A single-day paradigm of self-regulated human cocaine administration |
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Authors: | D Matuskey B Pittman J I Chen J Wanyiri H Nadim P Jatlow R Gueorguieva M N Potenza P T Morgan Z Bhagwagar R T Malison |
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Institution: | a Department of Psychiatry, Yale University, New Haven, CT, USAb Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, CT, USAc Department of Laboratory Medicine, Yale University, New Haven, CT, USAd School of Medicine and School of Epidemiology and Public Health, Yale University, New Haven, CT, USAe Substance Abuse Center, Connecticut Mental Health Center, New Haven, CT, USAf Department of Neurobiology, Yale University, New Haven, CT, USAg Child Study Center, Yale University, New Haven, CT, USAh Bristol-Myers Squibb, Wallingford, CT, USA |
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Abstract: | Prior work by our group has shown the feasibility, safety, and validity of a multi-day, multi-dose paradigm of self-regulated cocaine administration in humans. The current work sought to consolidate these methods in a single-day design focused on reducing logistical complexity, decreasing research burden to human subjects, and increasing suitability for medication development designs.MethodsEleven experienced cocaine users participated in a 6-hour, single-day design, consisting of one safety/eligibility and three experimental cocaine periods (during which subjects were allowed to self-administer 8, 16, and 32 mg/70 kg cocaine doses under a fixed-ratio 1:5 minute timeout schedule). Changes in cocaine-induced cardiovascular response, self-administration behavior, and subjective effects were assessed.ResultsProcedures were well tolerated by participants, and no significant adverse events were noted. Significant (p < 0.05), changes in measures of cocaine self-administration (e.g., responses, infusions, interinfusion intervals, consumption, and plasma levels), cardiovascular response (HR), and subjective effects (“high”) were observed. In contrast, cocaine-induced increases in other vital signs (e.g., SBP, DBP) and subjective effect measures (e.g., paranoia) did not differ between doses.ConclusionsThese data support the safety, tolerability and validity of our single-day design. Depending on the application, such methods may afford advantages for assessing the self-regulation of cocaine administration behavior in humans (e.g., including medication development designs). |
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Keywords: | Cocaine self-administration Human studies Self-regulation Cocaine plasma levels Subjective effects |
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