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Journal of Substance Abuse Treatment 26 (2004) 95 – 102 Regular article Treating drug using prison inmates with auricular acupuncture: A randomized controlled trial Anne H. Berman, M.Sc. a,b,*, Ulf Lundberg, Ph.D. a,b, Aud L. Krook, M.D., Ph.D. c, Carl Gyllenhammar, M.D. d b a Department of Psychology, Stockholm University, Frescati Hagväg 14, plan 3, S-106 91 Stockholm, Sweden Center for Health Equity Studies (CHESS), Stockholm University/Karolinska Institutet, Sveavägen 160, plan 5, S-106 91 Stockholm, Sweden c Center for Medication Assisted Rehabilitation (MARIO), Kirkeveien 166, N-0407 Oslo, Norway d Marums backe, S-184 97 Ljusterö, Sweden Received 28 March 2003; received in revised form 1 October 2003; accepted 3 October 2003 Abstract This study tested the viability of auricular acupuncture in prisons for alleviating inmates’ symptoms of psychological and physical discomfort and reducing their drug use. The experimental NADA-Acudetox protocol was compared with a non-specific helix control protocol in a randomized trial. Over a period of 18 months, a 4-week, 14-session auricular acupuncture treatment program was offered in two prisons to 163 men and women with self-reported drug use. Among treatment completers, no differences by method were found in self-reported symptoms of discomfort. Drug use occurred in the NADA group but not in the helix group. In contrast, confidence in the NADA treatment increased over time while it decreased for the helix treatment. No significant negative side effects were observed for either method. Participants in both groups reported reduced symptoms of discomfort and improved nighttime sleep. Future research should compare auricular acupuncture to a non-invasive control in order to attempt to disentangle active effects from placebo. D 2004 Elsevier Inc. All rights reserved. Keywords: Drug abuse treatment; Prisons; Auricular acupuncture; Discomfort; Side effects 1. Introduction Drug use among prison inmates is generally conceded among prison authorities in European countries (European Monitoring Centre for Drugs and Drug Addiction, 2002). About 60% of Swedish prison inmates are judged to be regular users of alcohol or illicit drugs (Krantz, Hagman, & Lindsten, 2002). Treatment of drug dependence can be approached by psychosocial treatment or by a combination of pharmacological and psychosocial treatment (Gerstein, 1999; Kreek, LaForge, & Butelman, 2002; National Institute on Drug Abuse, 2000). However, not all prison inmates who use drugs have access to such treatment or are motivated for it. Auricular acupuncture is a non-verbal, non-confrontational treatment method that can be administered by nonmedical staff to inmates who use different types of drugs and who do not need to clearly indicate motivation for drug treatment. Published research on auricular acupuncture for * Corresponding author. Tel.: +46-8-674-7600; fax: +46-8-16-26-00. E-mail address: anne.h.berman@chess.su.se (A.H. Berman). 0740-5472/04/$ – see front matter D 2004 Elsevier Inc. All rights reserved. doi:10.1016/S0740-5472(03)00162-4 prison inmates is scarce. Two of the authors recently published a pilot study on auricular acupuncture for prison inmates in psychiatric units (Berman & Lundberg, 2002). Unpublished studies in the prison setting generally suggest positive effects for auricular acupuncture participants according to a variety of dependent variables. One study found significantly lower re-arrest rates among 78 released inmates who had received five or more auricular acupuncture treatments (Brumbaugh & Wheeler, 1991). Another study, however, found no significant difference between rearrest rates among 29 women jail inmates who had volunteered for auricular acupuncture treatments, compared to a randomly selected untreated sample (Brumbaugh, 1992). Significantly reduced intra-prison charges and positive urine tests were found for acupuncture participants in Dartmoor prison in England compared to non-randomized controls. Other unpublished reports indicate reduced violent incidents for violent offenders at the San Francisco County Jail, reduced self-reported emotional discomfort for women at a Santa Clara County Correctional Center for Women, better self-reported health and no violent incidents for inmates at 96 A.H. Berman et al. / Journal of Substance Abuse Treatment 26 (2004) 95–102 the Denver County Jail and reduced self-reported emotional discomfort and intrusive sexual fantasies for sexual offenders at a Minnesota corrections facility (M. Smith, personal communication, 2002). A Swedish pilot study that inspired the present trial reported that 10 drug-dependent women inmates at a Swedish women’s prison who were randomly assigned to a 4-week treatment program with auricular