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Physiological Doses of Progesterone Potentiate the Effects of Triazolam in Healthy, Premenopausal Women

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Physiological Doses of Progesterone Potentiate the Effects of Triazolam in Healthy, Premenopausal Women Psychopharmacology (2011) 215:429–439 DOI 10.1007/s00213-011-2206-7 ORIGINAL INVESTIGATION Physiological doses of progesterone potentiate the effects of triazolam in healthy, premenopausal women Shanna Babalonis & Joshua A. Lile & Catherine A. Martin & Thomas H. Kelly Received: 13 January 2010 /Accepted: 27 January 2011 /Published online: 25 February 2011 # Springer-Verlag 2011 Abstract The subjective, performance and physiological effects of Rationale Gender plays a critical role in the effects of drugs progesterone, alone and in combination with triazolam, were and drug abuse liability. Biological factors, including assessed. ovarian hormones, may contribute to gender differences in Results Triazolam alone produced prototypical sedative- drug abuse. Preclinical and some clinical research suggests like effects. Progesterone alone also engendered some that progesterone and its metabolites have activity at the sedative effects, although the time course of the effects GABAA receptor and may enhance the effect of GABAer- was more limited than that of triazolam. Progesterone gic compounds (e.g., benzodiazepines). Because women increased and extended the duration of triazolam effects and are exposed to varying levels of progesterone from puberty delayed the onset of triazolam peak effects, most notably at until menopause, and appear more sensitive to the negative the 0.12 mg/70 kg dose. consequences of benzodiazepine use, it is important to Conclusions Progesterone potentiates the behavioral effects understand the impact of progesterone on GABAergic drug of benzodiazepines and may contribute to benzodiazepine effects. use and abuse among women. Objectives The purpose of this experiment was to charac- terize the behavioral effects of progesterone, alone and in Keywords Progesterone . Prometrium . Neurosteroid . combination with the short-acting benzodiazepine, triazo- Benzodiazepine . Triazolam . Subjective effects . lam, to determine if progesterone potentiates the behavioral Performance effects . Women’s health effects of triazolam. Methods Oral micronized progesterone (0, 100, and 200 mg) and oral triazolam (0.00, 0.12, and 0.25 mg/ Introduction 70 kg) were administered to healthy, premenopausal women (n=11) under conditions of low circulating sex hormones. Gender differences in drug use and abuse are notable, with : : greater numbers of men reporting non-medical use of drugs S. Babalonis (*) J. A. Lile T. H. Kelly than women (Substance Abuse and Mental Health Services Department of Behavioral Science, College of Medicine, Administration 2009). However, the relative risk of University of Kentucky Medical Center, Lexington, KY 40536-0086, USA developing dependence on sedative-hypnotic drugs (e.g., e-mail: [email protected] benzodiazepines) appears to be greater for women. After : initiating sedative-hypnotic drug use, women are signifi- C. A. Martin T. H. Kelly cantly more likely to develop problematic use patterns Department of Psychiatry, University of Kentucky Medical Center, relative to their male counterparts, such that women may be Lexington, KY, USA nearly twice as likely to develop dependence on these : compounds (Anthony et al. 1994; Kandel et al. 1998). In S. Babalonis T. H. Kelly addition, women are prescribed sedative-hypnotic com- Department of Psychology, University of Kentucky College of Arts and Sciences, pounds at higher rates than men (Wysowski and Baum Lexington, KY, USA 1991; van der Waals et al. 1993; Howes et al. 1996; 430 Psychopharmacology (2011) 215:429–439 Nomura et al. 2006), take the medications longer once lam, lorazepam, and triazolam (Kroboth et al. 1985). There prescribed (Geiselmann and Linden 1991), and are more do not appear to be any studies that have examined the likely to use the medications for non-medical purposes independent effects of progesterone on the behavioral (Simoni-Wastila et al. 2004). effects of sedative-hypnotic drugs in premenopausal wom- Multiple sources of evidence suggest the neurosteroid en. The purpose of the present study was to determine the progesterone and its metabolites might contribute to gender subjective and psychomotor effects of progesterone and differences in sedative-hypnotic drug abuse. Progesterone is triazolam, alone and in combination, in healthy adult abundantly present in premenopausal women, with plasma premenopausal women during the early follicular phase of concentrations varying as a function of menstrual cycle the menstrual cycle when ovarian hormone levels are at phase. Progesterone and its primary and derivative metab- their nadir. olites, allopregnanolone and tetrahydrodeoxycorticosterone (TH-DOC), modulate