Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Cocaine Dependence, sponsored by Yale University.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00585520 record still lists
NCT00585520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 297-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cocaine Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00585520's enrollment target sits among peer trials
60 24th of 38 higher than 15 of 38 other Cocaine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cocaine Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
RECRUITING · Phase 1
-
Glutamate-Glutamine Cycling (VCYC) During Cocaine Abstinence Using 1H-MRS
COMPLETED · Phase 1
-
Complementary Combination Therapy for Cocaine Dependence
COMPLETED · Phase 1
-
Rivastigmine and Huperzine A as Treatments for Cocaine Dependence
COMPLETED · Phase 1
-
Long Term Maintenance of Drug Abstinence
COMPLETED · Phase 1
-
Caffeine and Cocaine
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia