Progesterone and Brain Imaging Study

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Progesterone

Criteria

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 nicotine, alcohol and marijuana, as per SCID interview

• Substance use disorders within the previous 2 years, excepting nicotine, as per SCID interview

• Regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products;

• Known allergy to progesterone or peanuts (vehicle for micronized progesterone).