Phase 2
N=148
Impact of Progesterone on Stress Reactivity and Cannabis Use
Cannabis Use
Bottom Line
View on ClinicalTrials.gov: NCT03729869 ↗Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Cannabis Craving — 3.7; 3.4; 4.3; 4.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Progesterone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cannabis Craving |
3.7; 3.4; 4.3; 4.5 | — |
Summary
This is a research study to find out if a hormone called progesterone affects marijuana users' stress response and marijuana use. Progesterone is a naturally occurring sex hormone involved in the menstrual cycle and reproduction, and has been shown to reduce withdrawal symptoms when people stop using substances like cocaine and nicotine. It is not FDA approved for treating cannabis users and is considered an investigational drug in this study.
Eligibility Criteria
Inclusion Criteria
- 1. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Meet DSM-5 criteria for moderate or severe cannabis use disorder (within the past three months) and report using cannabis at least five times weekly over the past month. While individuals may also meet criteria for mild use disorders of other substances, they must identify cannabis as their primary substance of abuse and must not meet criteria for any other moderate or severe substance use disorder (except tobacco) within the last 60 days.
- Age 18-45. 4. For women, regular menses (every 25-35 days). 5. 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.
- Women of childbearing potential must agree to utilize an effective means of birth control.
- Must consent to random assignment.
Exclusion Criteria
- . Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Women who are amennorheic or using progesterone-based contraceptives. 3. Evidence or 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 individual to be in the study.
- History of or current psychotic disorder or bipolar affective disorder. 5. Current suicidal or homicidal ideation/risk. 6. 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 or severe substance use disorder (other than nicotine or cannabis) within the past 60 days.
- Unable to comply with study procedures or pose threat to study staff.
Data sourced from ClinicalTrials.gov (NCT03729869). 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.