Hormones and Reduction in Co-users of Marijuana and Nicotine
Completed · Not applicable · Has a placebo group
Conditions studied: Marijuana Dependence
In brief
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.
Key facts
- Study ID
- NCT02579421
- Run by
- University of Minnesota
- People needed
- 58
- Starts
- 2015-11-01
- Expected to finish
- 2017-07-27
- Last updated by the study team
- 2020-06-26
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Delaware Clinical Research Unit, University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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