Impact of Progesterone on Stress Reactivity and Cannabis Use
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Intervention: Progesterone; Placebo
Intervention description: 200 mg of exogenous progesterone twice a day; One dose of matched placebo twice a day.
Intervention MeSH terms: Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

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.

             2. 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.

             3. 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.

             6. Women of childbearing potential must agree to utilize an effective means of birth
             control.

             7. 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.

             2. 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.

             4. 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).

             7. 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.

             8. Meet DSM-5 criteria for moderate or severe substance use disorder (other than
             nicotine or cannabis) within the past 60 days.

             9. Unable to comply with study procedures or pose threat to study staff.