Progesterone Treatment in Female Smokers - 12

Tobacco Use Disorder Clinical Trial

Official title:

Progesterone Treatment in Female Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000295
• Other study ID #: NIDA-09259-12
• Secondary ID: P50-09259-12
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: January 11, 2017
• Start date: April 1999
• Est. completion date: December 2001

Study information

• Verified date: April 1999
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate progesterone effects in female smokers

Description:

Limited research has been done on the effects of gender and menstrual cycle in response to drugs of abuse in humans. The main goal of this pilot study is to investigate the safety and tolerability of progesterone treatment in female nicotine users. In addition, plasma progesterone levels reached with a single 200 mg dose of progesterone treatment will be measured. The study will be a double-blind placebo controlled, crossover trial in which 12 female smokers who are in the early follicular phase of their menstrual cycle will be enrolled. Druing the experimental sessions, subjects will be given a single 200 mg dose of micronized progesterone or placebo and multiple blood samples will be obtained to measure the plasma levels of progesterone. Starting 2 hours after progesterone or placebo treatment, subjects will have a self-administration period that will last around 2.5 hours. We hypothesize that administration of 200 mg of progesterone will achieve plasma progesterone concentrations similar to those found in the luteal phase of the menstrual cycle, 3-30 ng/ml.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

Female subjects aged 21-45 years with a smoking history of at least 20 cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests. Not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods other than hormonal contraceptives.

Exclusion Criteria:

History of heart disease, peripheral vascular disease, COPD, liver diseases, abnormal vaginal bleeding, suspected or known breast malignancy, or any other medical condition which physician investigator deems inappropriate for subject participation. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history. Amenorrhea. Current use of oral or other types of hormonal contraceptives. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products. Known allergy to progesterone or peanuts.

Study Design

Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Micronized Progesterone

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral
Primary	Subjective
Primary	Biochemical