Smoking, Sex Hormones, and Pregnancy

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Nicotine Dependence; Contraception

Treatments: Drug: High-dose Progesterone; Drug: Low-dose Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT01811225

2012NTLS018

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• currently taking oral contraceptives
• English fluency
• Ability to provide informed consent

Exclusion criteria

• use of progestin only contraceptive
• pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Low-Dose Contraceptive, then High-Dose

Experimental group

Description:

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).

Treatment:

Drug: High-dose Progesterone

Drug: Low-dose Progesterone

High-Dose Contraceptive, then Low-Dose

Experimental group

Description:

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).

Treatment:

Drug: High-dose Progesterone

Drug: Low-dose Progesterone