Medications for the Treatment of Addiction – A Neurobiological Perspective

Clinical Trials – Unique Challenges and Opportunities

Double-blind, placebo-controlled trials with random treatment assignment are the accepted standard for determining drug efficacy in addiction, similarly to other disorders (see Box 9.2). However, a number of unique features of the clinical trials for medications for the treatment of addiction need to be mentioned. These include a lack of consensus about clinically relevant outcome measures, admission criteria, and methods for detecting relapse between study visits. Additionally, general issues related to medication compliance, placebo response, and drop-out rates present challenges for the design of clinical trials in addiction. Safety and tolerability issues also exist that are specific to addiction, including the potential interaction between alcohol and other substances with the drug under study (for further reading, see Koob et al., 2009).

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