Progesterone Augmentation of Nicotine Replacement Therapy Study

Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:18 - 45
Start Date:April 7, 2016
End Date:September 1, 2018
Contact:Marla Genova, MA

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This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of
50 women who smoke and have regular menstrual cycles will be randomized to either
progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks.
TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued at
the end of Week 8. All participants will also be provided behavioral treatment for smoking
cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a one-week
period (Week 1) during the mid luteal phase, within a week before menses and the target quit
date will be set for the 5 (+/-2) days after onset of menses. Participants will have
post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self- report of
smoking abstinence, biochemically verified smoking abstinence, measures of cigarette craving
and nicotine withdrawal, and measures of response inhibition.

This study seeks to determine if modifying the hormonal milieu of the menstrual cycle,
through administration of exogenous progesterone, will improve the effectiveness of
treatments for smoking cessation in women. Progesterone, a gonadal hormone, is used
clinically for treatment of endometrial hyperplasia, amenorrhea, dysfunctional uterine
bleeding, and for assisted reproduction in women. Progesterone also shows promise for the
treatment of multiple central nervous system disorders including cocaine addiction, seizure
disorder, and traumatic brain injury. As the next step, the investigators seek to determine
if progesterone augments standard smoking cessation treatments (e.g., NRT) in regularly
cycling women. The investigators hypothesize that co-treatment with progesterone, compared to
placebo, will enhance the effectiveness NRT for smoking cessation. To test this hypothesis,
the investigators propose an 8-week, double-blind, placebo-controlled clinical trial, which
will randomize 50 smokers using a 1:1 assignment ratio to 400 mg/day progesterone or placebo.
Consistent with the Clinical Practice Guidelines, all participants will also receive
transdermal nicotine patch (TNP) plus brief counseling for smoking cessation during the study

Specific Aim #1: To determine if progesterone +TNP is superior to placebo +TNP for prolonged
and 7-day point prevalence of smoking abstinence rates at the end of 8 weeks of treatment and
at 1 and 3 month follow-up time points. The investigators will also evaluate the safety and
tolerability of progesterone treatment, compared to placebo. Our co-primary outcome measures
will be 7-day point prevalence of smoking abstinence and breath CO at the end of treatment
and 1- and 3-months after the end of the trial. Specific Aim #2: To determine if progesterone
+ TNP treatment, compared to placebo + TNP, improves response inhibitory function, as
assessed by the Stroop, The Go/No Go task, and the Digit Symbol Task. Specific Aim # 3: To
determine if progesterone + TNP treatment, compared to placebo + TNP, leads to a greater
reduction in cigarette craving and nicotine withdrawal symptoms, as assessed by the
Questionnaire on Smoking Urges-Brief (QSU-B) and the Minnesota Nicotine Withdrawal Scale
(MNWS), respectively. Specific Aim #4: To evaluate with affective changes, as shown on the
Positive and Negative Affect Schedule, mediates the effects of progesterone on smoking

Inclusion Criteria:

- Aged 18 - 45

- Smoking at least 5 cigarettes/ day for at least one year

- Regular menstrual cycles every 24-36 days for the previous 6 months

- Motivated to quit smoking (i.e., a rating of at least "7 "on a 10-point scale where 1
is not at all motivated and 10 is extremely motivated)

- In good health

- Using an acceptable, non-hormonal birth control

Exclusion Criteria:

A history of major medical or psychological illnesses including:

- liver disease

- heart disease

- diabetes

- malignancy including history of breast cancer

- deep vein thrombosis

- blood coagulation problems including a history or family history of thrombophilia

- liver failure

- cervical intra-epithelial lesions III or greater that are untreated

- other medical conditions that the physician investigators deems will make study
participation unsafe for the subject

- current or past history bipolar disorder or schizophrenia

- current diagnosis of major depression

- panic disorder or post-traumatic stress disorder

- active drug (non-nicotine) and/or alcohol dependence

- currently undergoing treatment with another pharmacological agent for smoking

- regular use of sedating medications including sleeping aids, antihistamines, and
others use of nicotine from cigars, pipes, chewing tobacco

- pregnant

- breast- feeding or intending to become pregnant within 6 months

- allergy to nicotine patch or progesterone

- allergy to peanuts or other nuts.
We found this trial at
New Haven, Connecticut 06510
Principal Investigator: Kimberly A Yonkers, M.D.
Phone: 203-764-8124
New Haven, CT
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