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

Acupuncture has been incorporated as a treatment component in numerous addi ction treatment programs in the United States; however, its efficacy has no t been demonstrated in large-scale, controlled clinical trials. In this art icle we discuss the background and design of the Cocaine Alternative Treatm ents Study (CATS), a randomized, controlled, multisite study of acupuncture that will enroll 500 cocaine-dependent individuals at 6 sites across the c ountry, and that constitutes the largest controlled trial for the treatment of cocaine addiction undertaken to date. After presenting the background o f the study, we discuss the approach taken to address several critical issu es, including the choice of appropriate control conditions, point location for needle insertion, degree of blinding, and bias checks. Complementary th erapies are used by a significant number of individuals, and the need to ev aluate them in controlled clinical trials is an ongoing and urgent issue.