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Sex Differences, Hormones & Smoking Cessation

NCT01744574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2019-07-12

Study results available
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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.

Conditions

  • Tobacco Cessation

Interventions

OTHER

Placebo

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.

DRUG

Progesterone

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.

OTHER

Smoking Cessation Behavioral Counseling

Subjects will receive weekly smoking cessation behavioral counseling.

Sponsors & Collaborators

Principal Investigators

  • Sharon S. Allen, M.D. · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2017-07-27
Completion
2017-07-27

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01744574 on ClinicalTrials.gov