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

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.

Study Overview

• Status: Completed
• Conditions: Marijuana Dependence
• Intervention / Treatment: Drug: placebo; Drug: Progesterone

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).

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Delaware Clinical Research Unit, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Males - Progesterone; 200 mg progesterone BID	Drug: Progesterone; generic progesterone; Other Names: Promitrium, Crinone, Endometrin, Prochieve
Placebo Comparator: Males - Placebo; placebo BID	Drug: placebo; placebo
Active Comparator: Females - Progesterone; 200 mg progesterone BID	Drug: Progesterone; generic progesterone; Other Names: Promitrium, Crinone, Endometrin, Prochieve
Placebo Comparator: Females - Placebo; placebo BID	Drug: placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Sharon Allen, Ph.D,M.D., University of Minnesota

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): July 27, 2017
• Study Completion (Actual): July 27, 2017

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 2015NTLS141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO