Nicotine DependenceSCOR-IIINCT01576874
The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking
A study testing Oxytocin in people with Nicotine Dependence, run by Kevin Gray, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Females and males age 18 - 45 who smoke at least an average of 5 cigarettes per day for at least past 6 months
- 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
- Participants must submit a carbon monoxide sample of ≥ 5 ppm at their screening visit
Who cannot join
- Any serious or unstable medical or psychiatric disorder that may, in the judgment of the study physician, interfere with study completion
- Participants must not meet criteria for PTSD
- Any medication (e.g., propranolol) that may interfere with psychophysiological (e.g., heart rate) monitoring
- Current substance dependence other than nicotine and caffeine use, in the past month
- Use of other tobacco products
- 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
- Males must not be status post orchiectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the detailed description
Despite considerable advances in treatment development, cigarette smoking remains the leading cause of preventable death in the United States, and most smokers engaged in treatment are unsuccessful in quitting. The burden of illness is disproportionately borne by female smokers, who are less responsive to cessation interventions than males. The relationships between stress, craving, and smoking behavior are recognized as key factors underlying gender differences in nicotine dependence, but must be better understood and characterized to yield avenues for interventions addressing this critical health disparity.
In prior and ongoing SCOR studies, our research team has demonstrated gender and menstrual cycle/sex hormone influences on reactivity to laboratory-presented cues. Building from these laboratory findings, we propose taking two important next steps: (1) evaluating the experience of craving in the "real world" natural environment of female and male smokers, and (2) examining the impact of a safe and novel pharmacological intervention (oxytocin) on stress reactivity in female and male smokers.
If, as hypothesized, gender, sex hormones, and oxytocin administration influence the relationships between stress, craving, and smoking behavior, the findings could substantially address a key gender-related health disparity. Such knowledge could also inform the development of gender-specific interventions to enhance female smokers' response to cessation treatments. Therefore, the knowledge to be gained from the proposed study may yield significant public health benefits.
- Conditions
- Nicotine Dependence
- Being tested
- Oxytocin, placebo
- Keywords
- nicotine dependence, hormones
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon
40 IUs of oxytocin administered intranasally one time
placeboDrug
placebo administered intranasally one time
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | Participants will be administered 40 IUs of oxytocin nasal spray at one study visit. Receives: Drug: Oxytocin |
| placebo | Placebo comparator | Participants will be administered 40 IUs of placebo nasal spray at one study visit. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving Response to Trier Social Stress Task
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.
Measured: Immediately after the conclusion of the TSST
Secondary outcomes (2)
Stress Response to Trier Social Stress Task
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
Measured: Immediately after the conclusion of the TSST
Cortisol Response to Trier Social Stress Task
Cortisol measured immediately following the Trier Social Stress Task, to evaluate physiological stress response.
Measured: Immediately following the Trier Social Stress Task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin Gray, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Kevin Gray, MD, Medical University of South Carolina
- Investigators
- Michael Saladin, PhD, Principal investigator, Medical University of South CarolinaKevin M Gray, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576874
- Sponsor's protocol ID
- Pro00016931
- Other IDs
- P50DA016511
- Acronym
- SCOR-III
- Status last verified
- Jun 2020
- First submitted
- 10 Apr 2012
- Last updated
- 1 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking
- ClinicalTrials.gov ID
- NCT01576874
- Acronym / sponsor ID
- SCOR-III / Pro00016931
- Conditions
- Nicotine Dependence
- Keywords
- nicotine dependence, hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Kevin Gray, MDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2012
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Posted 17 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite considerable advances in treatment development, cigarette smoking remains the leading cause of preventable death in the United States, and most smokers engaged in treatment are unsuccessful in quitting. The burden of illness is disproportionately borne by female smokers, who are less responsive to cessation interventions than males. The relationships between stress, craving, and smoking behavior are recognized as key factors underlying gender differences in nicotine dependence, but must be better understood and characterized to yield avenues for interventions addressing this critical health disparity.
In prior and ongoing SCOR studies, our research team has demonstrated gender and menstrual cycle/sex hormone influences on reactivity to laboratory-presented cues. Building from these laboratory findings, we propose taking two important next steps: (1) evaluating the experience of craving in the "real world" natural environment of female and male smokers, and (2) examining the impact of a safe and novel pharmacological intervention (oxytocin) on stress reactivity in female and male smokers.
If, as hypothesized, gender, sex hormones, and oxytocin administration influence the relationships between stress, craving, and smoking behavior, the findings could substantially address a key gender-related health disparity. Such knowledge could also inform the development of gender-specific interventions to enhance female smokers' response to cessation treatments. Therefore, the knowledge to be gained from the proposed study may yield significant public health benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: OxytocinParticipants will be administered 40 IUs of oxytocin nasal spray at one study visit. |
| placebo | Placebo comparator | Drug: placeboParticipants will be administered 40 IUs of placebo nasal spray at one study visit. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females and males age 18 - 45 who smoke at least an average of 5 cigarettes per day for at least past 6 months
- 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
- Participants must submit a carbon monoxide sample of ≥ 5 ppm at their screening visit
Key exclusion criteria (7 listed)
- Any serious or unstable medical or psychiatric disorder that may, in the judgment of the study physician, interfere with study completion
- Participants must not meet criteria for PTSD
- Any medication (e.g., propranolol) that may interfere with psychophysiological (e.g., heart rate) monitoring
- Current substance dependence other than nicotine and caffeine use, in the past month
- Use of other tobacco products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: syntocinon40 IUs of oxytocin administered intranasally one time | Drug | oxytocin |
| placeboplacebo administered intranasally one time | Drug | placebo |
Primary outcome
Craving Response to Trier Social Stress Task
Time frame: 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 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.
2 secondary outcomes
Stress Response to Trier Social Stress Task
Time frame: Immediately after the conclusion of the TSST
Cortisol Response to Trier Social Stress Task
Time frame: Immediately following the Trier Social Stress Task
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Saladin, PhD principal investigator
Medical University of South Carolina
Kevin M Gray, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Nicotine Dependence, run by Kevin Gray, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving Response to Trier Social Stress Task (time frame: Immediately after the conclusion of the TSST). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.