Rationale and design of the Cocaine Alternative Treatments Study (CATS): a randomized, controlled trial of acupuncture.

Acupuncture has been incorporated as a treatment component in numerous addiction treatment programs in the United States; however, its efficacy has not been demonstrated in large-scale, controlled clinical trials. In this article we discuss the background and design of the Cocaine Alternative Treatments Study (CATS), a randomized, controlled, multisite study of acupuncture that will enroll 500 cocaine-dependent individuals at 6 sites across the country, and that constitutes the largest controlled trial for the treatment of cocaine addiction undertaken to date. After presenting the background of the study, we discuss the approach taken to address several critical issues, including the choice of appropriate control conditions, point location for needle insertion, degree of blinding, and bias checks. Complementary therapies are used by a significant number of individuals, and the need to evaluate them in controlled clinical trials is an ongoing and urgent issue.