NCT02685072: PANS

Progesterone Augmentation of Nicotine Replacement Therapy Study

Completed Phase 4 Results posted Last updated 23 July 2019

What this trial tests

Phase 4 trial testing Progesterone (200 mgs BID) in Smoking Cessation in 64 participants. Completed in 12 March 2018.

Timeline

7 April 2016

Primary endpoint
18 December 2017

12 March 2018

Quick facts

Lead sponsor	Yale University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	7 April 2016
Primary completion	18 December 2017
Estimated completion	12 March 2018
Sites	1 location across United States

Drugs / interventions tested

• Progesterone (200 mgs BID) — full drug profile →
• Placebo

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Yale University

Who can join

Adults 18 to 45, female only, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

7-day Point Prevalence of Smoking Abstinence Primary · end of 8 weeks of treatment

The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days.

Group	Value	95% CI
TNP + Progesterone	8
TNP + Placebo	11
TNP + Progesterone	25
TNP + Placebo	20

Carbon Monoxide <10 Ppm Secondary · end of 8 weeks of treatment

Smoking abstinence measured by breath CO

Group	Value	95% CI
TNP + Progesterone	9
TNP + Placebo	8
TNP + Progesterone	24
TNP + Placebo	23

Carbon Monoxide <10 Ppm Secondary · 1 month follow up

Smoking abstinence measured by breath CO

Group	Value	95% CI
TNP + Progesterone	6
TNP + Placebo	7
TNP + Progesterone	27
TNP + Placebo	24

Carbon Monoxide <10 Ppm Secondary · 3 month follow up

Smoking abstinence measured by breath CO

Group	Value	95% CI
TNP + Progesterone	10
TNP + Placebo	10
TNP + Progesterone	23
TNP + Placebo	21

Change in Stroop Measure of Inhibitory Function Secondary · baseline and week 2

The Stroop test assesses cognitive processing. The Level 3 Stroop Throughput score incorporates both accuracy and speed. In Level 3 of the Stroop test, a series of words representing colors are shown in a font color that is incongruent with the word (e.g. RED would be shown in blue font). Users are asked to press a response key associated with the color of the font, not the written word. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of c

Group	Value	95% CI
TNP + Progesterone	4.1	± 24.7
TNP + Placebo	-5.0	± 28.7

Change in Go/No Go Task Measure of Inhibitory Function Secondary · baseline and week 2

Week 2 minus baseline. This task assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the "3". Go/No Go score is calculated as separation between the means of the signal and the noise distributions and is reported in standard deviation units, representing an overall indicator of performance since it accounts for correct responses and incorrect respo

Group	Value	95% CI
TNP + Progesterone	0.36	± 2.33
TNP + Placebo	0.50	± 1.45

Change in Digit Symbol Task Measure of Inhibitory Function Secondary · baseline and week 2

The Code Substitution Test (a computerized adaptation/variant of the Digit Symbol Substitution Test) is a test of psychomotor performance. The Code Substitution-Learning Throughput Score incorporates both accuracy and speed. During the learning phase of this test, users are continuously shown a row of 9 digits that are paired with a symbol (the pairings are constant). Users are presented with a series of individual pairings and are asked to press a response key to indicate if the pairing is correct or not. Quicker and more accurate responses lead to higher scores. The lowest possible score is

Group	Value	95% CI
TNP + Progesterone	-3.95	± 11.42
TNP + Placebo	5.32	± 11.59

Positive and Negative Affect Schedule (PANAS) Total Score Secondary · Baseline

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Positive Affect Score

Group	Value	95% CI
TNP + Progesterone	29.2	± 7.0
TNP + Placebo	25.6	± 7.7

Negative Affect Score

Group	Value	95% CI
TNP + Progesterone	11.9	± 2.1
TNP + Placebo	11.4	± 1.8

Positive and Negative Affect Schedule (PANAS) Total Score Secondary · Week 2

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Positive Affect Score

Group	Value	95% CI
TNP + Progesterone	27.0	± 7.1
TNP + Placebo	24.4	± 8.3

Negative Affect Score

Group	Value	95% CI
TNP + Progesterone	11.4	± 1.9
TNP + Placebo	11.3	± 1.7

Positive and Negative Affect Schedule (PANAS) Total Score Secondary · Week 3

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Positive Affect Score

Group	Value	95% CI
TNP + Progesterone	23.8	± 8.6
TNP + Placebo	27.0	± 8.0

Negative Affect Score

Group	Value	95% CI
TNP + Progesterone	11.6	± 2.1
TNP + Placebo	12.1	± 4.3

Positive and Negative Affect Schedule (PANAS) Total Score Secondary · Week 4

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Positive Affect Score

Group	Value	95% CI
TNP + Progesterone	28.0	± 7.4
TNP + Placebo	26.3	± 9.1

Negative Affect Score

Group	Value	95% CI
TNP + Progesterone	10.6	± 1.3
TNP + Placebo	11.6	± 3.3

Positive and Negative Affect Schedule (PANAS) Total Score Secondary · Week 5

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Positive Affect Score

Group	Value	95% CI
TNP + Progesterone	24.3	± 8.6
TNP + Placebo	27.9	± 9.1

Negative Affect Score

Group	Value	95% CI
TNP + Progesterone	10.7	± 1.0
TNP + Placebo	10.6	± 1.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TNP + Progesterone

Serious: 0/33 (0%)

Deaths: 0/33

TNP + Placebo

Serious: 0/31 (0%)

Deaths: 0/31

Other adverse events (7 terms — click to expand)

Reaction	System	TNP + Progesterone	TNP + Placebo
ER visit for unknown reason	General disorders	—	—
Ovarian cyst	Reproductive system and breast disorders	—	—
nausea, vomiting, diarrhea	Gastrointestinal disorders	—	—
wrist and back injury due to fall	Musculoskeletal and connective tissue disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Muscle pain	Musculoskeletal and connective tissue disorders	—	—
3 Menses in one month	Reproductive system and breast disorders	—	—

Data from ClinicalTrials.gov NCT02685072 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.