CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
Progesterone +1 moredrug
Likely dose
Progesterone 200 mg orally twice dailyAI-extracted
Key inclusion· 2
  • ✓Smoked at least 1 gram of cocaine per week for the 6 months prior to study entry
  • ✓Current regular menses
Key exclusion· 7
  • ✕Major psychiatric illnesses, including psychotic mood and anxiety disorders
  • ✕Current dependence on alcohol or drugs other than cocaine or nicotine
  • ✕History of major medical illnesses including liver disease, abnormal vaginal bleeding, suspected or known breast cancer, thrombophlebitis
  • ✕Current use of oral contraceptives or other types of hormonal contraceptives

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

Search/NCT00218257
NCT00218257N/ACompleted
CompareCT.gov

Interactions Between Progesterone and Cocaine in Women

University of Minnesota·interventional·Posted Sep 22, 2005·Updated Oct 8, 2020

In Brief

A clinical study evaluating Progesterone and Placebo for Cocaine Abuse and Cocaine-Related Disorders. Completed, enrolled 96 participants across 1 site.

Detailed Summary

Past research has demonstrated that cocaine dependent women experience less severe responses to cocaine during the luteal phase of the menstrual cycle, when estrogen and progesterone concentrations are high. The purpose of this study is to determine whether administered progesterone reduces subjective and physiological responses to cocaine in cocaine dependent individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Abuse, Cocaine-Related Disorders
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartJul 1, 2002
Primary CompletionApr 1, 2008
Study CompletionJun 30, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.8 years ago

Interventions

Progesteronedrug

200mg progesterone twice daily

Placeboother

placebo