Status:
COMPLETED
Progesterone for Cannabis Withdrawal
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Conditions:
Cannabis Use Disorder
Cannabis Withdrawal
Eligibility:
FEMALE
18-45 years
Phase:
EARLY_PHASE1
Brief Summary
Sex and gender differences in behavioral, biological, and clinical correlates of substance use disorders are myriad, yet there exists a dearth of gender-informed treatment options. Ovarian hormones ha...
Detailed Description
Substantial evidence demonstrates sex and gender differences in the behavioral, biological, and clinical correlates of substance use disorders. Men tend to initiate use earlier and have higher lifetim...
Eligibility Criteria
Inclusion
- Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments and study procedures.
- Age 18-45, with regular menses (every 25-35 days).
- Report using cannabis at least 5 days per week, for at least the past year.
- Consent to remain abstinent from alcohol for 12 hours prior to study visits, and all other drugs other than cannabis or nicotine for the duration of the study.
- Consent to random assignment.
Exclusion
- Participants who are pregnant, nursing, amennorheic, or using oral contraceptives.
- History of major medical illnesses; including liver diseases, abnormal vaginal bleeding, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the investigator deems as contraindicated for the patient to be in the study;
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent/current psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder.
- Current suicidal or homicidal risk. Any subject who endorses suicidal ideation will be seen by a licensed clinician in the Addiction Sciences Division who will determine the best course of action to ensure patient safety.
- Known allergy to progesterone or peanuts (vehicle for micronized progesterone).
- Unwilling or unable to maintain abstinence from alcohol 12 hours prior to study visits, and all other drugs other than cannabis or nicotine for the duration of the study.
- Meet DSM-5 criteria for moderate to severe substance use disorder (other than nicotine, cannabis, or alcohol) within the past year.
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03430050
Start Date
October 16 2017
End Date
April 4 2018
Last Update
May 22 2019
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29403