CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 216 enrolled
Drug / intervention
Progesterone +2 moredrug
Likely dose
Progesterone 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01744574
NCT01744574N/ACompleted

Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation

University of Minnesota·interventional·Posted Dec 6, 2012·Updated Jul 12, 2019

In Brief

A clinical study evaluating Placebo, Progesterone, and 1 other intervention for Tobacco Cessation. Completed, enrolled 216 participants across 1 site.

Detailed Summary

Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in Project I we are proposing a double-blind randomized controlled trial to assess the role of exogenous progesterone on impulsivity and smoking cessation in a sample of males and females who are motivated to quit smoking.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2012
Enrollment StartDec 1, 2012
Primary CompletionJul 27, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.6 years ago

Interventions

Placeboother

Placebo - subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.

Progesteronedrug

The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.

Smoking Cessation Behavioral Counselingother

Subjects will receive weekly smoking cessation behavioral counseling.