncture group.Appropriateness of the Needle PunctureControl ConditionPower calculations were conducted to determine thesample size necessary to detect the difference betweenneedle puncture groups for percentage of urines testingpositive for cocaine during the course of the study(active: 69.17% [+35.67]; control: 78.33% [&28.54]).We calculated that with power at .80 and alpha at .05,196 subjects per treatment group would have been necessaryto detect this relatively small effect size of .28.This is a considerably larger sample than is suggestedby either Lewith and Machin’s (1983) or Pomeranz’(1987) power calculations for detecting differences between“real” and “sham” acupuncture. Assuming thatsubjects in the active acupuncture group did, in fact,receive an optimally active treatment, several findingsfrom the current study suggest that the control needlepuncture procedure we used might have been a relatively“active” treatment. These include the small treatmenteffect size, lack of significant differences in thesubjective ratings between the two groups after an acupuncturesession, as well as between the groups on theirratings of confidence in acupuncture either pretreatmentor posttreatment - both increased. Other researchersusing a needle puncture control conditionsimilar to that employed in this study-insertion ofneedles into theoretically “inactive” points close to activesites-have also reported overall reductions in illicitdrug use, but no significant differences betweentreatment groups (Jackson, Wells, Diaz, Staton, &Saxon, 1994). Lipton et al. (1994) employed pointsused for treating skeletomuscular disorders, which arewithin 5 mm of active points and which are not indicatedfor the treatment of addiction, as control points.They, too, speculate that these control points may havebeen too “active.”Our study does not, of course, demonstrate that thecontrol sites we employed were entirely inappropriate;in fact, means on all drug outcome measures were inthe direction of an effect for the active needle puncturecondition. It is also possible that an undocumented,idiosyncratic aspect of our acupuncturist’stechnique may have influenced results. However, inview of the considerable investment of resourcesneeded to conduct clinical trials, we think that siteswith less apparent activity should be chosen as controlsin future studies. A promising strategy might beto locate auricular control points entirely outside ofthe regions of active points. For drug addiction studiesthis would mean that control points should not belocated within the ear concha. We have begun to investigatethe ear helix as a possible location for auricularcontrol points, in particular, sites on the helix thatare not hypothesized to be active treatments for addictionin any system of acupuncture. We are conductinga single-blind study in which patients provideratings after needle insertion into helix points, activesites, and two “control” configurations-the controlused in the present study, and the control used by Liptonet al. (1994).-Preliminary findings suggest thatthe helix points are perceived by patients as the leastactive (Margolin, Avants, Chang, Birch, & Kosten, inpress).

204 S. Kelly et al.cha and the helix. The need to isolate patients in orderto maintain the blind may conflict with the creationof a setting in which patients can observe each otherduring treatment. The proper resolution of these twoconditions would need to be worked-out before embarkingon a full-scale study, for example, by segregatingpatients by group by treatment assignment.5. Experience of Study Acupuncturists. Experience inthis study reinforced our opinion that acupuncturestudies with needle puncture controls place special demandson study acupuncturists and, therefore, requirepractitioners who possess technique of the highest caliberwho are able to work within the strictures of a researchprotocol. Acupuncture in research studiesshould be delivered only by acupuncturists who havehad extensive experience in full-body and auricularacupuncture and who have had considerable practicehoning the control procedure.We would like to briefly discuss an alternative interpretationof our data. Our findings could be interpretedas patients’ response to a novel, somewhat invasive,procedure in both groups-that is, to the administrationof an active placebo. Furthermore, it is possiblethat the overall improvements found in drug use andpsychosocial functioning were due to nonspecific factorssuch as daily staff attention, increased staff andpatient monitoring of drug use, or to a relaxing effectof reclining for an hour in a quiet room each day.The addition of a relaxation control group in futurestudies would allow for an assessment of some of thenonspecific effects of acupuncture treatments upontreatment outcome. However, given the present stateof our knowledge concerning acupuncture, there is noobvious way to definitively resolve issues concerningthe effect of placebo response on treatment outcome.In order for this to be accomplished, the needle puncturecontrol condition would have to be shown to beinert, a priori and independently of patient response,like a pill placebo in pharmacotherapy studies. Acupunctureresearch methodology is not sufficiently advancedto conduct “conclusive” studies. In our opinion,findings from the current study, such as overall improvementin outcome measures related to addiction,good treatment retention, relatively favorable abstinencerates in the 6th week of the study, and the overallresponse of HIV positive patients to acupuncture,suggest that further investigations of this treatmentmodality are warranted. 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