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Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation


N/A
18 Years
40 Years
Open (Enrolling)
Both
Tobacco Cessation

Thank you

Trial Information

Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation


Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO)
or placebo (PBO).

Telephone screening and visit invitation leads to the consent process and in-person
screening including medical-psychiatric evaluation for inclusion/exclusion, then
randomization and medication induction, stable medication with medication reduction and
final evaluation for secondary outcomes.


Inclusion Criteria:



- Male or female between 18 and 40 years old

- Self-report regular smoking

- Motivated to quit smoking

- In stable physical/mental health

- Self report of regular menstrual cycles (female only)

- English fluency

- Understand the study procedures and able to provide informed consent

- Ability to participate fully in research elements for the duration of the trial.

Exclusion Criteria:

- Current or recent (< 3 months) breastfeeding (females only)

- Current or planned pregnancy within the next three months (females only)

- Conditions contraindicated to progesterone treatment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Comparison of Subjects Who Relapsed - Male and Female

Outcome Description:

Our primary outcome is the binary indicator of relapsed yes/no at the week 4 visit. An unadjusted assessment of the treatment effect will come from a logistic regression of this binary outcome on randomized treatment assignment, separately by sex. All persons randomized and with a measured primary outcome at the week 4 visit will be included in this analysis, regardless of whether or not they ever took any of their assigned treatment (intent-to-treat analysis).

Outcome Time Frame:

Week 4

Safety Issue:

No

Principal Investigator

Sharon S. Allen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2012NTLS074

NCT ID:

NCT01744574

Start Date:

December 2012

Completion Date:

September 2017

Related Keywords:

  • Tobacco Cessation

Name

Location
Delaware Clinical Research Unit, University of Minnesota Minneapolis, Minnesota  55455