Big Cocaine Study Can't Include Pregnants

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BIG COCAINE STUDY CAN'T INCLUDE PREGNANTS

While a much-anticipated big study on efficacy of acupuncture for addiction is mostly on track, study leaders have given up on trying to include a sample of pregnant drug users. Herbert D. Kleber, MD, principal investigator of the Cocaine Alternative Treatment Study (CATS), said, "In spite of trying it in four different cities with a variety of different outreach approaches, we had an extraordinarily difficult time in enrolling enough women for the project."

This failure probably has nothing to do with acupuncture, but is consistent with a long history of other failed efforts to involve pregnant persons in addiction treatment. In another recent example, five US states got special Medicaid funds to offer pregnant addicts a comely package of prenatal care, residential addiction treatment and case-managed support services. Even so, the project did not significantly increase the number of women accessing addiction or prenatal care, according to a government outcome study. The study authors blamed the recruiting gap on the usual things: social stigma and the brief time window of pregnancy.

The CATS researchers have succeeded in enrolling subjects for the other two target populations for the three-year longitudinal study, Kleber explains. These are cocaine dependent methadone maintenance patients, and primary cocaine or crack addicts. The study has been underway since 1996 at six different sites. Two of the sites, at Yale University and the University of Miami, have completed subject enrollment, Kleber says. New subjects are still coming in to the sites at the University of Washington, at the Universities of California at San Francisco and Los Angeles and the Hennepin County Medical Center in Minneapolis.

After enrollment, subjects undergo eight weeks of treatment for cocaine addiction, with followup contacts scheduled at three months and six months. On this schedule, the main data collection process could continue at some of the sites into middle 1999, or later. However, Kleber estimates that initial findings from the project could begin to appear in professional journals as early as next Spring.

Other than being disappointed about not enrolling pregnant patients, Kleber says he is pleased with the overall status of the project at this time. He considers it remarkable that the project was not only able to raise the $3.5 million-plus dollars needed to pay for it, but also to make the complex arrangements needed for a multi-site study by competent scientists.

Interested parties in and out of the acu detox field have looked to CATS as promising definitive findings about the value of acupuncture in treating addictions. Funding for the work comes not only from the mainstream Conrad N. Hilton Foundation, but also from the office of the US government's drug czar. Kleber himself, and his organization, the Center for Addiction and Substance Abuse (CASA) at Columbia University, are at the top of world stature in alcohol and drug problem research.

Initial reports on the study will issue from CASA and represent material on the overall project. Individual study sites will have opportunities later to compare and contrast their particular data with that from the other sites. Kleber says that blinding of data is still fully in effect, and nothing is known at this time concerning project findings.

The study's method compares the outcomes for patients given random assignment to one of three modes of treatment. Two of these modes involve different types of ear-point needling. The first type is according to the widely-used protocol developed since the '70s by Michael O. Smith, MD, DAc, and his National Acupuncture Detoxification Association (NADA) colleagues. The second type uses needling in zones of the ear not used by NADA. The third group of patients undergoes regular sessions of a relaxation experience, comparable to the acupuncture sessions in length of time spent, but without any needling.

Finding suitable alternate needling areas for the second acupuncture group turned out to be a challenge. This was because prior research had shown that needling such alternative zones may also produce a treatment effect. Dealing with the problem required CATS to set up a preliminary research project, conducted by the experienced acupuncture investigators at the Yale University CATS site. This group eventually identified zones on the helix of the auricle that, by seeming to be relatively inactive, could serve as a control. (See Guidepoints, June, '97).

Besides the problem of an adequate control treatment, CATS researchers may encounter other challenges that have characterized acu detox research. For one, patients from these target populations have historically shown high rates of dropping out before completing an intended course of treatment and follow up. Early reports indicate that the different study sites have tried a variety of anti-drop out strategies, and the results may be equally various.

Also, all patients in the study are to receive a uniform course of chemical dependency counseling services along with the needling or relaxation. But some of the sites could rely on their existing ties to such counseling services while others had to make new arrangements. This factor, too, could result in cross-site discrepancies.

Deepest uncertainty, however, probably comes from those who doubt that the healing impact of acu detox, so often reported anecdotally, can show itself adequately within the confines of the randomized, controlled, clinical trial (RCT) method of Western science. Experienced acupuncture researchers such as Milton L. Bullock, MD, himself a clear exponent of Western scientific method, have stated that methods other than RCT may have to be used to capture the clinical effects of acupuncture treatment of addiction.

A look at the relation between counseling and acupuncture shows one important way in which the CATS design varies from the usual clinical practice of NADA-style clinics. The CATS protocol sharply divides these two functions, with little or no contact between the two types of clinical personnel. CATS also specifies that the acupuncture providers are to restrict their services to needling alone. This is in contrast to NADA practice, wherein acu clinicians commonly also give informal support, verbal and non-verbal.

J&M Reports, LLC.

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