Hormones and Reduction in Co-users of Marijuana and Nicotine

• Status: Completed
• Trial end date: 2017-07-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the role of progesterone (a naturally occurring hormone found in both men and women) on reducing marijuana use. The investigators will see if progesterone effects impulsivity, withdrawal, mood and stress during marijuana cessation.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Nicotine; Progesterone

Criteria

Inclusion Criteria:

• Males 18-60 years old, females 18-50 years old

• Stable physical and mental health

• Self-report Timeline Follow-Back (TLFB) indicating current marijuana use ≥4 days/week for ≥1 year

• Positive urine THC dipstick test (> 50ng/mL; indicating marijuana use in the past 48-72 hours)

• Motivated to change their marijuana use (>1 on a 10-point Likert-type scale) -Regular or sporadic use of nicotine cigarettes (> 1 cigarettes in the past 30 days) -Self-report of regular menstrual cycles >6 months (female only)

• Willing to use double-barrier contraception if sexually active and not surgically sterilized (female only)

• Ability to comply with study procedures, ability to provide informed consent.

Exclusion Criteria:

• Current breastfeeding (females only),

• Current or planned pregnancy within the next three months (females only)

• DSM-IV diagnoses for psychotic disorders, bipolar disorder, ADHD, major depressive disorder within the last 3 months

• Substance dependence within the last 3 months with the exception of nicotine and marijuana dependence

• Unstable psychotropic medications (<3 months)

• Current use of exogenous hormones, finasteroid (propecia), efavirenz, red clover, ketoconazole and other drugs that are CYP3A4 inhibitors

• Conditions contraindicated to progesterone treatment (including, but not limited to, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke, allergy to peanuts, hypersensitive to progesterone and liver dysfunction)