N/A
Completed N=45
Progesterone for the Treatment of Cocaine Dependence - 1
Cocaine Abuse · Cocaine-Related Disorders
Source: ClinicalTrials.gov NCT00218257 ↗
Enrolled (actual)
45
Serious AEs
1.3%
Results posted
Oct 2020
Primary outcomePrimary: Decision to Self-Administer Cocaine — 66; 66; 32; 32 percent of available doses
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decision to Self-Administer Cocaine |
66; 66; 32; 32 | — |
| SECONDARY Heart Rate |
87.9; 87.2; 77.6; 74.6 | — |
| SECONDARY Systolic Blood Pressure |
129.9; 131.8; 117.4; 120.2 | — |
| SECONDARY Diastolic Blood Pressure |
77.6; 78.6; 71.3; 72.2 | — |
| SECONDARY Cocaine Craving |
3.99; 4.02; 2.06; 1.38 | — |
Eligibility Criteria
Inclusion Criteria
- Smoked at least 1 gram of cocaine each week for the 6 months prior to study entry
- Agrees to use an adequate method of contraception for the duration of the study
- If female, current regular menses
Exclusion Criteria
- Major psychiatric illnesses, including psychotic mood and anxiety disorders
- Current dependence on alcohol or drugs other that cocaine or nicotine
- History of major medical illnesses, including liver disease, abnormal vaginal bleeding, suspected or known breast cancer, thrombophlebitis, or other medical conditions
- Current use of oral contraceptives or other types of hormonal contraceptives
- Amenorrhea
- Currently on parole or probation
- Received treatment for chemical dependency within the 6 months prior to study entry
- Known allergy to progesterone or peanuts
Data sourced from ClinicalTrials.gov (NCT00218257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.