acupuncture, or to a waiting-list control, showed significant positive post-treatment effects on worry [Swedish oro]. In addition, all participants maintained negative urine tests during the course of the treatment (Blow, Gyllenhammar, & Stevens, 1995). The relatively wider range of published research on auricular acupuncture in addiction treatment settings outside prisons describes controlled research on both inpatients and outpatients. Most studies have limited their samples to individuals abusing one particular substance, such as alcohol (Bullock, Culliton, & Olander, 1989; Bullock et al., 2002; Bullock, Umen, Culliton, & Olander, 1987; Sapir-Weise, Berglund, Frank, & Kristenson, 1999), heroin (Lipton, Brewington, & Smith, 1994), or cocaine (Avants, Margolin, Holford, & Kosten, 2000; Bullock, Kiresuk, Pheley, Culliton, & Lenz, 1998; Margolin et al., 2001), and have used a nonspecific acupuncture protocol as a control. Half of these studies have shown reduced intake of the substance and one or two other positive effects for the widely used NADAAcudetox1 protocol (Avants et al., 2000; Bullock et al., 1987, 1989; Lipton et al., 1994). The remaining studies have not found any difference between the NADA protocol and the control treatment (Bullock et al., 1998, 2002; Margolin et al., 2001; Sapir-Weise et al., 1999). One study focusing on the effect of a single session of ear acupuncture on psychological and physiological measures of drug craving among cocaine users found no difference between the experimental and control protocols (Killeen et al., 2002). The treatment-oriented approach of focusing upon groups of patients abusing particular substances, while used in addiction treatment settings, is at present not a priority for most prison authorities. Instead, inmates are identified as generic ‘‘drug users’’ and at best a differentiation is made between abuse of alcohol and abuse of drugs. Controlled studies on auricular acupuncture for outpatients with heterogeneous drug use have shown that adding acupuncture to already existing treatment programs for such drug users has led to more rapid abstinence from drugs (Konefal, Duncan, & Clemence, 1994), lower re-admission rates to a detoxification program (Shwartz, Saitz, Mulvey, & Brannigan, 1999) and better treatment retention (Russell, Sharp, & Gilbertson, 2000). Design objectives for the present study in the prison setting were to increase sample size in the prison setting, improve control procedures, establish a single-blind design, 1 Training in the NADA-Acudetox auricular acupuncture protocol is certified by the National Acupuncture Detoxification Association (NADA) and is available in the United States, Europe and Australia (NADA, 2003). and to collect qualitative data on treatment effects (Ter Riet, Kleijnen, & Knipschild, 1990). Specifically, our purposes in this study were: (a) to document the viability of an auricular acupuncture treatment program in the prison environment, (b) to test the widely used NADA-Acudetox protocol (Smith, 1979; Smith & Khan, 1988) against a non-specific control protocol, and (c) to investigate side effects by means of qualitative data on inmates’ experience of the treatment. We hypothesized that there would be a demand for an auricular acupuncture treatment program in the two prisons where the study took place. We also expected that the experimental NADA treatment would show superior effects compared to the helix control procedure. Finally, we hoped the qualitative results would expose possible negative side effects of the treatment and provide a more subtle description of positive effects previously described in clinical anecdotes. 2. Method The study was carried out between January 1997 and June 1998 at two medium-security institutions, one for women and the other for men, each housing approximately 45 inmates serving sentences lasting between 1 and 12 months. The study design was prospective, single-blind, with random assignment to treatment and repeated measures. The regional scientific ethical committee at Karolinska Institutet approved the study (#96-202). 