Marijuana Dependence Clinical Trial
Official title:
Sex Differences and Progesterone: Association With Impulsivity and Marijuana Reduction in Co-Users of Marijuana and Nicotine Cigarettes
NCT number | NCT02579421 |
Other study ID # | 2015NTLS141 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | July 27, 2017 |
Verified date | June 2020 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | July 27, 2017 |
Est. primary completion date | July 27, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Delaware Clinical Research Unit, University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Marijuana Use as Defined by the TLFB | Marijuana use as defined by the TLFB at the week 4 visit relative to the baseline visit. | 5 weeks. Baseline to week 4 |
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