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Completed

NCT Number: NCT01811225

Smoking, Sex Hormones, and Pregnancy

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

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Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Contraception Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • use of progestin only contraceptive
  • pregnancy

Treatment and study plan

Low-dose Progesterone

Drug

The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).

High-dose Progesterone

Drug

The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Positive and Negative Affect Scale Following Overnight Abstinence

    Time frame: after overnight abstinence on day 8

    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.

  2. Change in Cohen Perceived Stress Scale

    Time frame: after overnight abstinence on day 8

    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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 14, 2013
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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