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Trial · Interventional

CompletedNot applicableResults postedRegistry data

The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking

Short name SCOR-III

NCTNCT01576874 (opens ClinicalTrials.gov in a new tab)Other idPro00016931Other idP50DA016511
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
144 participants (actual)
Sponsor
Kevin Gray, MD · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jun 2012
Primary completion
May 2017
Completion
Jun 2017
First posted
13 Apr 2012 (estimated)
Last update posted
1 Jul 2020
Conditions
Nicotine Dependence

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015201620172018
  1. N/A

    SCOR-III

    NCT01576874

    Jun 2012 to Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • placeboDrug

Arms2

  • Experimental

    oxytocin

    Participants will be administered 40 IUs of oxytocin nasal spray at one study visit.

  • Placebo comparator

    placebo

    Participants will be administered 40 IUs of placebo nasal spray at one study visit.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Craving Response to Trier Social Stress Task

    Time frame · Immediately after the conclusion of the TSST

    Registry description

    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 possible. The mental math recitation continues for 5 min, and at its conclusion, the spokesperson instructs the participant to stop and be seated, and the audience leaves the room. The total time for the TSST is 15 min. The Craving Questionnaire (Carter \& Tiffany, 2001) is the sum of 4 items, each rated 1-5 on a Likert scale, with total score ranging 4-20, and higher scores indicating higher craving.

Secondary outcomes(2)

  1. Stress Response to Trier Social Stress Task

    Time frame · Immediately after the conclusion of the TSST

    Registry description

    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 possible. The mental math recitation continues for 5 min, and at its conclusion, the spokesperson instructs the participant to stop and be seated, and the audience leaves the room. The total time for the TSST is 15 min. The single stress item is derived from the CREMA Mood/Stress Assessment (Warthen \& Tiffany, 2009), asking how stressed the participant felt at that time, on a 5-point Likert scale, ranging 1-5 with higher score indicating feeling more stressed

  2. Cortisol Response to Trier Social Stress Task

    Time frame · Immediately following the Trier Social Stress Task

    Registry description

    Cortisol measured immediately following the Trier Social Stress Task, to evaluate physiological stress response.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Immediately after the conclusion of the TSST

Craving Response to Trier Social Stress Task

GroupValue (units on a scale)Spread
Oxytocin16.184.78
Placebo16.694.78
Secondary and other outcome results(2)
Secondary outcomeMean· Immediately after the conclusion of the TSST

Stress Response to Trier Social Stress Task

GroupValue (units on a scale)Spread
Oxytocin2.811.43
Placebo2.571.23
Secondary outcomeMean· Immediately following the Trier Social Stress Task

Cortisol Response to Trier Social Stress Task

GroupValue (micrograms per deciliter)Spread
Oxytocin0.250.13
Placebo0.250.14

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinParticipants will be administered 40 IUs of oxytocin nasal spray at one study visit. Oxytocin: 40 IUs of oxytocin administered intranasally one time0 / 720 / 720 / 72
PlaceboParticipants will be administered 40 IUs of placebo nasal spray at one study visit. placebo: placebo administered intranasally one time0 / 720 / 720 / 72

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Females and males age 18 - 45 who smoke at least an average of 5 cigarettes per day for at least past 6 months 2. Females must be post menarche and pre-menopausal, have a regular menstrual cycle between 25 and 35 days, and, if recently pregnant, be at least three months post-delivery/breast feeding 3. Participants must submit a carbon monoxide sample of ≥ 5 ppm at their screening visit Exclusion Criteria: 1. Any serious or unstable medical or psychiatric disorder that may, in the judgment of the study physician, interfere with study completion 2. Participants must not meet criteria for PTSD 3. Any medication (e.g., propranolol) that may interfere with psychophysiological (e.g., heart rate) monitoring 4. Current substance dependence other than nicotine and caffeine use, in the past month 5. Use of other tobacco products 6. Females must not be pregnant, breast feeding, status post hysterectomy or bilateral oophorectomy, or taking birth control or hormone replacement medication that would affect the menstrual cycle 7. Males must not be status post orchiectomy

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