Cerecor announces initiation of second CERC-501 Phase II clinical trial in smokers
Study to evaluate the effect of CERC-501 on stress-related smoking lapse.
Cerecor has announced that Dr Sherry McKee from Yale University has enrolled the first subject in the Phase II clinical trial for CERC-501, “Does CERC-501 Attenuate Stress-Related Smoking Lapse?” The study is a collaborative effort between Cerecor and Dr McKee and is supported by funding from the National Institutes of Health (NIH). “Stress is a primary contributor to the maintenance of, and relapse to, smoking, and targeting stress-related relapse as a medication development strategy is a critical, yet relatively unexplored area of research,” says Dr McKee. "Preclinical findings suggest that the kappa opioid receptor system is involved in stress-induced relapse to tobacco and we anticipate that a receptor antagonist, such as CERC-501, has the potential to be of therapeutic benefit.”
The primary objective of the double-blind, placebo-controlled, crossover study is to evaluate whether CERC-501, compared to placebo, will increase the ability to resist smoking, and reduce subsequent smoking following overnight nicotine deprivation and personalized stress imagery in subjects who are heavy smokers. “We are enthusiastic about the potential use of CERC-501 for addictive disorders, including smoking cessation,” said Dr Ronald N. Marcus, Chief Medical Officer and Head of Regulatory Affairs at Cerecor.
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