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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 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.

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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.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG Oxytocin

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2012-06
Est. Completion 2017-06
Phase NA

Sponsor

Kevin Gray, MD

2 total trials

What the Registry Record Tells You About NCT01576874

The ClinicalTrials.gov registry entry for NCT01576874 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 185-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (22% lower). The listed sponsor is Kevin Gray, MD, which has 2 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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