2.1. Participants Study participants were recruited to a 4-week treatment program following an open information session given by the first author in the prison. The information session was held every 4 to 6 weeks during the study recruitment period of 18 months. Information brochures on the study were available to inmates in the office of the prison nurse and through the prison officers. Each inmate interested in voluntarily participating in the study signed a consent form that included the understanding that he or she could choose to leave the treatment program at any time with no obligation or consequences. Participants were told that the purpose of the study was to compare two auricular acupuncture treatment protocols, one of which had been successfully tested clinically but both of which were active treatments. The two protocols were presented as having the potential of being equally effective in view of the presence of active points on the helix of the ear (Oleson, 1995). Participants were informed that they would be randomly allocated to treatment according to one of the protocols. The NADA-Acudetox protocol was referred to as the ‘‘middle’’ treatment since three of the five needles are inserted in the concha of the ear and the non-specific protocol with five points on the helix of the ear was referred to as the ‘‘edge’’ treatment (both protocols are bilateral). A.H. Berman et al. / Journal of Substance Abuse Treatment 26 (2004) 95–102 2.2. Outcome measures Participants registered for the study by filling in three questionnaires. One was a simple drug use questionnaire, adapted for the study based on existing forms used in the Swedish Prison and Probation Administration and on that used by Stevens in Blow et al. (1995). The second was the Acupuncture Treatment Assessment Scale (ATAS), which was adapted for this study from a similar scale used by Blow et al. (1995). The dimensions measured on the ATAS were worry, muscle tension, drug craving, physical wellbeing and psychological well-being; the response scale consisted of 13 unnumbered boxes with the positive status on the left and the negative status on the right. The third questionnaire was a Swedish research version of the Symptom Check List 90 (SCL-90; Derogatis, 1994), as a measure of psychiatric status. During the treatment program, participants filled in the ATAS before and after each treatment session. Also, after the first and fourth weeks of treatment, participants filled in the four-question Treatment Credibility Scale (TCS; Vincent, 1990), translated with the author’s permission into Swedish for this study. Semi-structured questionnaires were constructed for personal interviews with the inmates before and after each 4-week treatment program. Treatment providers recorded the number of acupuncture treatments for each participant per 4-week program on a grid constructed for this purpose. Urine samples taken every other day at the men’s prison were analyzed locally for cannabis, amphetamines, benzodiazepines, and opiates on a Dade Bering Viva Drugs-ofAbuse Testing Analyzer. Urine samples were also collected before and after each inmate furlough. All positive urine tests were sent for verification to the Department of Forensic Chemistry at the National Board of Forensic Medicine. 2.3. Treatment procedure The choice of ear points has varied in earlier studies both for the NADA treatment and for the control protocol. According to the World Health Organization, control procedures need to be considerably improved for acupuncture research to provide results that can lead to evidence-based decisions (World Health Organization, 1995). For the experimental treatments in auricular acupuncture research, some studies have used three points in the NADA-Acudetox protocol with one body point: LI 4 (Avants, Margolin, Chang, Kosten, & Birch, 1995; Bullock et al., 1989). Others have used four points in the NADA protocol (Lipton et al., 1994; Margolin et al., 2001). Control ear points have been non-specific for drug use. Studies have used presumably inactive points placed 4 –5 mm from NADA points (Bullock et al., 1989) or 2 mm from NADA points (Avants et al., 1995). In the Lipton et al. (1994) study, non-specific points 4 mm from NADA points were also used, but they were chosen in areas corresponding to points active for diagnoses 97 other than drug abuse or dependence. Most recently, Margolin, Avants, and their colleagues recommended the use of control points in the helix of the ear, an area clearly remote from the inner ear area of the NADA points (Avants et al., 1995, 2000; Margolin, Chang, Avants, & Kosten, 1993; Margolin et al., 2001). In this study, all five NADA-Acudetox points (Shen Men, Sympathetic, Kidney, Liver, Lung) were chosen for the experimental treatment in order to follow standard clinical practice. The control protocol consisted of five points on the helix of the ear, placed on a line stretching from just under Darwin’s tubercle down to the area on the helix corresponding to an anterior line drawn from the antihelix tail. Stainless steel disposable needles (0.22  0.13 mm), manufactured by the Suzhou medical appliance factory in China, were inserted according to standard procedure just under the skin at each of the five points on both ears. Each treatment session lasted approximately 40 min with women reclining in adjustable lawn-type chairs and men lying on mats on the floor of the prison gymnasium. A choice of approximately 10 music tapes was available to both groups. A spoken guided relaxation tape was also available to the women. 2.4. Study procedure Once participants had registered for the study, they were individually interviewed by the first author. Contraindications for treatment were local inflammation of the ear, pregnancy, and pre-psychotic or psychotic states as indicated by the Psychotic Scale of the SCL-90 or according to prison medical staff observations. Three acupuncturists with experience of the NADAAcudetox protocol administered the treatment, one nurse and one non-medically trained prison officer in the women’s prison and one nurse in the men’s prison. Both nurses were also trained in acupuncture according to traditional Chinese medicine. The acupuncturists were trained in the nonspecific helix control procedure at a 1-day session with a followup session 6 months later. Random allocation to one of the two treatment groups was done in a manual lottery by the first author. Acupuncturists were informed of group assignment just before the first treatment date. The treatment program consisted of 14 sessions. Five sessions were given during the first week of the program, and three sessions were given during each of the following 3 weeks. Following the end of the fourth week of treatment, the first author returned to the prison and interviewed all inmates who had participated in the program, including those who dropped out before completing 14 treatments and who were still serving their sentences.2 On this occasion a new information session was held and a new group of 2 Some final interviews were carried out by telephone when the inmate was unavailable for an interview during the project leader’s visit to the prison or when the inmate was no longer at the prison. 98 A.H. Berman et al. / Journal of Substance Abuse Treatment 26 (2004) 95–102 participants was also interviewed. The number of participants in each new group varied between 5 and 12. 3. Results 3.1. Participants and baseline scores A total of 174 inmates registered for participation. No registered participants were excluded from the study based on the contraindications. One of the authors, a psychiatrist, was consulted in two cases of high scores on the Psychotic Scale of the SCL-90. In both cases, a decision was made to allow participation. Of the eligible sample, 11 who did not use drugs were excluded from analysis. Randomization was carried out for 163 intent-to-treat (ITT) participants, but the randomization results were lost for five persons, who were excluded. The analyzed ITT sample thus included 158 participants who were assigned to treatment with the NADA protocol (n = 82, 52%) or the helix control protocol (n = 76, 48%). Participants were allowed to remain in the study even if they missed a treatment. We measured the total number of treatments received over the 4-week study period. Treatment completers were defined as participants who received 10 treatments or more, in line with standard practice for initial acupuncture treatment, which stipulates between 8 and 12 sessions (Stux & Pomeranz, 1998).3 Participants who received fewer than 10 treatments were referred to as dropouts. In the NADA group, 39% completed treatment, compared to 58% in the helix group ( p < .05). Fig. 1 shows the flow of participants through the study. The ITT sample included 61% men (n = 97) and 39% women (n = 61), with a mean age of 33.5 years. Most participants were 25 –44 years old (80%), with 12% under 25 and 8% over 45 years old. The self-reported drug of preference was amphetamine for 51% of the participants, heroin for 12%, cannabis for 10%, a combination of amphetamines and cannabis for 8%, alcohol for 8%, hypnotics, sedatives or analgesics for 3%, and poly-drug use for 3%. Data on drug preferences were unavailable for 7% of the ITT sample. No differences in gender, age, or preferred drug were noted between the experimental and control groups. Baseline data on the SCL-90 and the ATAS by treatment retention and method were available for most of the ITT sample. Among dropouts, baseline scores indicated more anxiety, phobic anxiety, and global severity of symptoms on the 3 Among the treatment completers, one man in the helix group who had severe sleep disturbance participated in all 14 auricular acupuncture sessions but body acupuncture points Yintang, DU20, LI4 and LU7 were added at the 7th to 14th treatments. A man in the NADA group experienced pain in one ear and was treated unilaterally between the 2nd and 8th sessions. These two participants both completed all 14 sessions and they were retained in the data sample. Their inclusion did not influence the overall results. SCL-90 for the helix group. Baseline ATAS scores confirmed that helix group dropouts experienced more worry and lower physical and psychological well-being than NADA-group dropouts. Among the treatment completers, no differences were noted except for a tendency to higher depression scores on the SCL-90 for the helix completers. Three findings regarding gender are worth noting. Men in the dropout group scored significantly higher than women on the Hostility scale of the SCL-90 ( p < .01), and they tended to score higher than women on the Paranoid Ideation scale ( p < .10) Among treatment completers, women tended to show worse subjective physical well-being according to the ATAS ( p < .10). 3.2. Outcome scores Only treatment completers with complete data on each outcome measure (see Fig. 1) were included in outcome analyses. Missing data among treatment completers was due to poor documentation at the prisons or because participants were not at the prison on the day of the last treatment or at the followup interview. Repeated measures analyses of variance on the five ATAS items and the nine SCL-90 dimensions showed no differences by method. However, post-treatment scores on the ATAS and the SCL-90 dropped significantly for both groups compared to baseline scores (effect sizes .46 – .75 for the ATAS and .26– .68 for the SCL-90). Following each of the first 10 treatment sessions, scores on a composite index of the ATAS dropped significantly for both groups, with no difference by method. A repeated measures analysis of variance on the TCS items showed a within-subjects interaction on confidence by method ( F = 7.99, p < .01), where confidence in treatment increased over time for participants in the NADA group (from M = 3.9, SD = 1.2 to M = 4.3, SD = 1.3) and decreased over time for participants in the helix group (from M = 4.1, SD = 1.2 to M = 3.9, SD = 1.2; see Fig. 2). No effects on the remaining TCS items occurred. 3.3. Drug use Drug use was analyzed non-parametrically, using a dichotomous dependent variable indicating whether or not drug use occurred during the 11 treatment program blocks over the 18-month trial. Total abstinence from drug use for both the helix and the NADA groups occurred in 8 of the 11 program blocks. Compared to the helix group, where no drug use at all was found, 27% of the NADA participants gave positive urine tests during the study (m2 = 8.68, p < .01). Four of the six NADA participants who used drugs during the program were from the same program block, however, suggesting that the drug use could have been a phenomenon particular to that group. When all participants in that program block were dropped from analysis, a tendency remained for increased drug use in the NADA group A.H. Berman et al. / Journal of Substance Abuse Treatment 26 (2004) 95–102 99 Fig. 1. Participant flow diagram in a randomized controlled trial of the NADA-Acudetox protocol among men and women in prison. * Treatment completers are defined as all participants who received 10 or more treatments. (m2 = 3.03, p < .10), based on positive urine tests for two participants from two separate program blocks. 3.4. Side effects According to pharmaceutical praxis, negative side effects can be divided into two categories: Type A effects directly related to the pharmaceutical characteristics of a medication, and Type B effects resulting from non-pharmacological mechanisms such as immune system or allergic responses (FASS, 2000). For auricular acupuncture, parallel Type A effects would be pain at needle insertion, dizziness or blood pressure changes. An example of parallel Type B effects could be triggered psychotic states. Regarding Type A effects, we found that about 26% of participants in the intent-to-treat sample dropped out because of pain at insertion. Among the treatment completers, two participants (one from each group) completed treatment even though they found it painful. These two had unusually high scores on the Global Severity Index of the SCL-90 compared to other participants who discontinued treatment earlier because of pain ( F(2,14) = 4.17; p < .05). As for Type B effects, we closely followed five treatment completers with comparatively high scores on the Psychoticism dimension of the SCL-90. We found that the scores on this dimension dropped significantly for all five participants after treatment (t = 4.0, p < .05). Observations by the acupuncturists and prison staff seemed to confirm that possible psychotic tendencies were reversed rather than exacerbated. Interview results based on 73 pre-treatment interviews and 69 post-treatment interviews with treatment completers showed one notable positive side effect of the treatment: improved nighttime sleep. Among NADA treatment 100 A.H. Berman et al. / Journal of Substance Abuse Treatment 26 (2004) 95–102 Fig. 2. Confidence in treatment over time according to the Treatment Credibility Scale (Vincent, 1990) for prison inmates who completed treatment with a helix control protocol (n = 33) or with the NADA protocol (n = 26); ( F = 7.99, p < .01). completers, 77% indicated they slept better, and 50% of the helix treatment completers reported the same effect. 