NCT02579421

Hormones and Reduction in Co-users of Marijuana and Nicotine

Sex Differences and Progesterone: Association With Impulsivity and Marijuana Reduction in Co-Users of Marijuana and Nicotine Cigarettes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This double-blind, randomized pilot clinical trial will prescreen an estimated 250 potential subjects, consent and further evaluate approximately 100 potential subjects, and ultimately enroll 70 subjects to ensure 40 subjects will provide a primary marijuana reduction outcome measure at four weeks post quit date. Subjects will be stratified by sex then randomized to one of two treatment groups (n=20 per drug group, 50% female): progesterone (PRO; 200mg 2x/day) or Placebo (PBO). Telephone screening and visit invitation (20 minutes) leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion (two visits, two hours each), then randomization and medication start (7 days), then stable medication (28 days) with medication reduction and final evaluation (7 days).

Conditions

• Marijuana Dependence

Interventions

Type	Name	Description
DRUG	Progesterone	generic progesterone
DRUG	placebo	placebo

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-07-27
• Completion: 2017-07-27
• First posted: 2015-10-19
• Last updated: 2020-06-26
• Results posted: 2019-07-10

Locations

1 site across 1 country: United States