Smoking CessationNCT02087800
Smoking, Stress & Allopregnanolone Response
An observational study of Smoking Cessation, run by University of Minnesota at 1 site in United States.
Trial summary
This study aims to characterize the effect of smoking on stress-induced allopregnanolone (ALLO) response in women by menstrual phase. The investigators hypothesize that women who smoke will have a blunted ALLO response to stress. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- F phase lab session and L phase lab session
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between the ages of 18 and 40 who either smoke or do not smoke.
Who may be able to join
- Female between the ages of 18-40 years old
- Stable physical/mental health,
- Self-report of regular menstrual cycles,
- Self-report of either smoking either current or never smoking,
- English fluency,
- Ability to provide informed consent
Who cannot join
- Self-report of current use of illicit drugs, other tobacco products, nicotine, or smoking cessation medications,
- Current or recent pregnancy or breastfeeding,
- Current or recent use of exogenous hormones (including birth control pills),
- Current or recent use of psychotropic medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Tobacco Research Program
Minneapolis, Minnesota, 55455
About this study
Official title: Effect of Smoking on Stress-Induced Allopregnanolone Response in Women by Menstrual Phase
This study aims to characterize the effect of smoking on stress-induced allopregnanolone (ALLO) response in women by menstrual phase. The investigators hypothesize that women who smoke will have a blunted ALLO response to stress.
Read the detailed description
Cigarette smoking persists as the leading cause of preventable morbidity and mortality. Thus, finding ways to maximize quitting behavior is critical. Women have a more difficult time achieving smoking abstinence than men. The risk for smoking relapse appears to vary by menstrual phase such that the follicular phase is associated with greater risk compared to the luteal phase. Women are also more likely to smoke in response to stressful stimuli than men. Allopregnanolone (ALLO) is a stress-reducing neuroactive steroid that is primarily metabolized from the sex hormone progesterone and, therefore, varies by menstrual phase in women. Recent preclinical literature has indicated that ALLO may protect against drug abuse behaviors. Unfortunately, ALLO remains largely unexplored in clinical samples containing women.
In this study we aim to characterize the effect of smoking on stress-induced ALLO response in women by menstrual phase. To achieve this goal, we will recruit a sample of premenopausal women who smoke (n=30) and do not smoke (n=30) to participate in a controlled cross-over study. All participants will complete two four-hour lab sessions timed to occur in the Follicular (F; low ALLO) and Luteal (L; high ALLO) menstrual phases. Each lab session will contain an acute stressor along with a timed series of assessments including blood samples (for ALLO measurement) and self-report of mood and perceived stress.
- Conditions
- Smoking Cessation
- Being tested
- F phase lab session, L phase lab session
- Keywords
- smoking cessation, smoking abstinence, allopregnanolone
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F phase lab sessionBehavioural
F phase sessions will occur three to seven days post the onset of menses. It will include blood draws, an acute stressor and completion of questionnaires.
L phase lab sessionBehavioural
L phase sessions will occur six to ten days prior to the onset of the next expected menses. It will include blood draws, an acute stressor and completion of questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| F Phase Lab session | Potential participants will complete an interview over the phone, followed by an in clinic office visit, to assess eligibility. Those who meet eligibility criteria will be invited to attend two four-hour lab sessions. Lab sessions will occur in the F (F phase lab session) and L phases (L phase lab session) of menses. In this arm, the F phase lab session will be first. Followed by the L phase lab session. Receives: Behavioral: F phase lab session; Behavioral: L phase lab session | |
| L Phase Lab Session | Potential participants will complete an interview over the phone, followed by an in clinic office visit, to assess eligibility. Those who meet eligibility criteria will be invited to attend two four-hour lab sessions. Lab sessions will occur in the F (F phase lab session) and L phases (L phase lab session) of menses. In this arm, the L phase lab session will be first. Followed by the F phase lab session. Receives: Behavioral: F phase lab session; Behavioral: L phase lab session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in allopregnanolone levels
The change in ALLO after delivery of the acute stressor will be analyzed.
Measured: 6 weeks
Secondary outcomes (2)
Change in mood
We will analyze ALLO levels and mood to see if there is an association between the two.
