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NCT01576874 · ClinicalTrials.gov registry record · NA
The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking
A NA study of Nicotine Dependence, sponsored by Kevin Gray, MD.
- Completed
- Registry status
- NA
- Development phase
- 144
- Enrollment target
- 1
- Study location
NCT01576874: Completed NA study of Nicotine Dependence, sponsored by Kevin Gray, MD.
NCT01576874 is a NA study of Nicotine Dependence that has completed, run by Kevin Gray, MD. The registered enrollment target is 144 participants, below the 185-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01576874, a NA study of Nicotine Dependence, has completed, sponsored by Kevin Gray, MD.
- COMPLETED
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the overall parent study is to determine the impact of gender and hormones (estradiol, progesterone, testosterone and cortisol) on responses to stress and smoking cues presented in daily, "real-world" cue presentations compared to a final cue session in a lab. In addition, in the portion of the study that incorporates clinical trials elements and is reported here, the study will examine the impact of a single dose of oxytocin (chemical produced in the body) versus placebo (inactive substance) on reactivity to a stress procedure (Trier Social Stress Task) in smokers. The overall parent study involves a cue presentation technology known as "CREMA" (Cue Reactivity Ecologic Momentary Assessment) which delivers four daily cue presentations to you on a handheld device during your everyday routine. Additionally, the study involves daily collection of saliva samples for hormonal testing. These daily procedures will provide information about the role of cues and hormones in daily life. The clinical trial portion of the study (reported here) consists of measures collected within the laboratory.
Primary Outcome
The TSST is the gold standard for evoking stress response in the laboratory. The participant must deliver a speech as though speaking to a group of hiring managers. The participant has 5 min to prepare, then three individuals unfamiliar to the participant (the audience) enter the room and are seated; the participant is instructed give the speech (without notes). The speech is delivered for 5 min, then the participant is instructed to serially subtract 13 from 1,022 as quickly and accurately as p
Conditions Studied
Interventions
- DRUG placebo
- DRUG Oxytocin
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2012-06 |
| Est. Completion | 2017-06 |
| Phase | NA |
What the finished NCT01576874 record still lists
NCT01576874 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 185-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Nicotine Dependence appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01576874 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT01576874 about?
NCT01576874 is a clinical study titled "The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking". The purpose of the overall parent study is to determine the impact of gender and hormones (estradiol, progesterone, testosterone and cortisol) on responses to stress and smoking cues presented in daily, "real-world" cue presentations compared to a final cue session in a lab. In addition, in the port...
What is the current status of trial NCT01576874?
This trial is currently completed. It is a NA study. The enrollment target is 144 participants. The study started on 2012-06. Estimated completion is 2017-06.
What conditions does trial NCT01576874 study?
This clinical trial studies the following conditions: Nicotine Dependence.
What interventions are being tested in trial NCT01576874?
The interventions under investigation include: placebo (DRUG), Oxytocin (DRUG).
Who is sponsoring clinical trial NCT01576874?
This trial is sponsored by Kevin Gray, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01576874 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Nicotine 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 NCT01576874's enrollment target sits among peer trials
144 23rd of 67 higher than 45 of 67 other Nicotine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nicotine 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
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