4. Discussion This study was unique in that we conducted a randomized controlled trial in a prison environment over a period of 18 months. We found no major differences between the two auricular acupuncture protocols tested, in line with similar previous findings for alcohol and cocaine users in outpatient settings (Bullock et al., 1998, 2002; Margolin et al., 2001; Sapir-Weise et al., 1999). One of the motivations for conducting the study was a concern among medical staff in the Prison and Probation Administration that the prison population, already more vulnerable (Fazel & Danesh, 2002; Nilsson, 2002), would be negatively affected by a complementary medical treatment such as auricular acupuncture. We found no evidence for their concerns, noting only transitory pain at needle insertion, which was either resolved by dropout or tolerated. An independent study on the ethical parameters for inmates in our study found that participation was perceived as fully voluntary (Lynoe, Sandlund, & Jacobsson, 2001). A pressing concern among prison administrators is how to reduce drug use among prisoners. Our findings indicated that auricular acupuncture treatment was associated with total abstinence from drug use in the helix group and 73% abstinence in the NADA group. No controlled comparison to an untreated group was available.4 Comparisons of abstinence figures from four acupuncture studies on auricular acupuncture for cocaine addicts show higher abstinence rates in the eighth week of treatment for participants 4 Urine test data for inmates who did not participate in the study showed significantly lower abstinence rates compared to participants. However, since no baseline data were collected for non-participants, these results are not interpreted. receiving acupuncture and coping skills training (CST), compared to CST only, acupuncture only and methadone maintenance only (57%, 40%, 15% and 10% respectively; Margolin, 2003). Similar findings were reported in a randomized controlled study among voluntary or court-mandated heterogeneous drug users, who showed better abstinence rates when acupuncture was added to a 16-week group counseling intervention with frequent urine testing (Konefal et al., 1994). Previous research has shown that total abstinence in an auricular acupuncture treatment group for active drug users may be an unrealistic goal. The relatively high abstinence rates observed in our study may be explained by the limited accessibility of drugs in prison. In order to answer the question of whether auricular acupuncture treatment contributes to reduced drug use in the prison setting, future studies should gather baseline and urine test data on inmates who do not volunteer for treatment in order to allow comparison with untreated groups. Also, in view of the positive findings reported when acupuncture is added to ordinary treatment offerings (Konefal et al., 1994; Russell et al., 2000; Shwartz et al., 1999), future studies studying retention and abstinence from drugs should add a treatment group with structured psychosocial treatment focusing on specific drug abstinence coping strategies. A second focus of this study was reducing symptoms of personal discomfort for drug users in prison. While we found no differences between the two methods, we did see a significant positive reduction over time in self-reported symptoms of physical and psychological discomfort. In the absence of an untreated comparison group, we do not know whether the observed changes over time were due to the natural course of time, the prison setting, participation in a research study, specific readiness to change among study volunteers, or an active acupuncture effect for both treatments. Furthermore, with our present design, non-specific treatment-related factors such as music, dimmed lights, and a welcoming attitude on the part of the treatment providers, A.H. Berman et al. / Journal of Substance Abuse Treatment 26 (2004) 95–102 were inextricable from acupuncture effects. We agree with Bullock et al. (2002) that placebo and other non-specific effects related to situational variables are extremely difficult to disentangle. The nature of the placebo effect is difficult to specify and may have much to do with the relationship between the treatment provider and receiver (Vincent & Furnham, 1997). However, the placebo effect in itself is not a disadvantage but rather can enhance and prolong active treatment effects (Boström, 1997). One recent large study included a non-invasive relaxation control in an attempt to isolate placebo effects, with negative results (Margolin et al., 2001), but another study found better