Nicotine DependencePhase 2NCT01811225
Smoking, Sex Hormones, and Pregnancy
A Phase 2 study testing Low-dose Progesterone and High-dose Progesterone in people with Nicotine Dependence and Contraception, run by University of Minnesota at 1 site in United States.
Trial summary
The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Contraception
- What is being tested?
- Low-dose Progesterone and High-dose Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2017
- Phase
- Phase 2
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- currently taking oral contraceptives
- English fluency
- Ability to provide informed consent
Who cannot join
- use of progestin only contraceptive
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence
Read the detailed description
The sample population will consist of oral contraceptive users, both "low" and "high" dose levels of exogenous progesterone with a consistent dose of exogenous estrogen. Participants will complete data collection procedures including providing saliva (cortisol to measure stress), urine (cotinine and 3-Hydroxycotinine to measure nicotine exposure), and blood (progesterone, allopregnanolone, and estradiol) samples, as well as ecological momentary assessments (EMA) daily for seven-days. Participants will also complete a 3-hour smoking topography lab session after overnight abstinence and a 4.5-hour nicotine nasal spray lab session after a 14-hour abstinence. These sessions will contain a nicotine challenge via smoking a cigarette or nasal spray with timed-series physiological, subjective, and behavioral responses.
- Conditions
- Nicotine Dependence, Contraception
- Being tested
- Low-dose Progesterone, High-dose Progesterone
- 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.
Low-dose ProgesteroneDrug
The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).
High-dose ProgesteroneDrug
The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Contraceptive, then High-Dose | Experimental | Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given Tri-Sprintec and generic Prometrium.
Participants in this arm will begin with the "low" dose progesterone, which is seven days of placebo Tri-sprintec + placebo generic Prometrium twice daily (7AM and 7PM). Then participants in this arm will move to the "high" dose progesterone, which is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice daily (7AM and 7PM). Receives: Drug: Low-dose Progesterone; Drug: High-dose Progesterone |
| High-Dose Contraceptive, then Low-Dose | Experimental | Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given Tri-Sprintec and generic Prometrium.
Participants in this arm will begin with the "high" progesterone dose, which is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice daily (7AM and 7PM). Then participants in this arm will move to the "low" dose progesterone, which is seven days of placebo Tri-sprintec + placebo generic Prometrium twice daily (7AM and 7PM). Receives: Drug: Low-dose Progesterone; Drug: High-dose Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Smoking Urges
Questionnaire on Smoking Urges-Brief (QSU-Brief): This ten-item version of the original form (QSU) was developed by Tiffany and Drobes and has an excellent level of reliability (α = .97). Total QSU-Brief. Scores can average between 1-7. A higher scores means more urges.
Measured: after overnight abstinence on day 8
Secondary outcomes (2)
Change in Positive and Negative Affect Scale Following Overnight Abstinence
Positive and Negative Affect Scale (PANAS): Participants rate 20 words associated with positive or negative affect using a five-point Likert-type scale. This scale has been shown to have high internal consistency. Positive PANAS scores can range from 10-50. A higher score means greater positive affect. Negative PANAS score can range from 10-50. A higher score means greater negative affect.
Measured: after overnight abstinence on day 8
Change in Cohen Perceived Stress Scale
Cohen Perceived Stress Scale (PSS): This ten-item questionnaire has been validated in a variety of populations including pregnant and postpartum women. It uses five-items to assess ten questions resulting in two factors negative feelings and inability to handle stress. It has high internal reliability (alpha = 0.75). Score range from 0-56. A higher score means more perceived stress.
Measured: after overnight abstinence on day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionJun 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon S. Allen, M.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811225
- Sponsor's protocol ID
- 2012NTLS018
- Status last verified
- Oct 2020
- First submitted
- 21 Feb 2013
- Last updated
- 13 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Allen S, Harrison K, Petersen A, Goodson J. Smoking-related symptomatology in pregnant smokers during ad libitum smoking and following overnight smoking abstinence. BMC Res Notes. 2019 Aug 1;12(1):473. doi: 10.1186/s13104-019-4503-x.
PubMed 31370907
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking, Sex Hormones, and Pregnancy
- ClinicalTrials.gov ID
- NCT01811225
- Acronym / sponsor ID
- 2012NTLS018
- Conditions
- Nicotine Dependence, Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Posted 13 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence
Detailed description
The sample population will consist of oral contraceptive users, both "low" and "high" dose levels of exogenous progesterone with a consistent dose of exogenous estrogen. Participants will complete data collection procedures including providing saliva (cortisol to measure stress), urine (cotinine and 3-Hydroxycotinine to measure nicotine exposure), and blood (progesterone, allopregnanolone, and estradiol) samples, as well as ecological momentary assessments (EMA) daily for seven-days. Participants will also complete a 3-hour smoking topography lab session after overnight abstinence and a 4.5-hour nicotine nasal spray lab session after a 14-hour abstinence. These sessions will contain a nicotine challenge via smoking a cigarette or nasal spray with timed-series physiological, subjective, and behavioral responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Contraceptive, then High-Dose | Experimental | Drug: Low-dose Progesterone, Drug: High-dose ProgesteroneFemales, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given Tri-Sprintec and generic Prometrium. Participants in this arm will begin with the "low" dose progesterone, which is seven days of placebo Tri-sprintec + placebo generic Prometrium twice daily (7AM and 7PM). Then participants in this arm will move to the "high" dose progesterone, which is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice daily (7AM and 7PM). |
| High-Dose Contraceptive, then Low-Dose | Experimental | Drug: Low-dose Progesterone, Drug: High-dose ProgesteroneFemales, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given Tri-Sprintec and generic Prometrium. Participants in this arm will begin with the "high" progesterone dose, which is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice daily (7AM and 7PM). Then participants in this arm will move to the "low" dose progesterone, which is seven days of placebo Tri-sprintec + placebo generic Prometrium twice daily (7AM and 7PM). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- currently taking oral contraceptives
- English fluency
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- use of progestin only contraceptive
- pregnancy
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 |
|---|---|---|
| Low-dose ProgesteroneThe "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM). | Drug | High-Dose Contraceptive, then Low-Dose, Low-Dose Contraceptive, then High-Dose |
| High-dose ProgesteroneThe "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM). | Drug | High-Dose Contraceptive, then Low-Dose, Low-Dose Contraceptive, then High-Dose |
Primary outcome
Change in Smoking Urges
Time frame: after overnight abstinence on day 8
Questionnaire on Smoking Urges-Brief (QSU-Brief): This ten-item version of the original form (QSU) was developed by Tiffany and Drobes and has an excellent level of reliability (α = .97). Total QSU-Brief. Scores can average between 1-7. A higher scores means more urges.
2 secondary outcomes
Change in Positive and Negative Affect Scale Following Overnight Abstinence
Time frame: after overnight abstinence on day 8
Change in Cohen Perceived Stress Scale
Time frame: after overnight abstinence on day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31370907Allen S, Harrison K, Petersen A, Goodson J. Smoking-related symptomatology in pregnant smokers during ad libitum smoking and following overnight smoking abstinence. BMC Res Notes. 2019 Aug 1;12(1):473. doi: 10.1186/s13104-019-4503-x.
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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.
Sharon S. Allen, M.D. principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose Progesterone and High-dose Progesterone in people with Nicotine Dependence and Contraception, 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 3 inclusion and 2 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 13 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2020). 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?
Change in Smoking Urges (time frame: after overnight abstinence on day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01811225, which also lists 1 linked publication.
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 13 Nov 2020.