CompletedPhase 4

Progesterone and Brain Imaging Study

United States81 participantsStarted 2010-11

Plain-language summary

Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female and male smokers, aged 18 to 50 years; * History of smoking greater than or equal to 10 cigarettes daily for the past year, as per self-report (periods of smoking abstinence within the last year will be exclusionary at PI discretion); * Not seeking treatment at the time of the study for nicotine dependence; * Have a Fagerstrom Test for Nicotine Dependence (FTND) score of at least 3 and a Carbon Monoxide (CO) level greater than or equal to 11 ppm; * Clean urine drug screen (marijuana is permissible); * In good health as verified by medical history; * For women, not pregnant as determined by pregnancy screening, nor breast feeding. Exclusion Criteria: * History of major medical illness: including liver diseases, abnormal vaginal bleeding, suspected or known malignancy; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; history of stroke or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study; * Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent (within previous year) psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, generalized anxiety disorder, post-traumatic stress disorder and panic disorder; * Lifetime history of schizophrenia or other psychotic disorder; * Lifetime substance dependence disorder, excepting…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])

Timeframe: Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.

GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC])

Timeframe: Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.

Trial details

NCT IDNCT01954966

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12

Results submitted2022-04-26

View on ClinicalTrials.gov More Nicotine Dependence trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])

Timeframe: Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.

GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC])

Timeframe: Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.