results for NADA participants compared to needle and relaxation controls (Avants et al., 2000). These two studies differed in that participants in the former were offered payment as an incentive to remain in treatment and participants in the latter study were offered manualguided CST counseling without any payment incentive, suggesting that important aspects of the treatment context may influence acupuncture trial results (Margolin, Avants, & Holford, 2002). Future research should be designed so as to answer the question of whether auricular acupuncture, at the least, might offer a means of harnessing specified placebo effects for reducing the general personal discomfort caused by intensive drug use. Our finding of improved nighttime sleep for treatment completers (with an apparent advantage for the NADAAcudetox protocol), not previously reported, may be associated with similar previous findings on reduced anxiety (Bullock et al., 1998; Sapir-Weise et al., 1999). These findings may indicate support for the suggestion by Lipton et al. (1994) that auricular acupuncture might affect aspects of emotional health that are not specifically related to drug craving but to the general syndrome of anxiety and depression related to prolonged use of any substance. Pilot data indicating positive long-term effects may be also related to this broader effect spectrum (Berman & Lundberg, 2002; Gurevich, Duckworth, Imhof, & Katz, 1996). Again, however, we have not been able to disentangle any positive side effects from placebo effects. Some methodological issues that may have confounded our findings merit comment. One concern regarding our findings is how consistent the helix treatment was. We specified the helix protocol by instructing needle insertion at five points between Darwin’s tubercle and the area on the helix corresponding to an anterior line drawn from the antihelix tail. However, we did not specify avoidance of ‘‘liver Yang’’ points, as Avants et al. (2000) did in their study showing that NADA acupuncture patients addicted to cocaine were significantly more likely than needle-insertion controls and relaxation controls to provide cocaine-negative urine samples. It may also be of significance that all acupuncturists initially expressed a negative attitude towards treatment with the helix protocol, although their attitude changed when they observed that the study participants reacted positively to helix treatment. 101 Another issue is that treatment and control groups in our study were supposed to be separated according to the original design. However, about midway into the trial, small groups and organizational pressures at the prisons led to a merging of the two groups at both prisons. It is not clear what consequences this might have had for our results. Finally, the reader will have noticed the varying numbers of missing data in the ITT sample and in the analyzed TC sample (see Fig. 1). Although prisons are closed institutions, the inmates in our sample were sentenced to relatively short terms of confinement. This meant that interruptions in their commitments were regular occurrences, due to externally imposed factors such as work, study, recreational activities or medical care, or post-release planning related visits outside the prison. Resolving this obstacle to effective controlled research in prisons is a significant challenge for the future. This study presents findings from one randomized controlled trial on auricular acupuncture in the prison setting. We found a demand for auricular acupuncture among prison inmates, and no negative side effects for the treatment. However, our study did not yield any major evidence for the superiority of the NADA protocol compared to the helix control protocol nor for the reverse. Despite the present findings, the body of literature concerning auricular acupuncture still indicates that it may be of potential value in relieving personal discomfort, improving treatment retention, and increasing abstinence from drugs, particularly as an adjunct to structured, intensive psychosocial treatment. The issue of placebo effects in both the NADA and nonspecific protocols was not addressed by this study. Future research should include non-invasive controls in order to attempt to disentangle placebo from active effects. It seems vital to also include structured intensive drug use treatment in such research in order to further elucidate the possible contribution of auricular acupuncture to treatment retention and abstinence from drugs. Acknowledgments The Stockholm and Härnösand offices of the Swedish National Prison and Probation Administration provided financial support for the study. We thank Arthur Margolin, Ph.D., for comments on an earlier version of this manuscript. 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