Trial Outcomes & Findings for The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking (NCT NCT01576874)

Last Updated: 2020-07-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

144 participants

Primary outcome timeframe

Immediately after the conclusion of the TSST

Results posted on

2020-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Oxytocin Participants will be administered 40 IUs of oxytocin nasal spray at one study visit. Oxytocin: 40 IUs of oxytocin administered intranasally one time	Placebo Participants will be administered 40 IUs of placebo nasal spray at one study visit. placebo: placebo administered intranasally one time
Overall Study STARTED	72	72
Overall Study COMPLETED	72	72
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin n=72 Participants Participants will be administered 40 IUs of oxytocin nasal spray at one study visit. Oxytocin: 40 IUs of oxytocin administered intranasally one time	Placebo n=72 Participants Participants will be administered 40 IUs of placebo nasal spray at one study visit. placebo: placebo administered intranasally one time	Total n=144 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	72 Participants n=5 Participants	72 Participants n=7 Participants	144 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.4 years STANDARD_DEVIATION 7.1 • n=5 Participants	31.6 years STANDARD_DEVIATION 7.7 • n=7 Participants	31 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	46 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	40 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after the conclusion of the TSST

Outcome measures

Outcome measures
Measure	Oxytocin n=72 Participants Participants will be administered 40 IUs of oxytocin nasal spray at one study visit. Oxytocin: 40 IUs of oxytocin administered intranasally one time	Placebo n=72 Participants Participants will be administered 40 IUs of placebo nasal spray at one study visit. placebo: placebo administered intranasally one time
Craving Response to Trier Social Stress Task	16.18 units on a scale Standard Deviation 4.78	16.69 units on a scale Standard Deviation 4.78

SECONDARY outcome

Timeframe: Immediately after the conclusion of the TSST

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

Outcome measures

Outcome measures
Measure	Oxytocin n=72 Participants Participants will be administered 40 IUs of oxytocin nasal spray at one study visit. Oxytocin: 40 IUs of oxytocin administered intranasally one time	Placebo n=72 Participants Participants will be administered 40 IUs of placebo nasal spray at one study visit. placebo: placebo administered intranasally one time
Stress Response to Trier Social Stress Task	2.81 units on a scale Standard Deviation 1.43	2.57 units on a scale Standard Deviation 1.23

SECONDARY outcome

Timeframe: Immediately following the Trier Social Stress Task

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

Outcome measures

Outcome measures
Measure	Oxytocin n=72 Participants Participants will be administered 40 IUs of oxytocin nasal spray at one study visit. Oxytocin: 40 IUs of oxytocin administered intranasally one time	Placebo n=72 Participants Participants will be administered 40 IUs of placebo nasal spray at one study visit. placebo: placebo administered intranasally one time
Cortisol Response to Trier Social Stress Task	0.25 micrograms per deciliter Standard Deviation 0.13	0.25 micrograms per deciliter Standard Deviation 0.14

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kevin M. Gray, M.D.

Medical University of South Carolina

Phone: 843-792-6330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place