Cocaine Effect Study Ponders Research Methods

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COCAINE EFFECT STUDY PONDERS RESEARCH METHODS

Two big puzzles facing acupuncture for addictions researchers may be nearing solution in New Haven. The first -- why have a number of recent controlled studies failed to show much of a difference between "real" and "sham" acupuncture? The second -- how can research findings avoid being impaired by high drop out rates among subjects?

Yale University School of Medicine now harbors the premiere team of acupuncture addiction researchers, measured both in number of publications and in infra-scholarly connections with the mainstream world of addiction research. A new report is the team's latest in a series of ingenious but methodical tries at measuring what some Eastern wisdom enthusiasts say is unmeasurable.

In a blinded clinical trial, two groups of hard core addicts showed significant and almost identical improvement in both cocaine use and well-being after access to six weeks of five-days-a-week acu treatments. One of the groups received what the researchers call "active" needling and the other "control" needling in nearby points. A large percentage of the subjects, compared to those in many previously anecdotal and controlled studies, finished the full treatment course. Subjects could not detect which of the two alternate treatments they were getting and both groups felt that acupuncture could help them with their drug problem.

The authors present their findings as more evidence that the search for a dependable "control" form of needling for blinded acu studies has further to go. Needling near the "active" points probably has too much of a similar effect. They project plans to try points further away still, perhaps on the helix of the ear.

Twenty-two men and 18 women subjects (60% white, 35% African American, 5% Hispanic) were stable methadone patients sharing the characteristics of unemployment, long term use of both opiods and cocaine, and current cocaine dependence. After volunteering for the program, they received random assignment to "active" acu treatment (similar to what is most commonly used in the acu care field -- "NADA-style") or to treatment in ear points slightly off-site from the usually specified NADA points. Researchers verified the selected ear points with a galvanometer -- active points registering high conductivity and control points low. In most respects, the protocol resembled the pioneer studies from Minnesota by Bullock, Culliton, Olander, et al.

The study team monitored cocaine use by twice-weekly urinalysis and self report. Subjects responded to questionnaires on psychological and addiction symptoms at the beginning and end of the study period. They were asked weekly for their subjective reactions to the needling itself in terms of mood, energy levels, pain, etc.

The only members of the study team who knew which subjects were in which treatment group were the two acupuncturists, both of whom had extensive training in both general acupuncture and the treatment of drug-addicted populations. Departing from the NADA model, needling sessions occurred with the subjects lying down in semi-isolated treatment rooms, rather than sitting up in groups. The two groups did not differ significantly in their personal characteristics, nor did the subjects who dropped out differ from those who completed.

Here is yet another strict clinical trial giving echo to the anecdotal reports of those working clinicians who feel that acupuncture gives them a powerful tool in facilitating the cessation of drug use. The report derives from a group with almost uniquely high credibility, not only in traditional Western-style drug research circles, but among alternative/complementary scholars as well. (One of the study team is currently president of the Society for Acupuncture Research). Sites in California, New York, Minnesota, Connecticut, Washington and Florida have now contributed controlled clinical trials which give support to the general direction that acu care has been going since the early 1970s.

In methodological terms, the study adds yet more force to the trend of acu researchers to look for a different type of acu "control" than ear points proximal to the "active" addiction points. The care and credibility of the study will no doubt strongly influence the design of the three-year, multi-site trial of acu care soon to begin under the auspices of the Center for Addiction and Substance Abuse. Compared to most previous studies, a very high proportion (75%) of the Yale subjects completed the treatment course, getting an average of three treatments a week, and dropping their rate of positive urine screens from 93% at baseline to 55% after six weeks. Hard core addicts by any measure, they reported statistically significant improvements in depression and other psychological symptoms as well as craving. They expressed hope that the treatment could and would help them. As working clinicians have these kinds of well-established data in mind, they will enhance their capacity to transmit similar hope to clients on their current caseload.

This documented high completion rate with such a problematic population can stiffen the resolve of program administrators to look more deeply into what it is about their present procedures that could be helping or hurting retention. The Yale group reveals little in this study about what specific measures they believe may affect retention, yet the improvement over their own prior reports indicate that some learning is going on. One can look forward to the team's future reports.

The only statistically significant difference between the study groups was that the subjects getting the "active" treatment reported a greater decrease in craving.

Of the 40 subjects in the study, 18 were HIV-positive. Compared as a whole against all the HIV-negative subjects, regardless of group assignment, they responded better on some study measures, notably completion, positive urine samples, and initiation of abstinence.

The experimenters addressed the problem of trying to isolate the effect of acupuncture from the other study-related experiences which the subjects had that might have been therapeutic, such as staff attention, regular urine screens, and the relaxation benefits of lying down for 45 minutes during the treatment. While they suggest in future studies adding a relaxation control group, they warn: "Given the present state of our knowledge concerning acupuncture, there is no obvious way to definitively (emphasis theirs) resolve issues concerning the effect of placebo response on treatment outcome."

Though this study, in having the subjects semi-isolated and lying down during needling, departed in a major way from the NADA protocols, the authors recommend that future acu studies on cocaine addiction be conducted according to the seated, group treatment method "as is the standard procedure at Lincoln Hospital."

Article copyright J&M Reports, LLC.

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