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NCT00585520 · ClinicalTrials.gov registry record · Phase 1
Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues
A Phase 1 study of Cocaine Dependence, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00585520 is a Phase 1 study of Cocaine Dependence that has completed, run by Yale University. The registered enrollment target is 60 participants, below the 297-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00585520, a Phase 1 study of Cocaine Dependence, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Cocaine dependence is a chronic, relapsing disorder in which stress/negative mood and exposure to drug-related stimuli or "cues" are associated with high rates of relapse (McKay et al., 1995; O'Brien et al., 1998; R. Sinha, 2001; Shaham et al., 2003). In particular, sex differences in relapse precipitants have been noted, with women reporting greater stress related relapses while men report higher number of relapses associated with drug cue/temptation situations (Lex, 1991; McKay et al., 1996; R. Sinha, 2001; R. Sinha, Rounsaville BJ, 2002). Current SCOR studies have shown that stress and cocaine cues increase drug craving and stress related arousal, responses that differ in cocaine men and women (R. Sinha et al., 2003; H.C. Fox et al., 2005a). Furthermore, stress-induced cocaine craving and HPA responses are predictive of cocaine relapse, which is also moderated by gender (R. Sinha et al., 2006). However, no previous research has examined the basis of sex differences in stress and cue induced craving and arousal, both of which are known to increase relapse susceptibility. Greater knowledge of the sex-specific neurobiology of cocaine dependence will facilitate development of gender-specific cocaine relapse prevention efforts. Growing evidence supports a role for gonadal hormones in explaining the sex differences observed in stress responses as well as in the behavioral responses to cocaine (Festa \& Quinones-Jenab, 2004; K. Carroll, Fenton LR, Ball SA, Nich C, Frankforter TL, Shi J, Rounsaville BJ, 2004; Lynch, 2006; Kajanti \& Phillips, 2006). Estrogen increases behavioral responses to cocaine, while presence of progesterone decreases subjective and behavioral effects of cocaine, more so in females than males (Jackson et al., 2006; Sofuogu et al., 1999; M. Sofuoglu et al., 2002; Evans \& Foltin, 2006). Stress and cocaine each enhance brain stress circuits, namely the corticotrophin releasing factor (CRF)-hypothalamic-pituitary-adrenal (HPA) axis and central noradr
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Progesterone
Study Locations (1)
Connecticut
- Yale University School of Medicine: Research Program on Stress, Addiction, and Psychopathology - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-09 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00585520
The ClinicalTrials.gov registry entry for NCT00585520 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 297-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (80% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cocaine Dependence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00585520 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT00585520 about?
NCT00585520 is a clinical study titled "Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues". Cocaine dependence is a chronic, relapsing disorder in which stress/negative mood and exposure to drug-related stimuli or "cues" are associated with high rates of relapse (McKay et al., 1995; O'Brien et al., 1998; R. Sinha, 2001; Shaham et al., 2003). In particular, sex differences in relapse precip...
What is the current status of trial NCT00585520?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2007-09. Estimated completion is 2013-09.
What conditions does trial NCT00585520 study?
This clinical trial studies the following conditions: Cocaine Dependence.
What interventions are being tested in trial NCT00585520?
The interventions under investigation include: Placebo (DRUG), Progesterone (DRUG).
Who is sponsoring clinical trial NCT00585520?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00585520 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.