Phase 4
Completed N=64
Progesterone Augmentation of Nicotine Replacement Therapy Study
Source: ClinicalTrials.gov NCT02685072 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: 7-day Point Prevalence of Smoking Abstinence — 8; 11; 25; 20 Participants — p=0.3253
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point Prevalence of Smoking Abstinence |
8; 11; 25; 20 | 0.3253 |
| SECONDARY Carbon Monoxide <10 Ppm |
10; 10; 23; 21 | 0.8661 |
| SECONDARY Carbon Monoxide <10 Ppm |
10; 10; 23; 21 | 0.8661 |
| SECONDARY Carbon Monoxide <10 Ppm |
10; 10; 23; 21 | 0.8661 |
| SECONDARY Change in Stroop Measure of Inhibitory Function |
4.1; -5.0 | 0.31 |
| SECONDARY Change in Go/No Go Task Measure of Inhibitory Function |
0.36; 0.50 | 0.7910 |
| SECONDARY Change in Digit Symbol Task Measure of Inhibitory Function |
-3.95; 5.32 | 0.0065 sig |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Total Score |
24.8; 27.7; 11.3; 11.1 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Total Score |
24.8; 27.7; 11.3; 11.1 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Total Score |
24.8; 27.7; 11.3; 11.1 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Total Score |
24.8; 27.7; 11.3; 11.1 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Total Score |
24.8; 27.7; 11.3; 11.1 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Total Score |
24.8; 27.7; 11.3; 11.1 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Total Score |
24.8; 27.7; 11.3; 11.1 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Total Score |
24.8; 27.7; 11.3; 11.1 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Total Score |
24.8; 27.7; 11.3; 11.1 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Total Score |
24.8; 27.7; 11.3; 11.1 | — |
| SECONDARY Prolonged Abstinence Post Trial |
4; 5; 29; 26 | .6449 |
| SECONDARY Prolonged Abstinence Follow up |
4; 5; 29; 26 | 0.6449 |
Eligibility Criteria
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 cessation
- 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.
Data sourced from ClinicalTrials.gov (NCT02685072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.