the GABAA receptor complex, which Participants is also the primary mechanism of benzodiazepine effects (Lena et al. 1993; Pluchino et al. 2006). Allopregnanolone Healthy, adult premenopausal women were recruited via and TH-DOC are ligands at extracellular, steroid-specific local newspaper advertisements and with flyer postings on recognition sites on GABAA receptors, with affinities that a university campus. All potential participants completed an are comparable to those of many benzodiazepines (Paul and initial telephone or internet-based questionnaire, and select- Purdy 1992). In addition, these neurosteroids dose- ed respondents were invited for an on-site medical dependently increase the effects of benzodiazepines on evaluation that included health history and psychological GABA-induced Cl− currents, indicating that there is a non- questionnaires, blood chemistry, and urinalysis. Urine genomic, receptor-level interaction between benzodiaze- samples were also screened for drugs of abuse and pines and neurosteroids (Paul and Purdy 1992; Bertz et al. pregnancy. Eligibility criteria included age (18 to 35 years), 1995). The behavioral effects of these neurosteroids also ability to speak and read English, occasional sedative drug overlap with those engendered by benzodiazepines and use (e.g., alcohol), and use of an oral, hormone-based include sedation, memory impairment, anxiolysis, depres- contraceptive that included a 7 consecutive-day placebo sion, stress reduction, and anti-seizure effects (Schumacher phase. Exclusion criteria included significant medical et al. 1989; Schumacher and Robert 2002; Rupprecht 2003; history (e.g., cardiovascular, neurological, or major psychi- Pisu and Serra 2004; Rhodes and Frye 2004). Finally, the atric illnesses, including drug or alcohol dependence), behavioral effects of GABAergic drugs are enhanced abuse or regular use of drugs or alcohol, pregnant or during menstrual cycle phases in which progesterone levels breastfeeding status, or any other condition that would are elevated. For example, the discriminative stimulus increase risk for study participation. The Institutional effects of ethanol in nonhuman primates (Grant et al. Review Board of the University of Kentucky Medical 1997; Green et al. 1999) and triazolam in humans Center approved the study and the informed consent (Babalonis et al. 2008) are enhanced during the mid-luteal document. The study was conducted in accordance with phase of the menstrual cycle when progesterone levels the ethical standards of the 1964 Declaration of Helsinki surge. However, menstrual cycle modulation of GABAergic (2008). All subjects provided sober, written informed drug effects have not been replicated across all studies consent and the confidentiality of their personal information (Rukstalis and de Wit 1999; Holdstock and de Wit 2000) was maintained throughout. Participants were compensated and may depend on the experimental conditions (e.g., for their participation. behavioral measures, drugs, and/or doses that are tested). Although examining drug effects across the menstrual Design cycle is a useful method to examine the modulating effects of endogenous ovarian hormones, it does not permit an A double-blind, placebo-controlled, randomized, counter- examination of the direct effects of progesterone, as balanced repeated-measures design was used to assess multiple hormone levels change simultaneously across the the subjective, performance and cardiovascular effects of cycle. An alternative strategy is to examine the direct progesterone dose (0, 100, and 200 mg), triazolam dose effects of exogenous progesterone administration. For (0.00, 0.12, and 0.25 mg/70 kg), and time (30, 60, 90, example, pre-treatment with exogenous oral micronized and 120 min after triazolam administration, which progesterone enhanced the sedative, memory, and perfor- correspond to 75, 105, 135, 165, and 195 after mance effects of intravenous triazolam in postmenopausal progesterone administration)duringtheearlyfollicular women (McAuley et al. 1995). In addition, combined phase of the menstrual cycle, when estrogen and administration of progesterone and estradiol enhanced progesterone levels are at their nadir. This study sensitivity to the performance impairing effects of alprazo- consisted of nine experimental sessions. Psychopharmacology (2011) 215:429–439 431 Drugs that was tested for recent use of amphetamine, barbitu- rates, benzodiazepines, cocaine, marijuana, methadone, Doses of progesterone and triazolam were prepared by the methamphetamine, MDMA, and opiates (E-Z Split Key University of Kentucky Investigational Pharmacy. Proges- Cup; ACON Laboratories, San Diego, CA, USA), and terone (0, 100, and 200 mg; Prometrium®) and triazolam pregnancy (hCG One Step Pregnancy Test Device; (0.00, 0.12, and 0.25 mg/70 kg) were prepared in single Instant Technologies, Inc., Norfolk, VA, USA).
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