Measured: 6 weeks
Change in stress level
We will analyze ALLO levels and perceived stress level to see if there is an association and whether stress changes as ALLO levels change.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Allen, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087800
- Sponsor's protocol ID
- 2013NTLS120
- Status last verified
- Aug 2015
- First submitted
- 12 Mar 2014
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking on Stress-Induced Allopregnanolone Response in Women by Menstrual Phase
- ClinicalTrials.gov ID
- NCT02087800
- Acronym / sponsor ID
- 2013NTLS120
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, smoking abstinence, allopregnanolone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to characterize the effect of smoking on stress-induced allopregnanolone (ALLO) response in women by menstrual phase. The investigators hypothesize that women who smoke will have a blunted ALLO response to stress.
Detailed description
Cigarette smoking persists as the leading cause of preventable morbidity and mortality. Thus, finding ways to maximize quitting behavior is critical. Women have a more difficult time achieving smoking abstinence than men. The risk for smoking relapse appears to vary by menstrual phase such that the follicular phase is associated with greater risk compared to the luteal phase. Women are also more likely to smoke in response to stressful stimuli than men. Allopregnanolone (ALLO) is a stress-reducing neuroactive steroid that is primarily metabolized from the sex hormone progesterone and, therefore, varies by menstrual phase in women. Recent preclinical literature has indicated that ALLO may protect against drug abuse behaviors. Unfortunately, ALLO remains largely unexplored in clinical samples containing women.
In this study we aim to characterize the effect of smoking on stress-induced ALLO response in women by menstrual phase. To achieve this goal, we will recruit a sample of premenopausal women who smoke (n=30) and do not smoke (n=30) to participate in a controlled cross-over study. All participants will complete two four-hour lab sessions timed to occur in the Follicular (F; low ALLO) and Luteal (L; high ALLO) menstrual phases. Each lab session will contain an acute stressor along with a timed series of assessments including blood samples (for ALLO measurement) and self-report of mood and perceived stress.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F Phase Lab session | – | Behavioral: F phase lab session, Behavioral: L phase lab sessionPotential participants will complete an interview over the phone, followed by an in clinic office visit, to assess eligibility. Those who meet eligibility criteria will be invited to attend two four-hour lab sessions. Lab sessions will occur in the F (F phase lab session) and L phases (L phase lab session) of menses. In this arm, the F phase lab session will be first. Followed by the L phase lab session. |
| L Phase Lab Session | – | Behavioral: F phase lab session, Behavioral: L phase lab sessionPotential participants will complete an interview over the phone, followed by an in clinic office visit, to assess eligibility. Those who meet eligibility criteria will be invited to attend two four-hour lab sessions. Lab sessions will occur in the F (F phase lab session) and L phases (L phase lab session) of menses. In this arm, the L phase lab session will be first. Followed by the F phase lab session. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between the ages of 18 and 40 who either smoke or do not smoke.
Key inclusion criteria (6 listed)
- Female between the ages of 18-40 years old
- Stable physical/mental health,
- Self-report of regular menstrual cycles,
- Self-report of either smoking either current or never smoking,
- English fluency,
Key exclusion criteria (4 listed)
- Self-report of current use of illicit drugs, other tobacco products, nicotine, or smoking cessation medications,
- Current or recent pregnancy or breastfeeding,
- Current or recent use of exogenous hormones (including birth control pills),
- Current or recent use of psychotropic medications.
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 |
|---|---|---|
| F phase lab sessionF phase sessions will occur three to seven days post the onset of menses. It will include blood draws, an acute stressor and completion of questionnaires. | Behavioural | F Phase Lab session, L Phase Lab Session |
| L phase lab sessionL phase sessions will occur six to ten days prior to the onset of the next expected menses. It will include blood draws, an acute stressor and completion of questionnaires. | Behavioural | F Phase Lab session, L Phase Lab Session |
Primary outcome
Change in allopregnanolone levels
Time frame: 6 weeks
The change in ALLO after delivery of the acute stressor will be analyzed.
2 secondary outcomes
Change in mood
Time frame: 6 weeks
Change in stress level
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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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.
Alicia Allen, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by University of Minnesota 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 6 inclusion and 4 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 30 Nov 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in allopregnanolone levels (time frame: 6 weeks). 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 30 Nov 2015.