ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 699 for:    marijuana

Hormones and Reduction in Co-users of Marijuana and Nicotine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02579421
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Marijuana Dependence Drug: Progesterone Drug: placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sex Differences and Progesterone: Association With Impulsivity and Marijuana Reduction in Co-Users of Marijuana and Nicotine Cigarettes
Study Start Date : November 2015
Actual Primary Completion Date : July 27, 2017
Actual Study Completion Date : July 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: Progesterone
200 mg progesterone BID
Drug: Progesterone
generic progesterone
Other Name: Promitrium, Crinone, Endometrin, Prochieve

Placebo Comparator: placebo
placebo BID
Drug: placebo
placebo




Primary Outcome Measures :
  1. Change in marijuana use as defined by the TLFB [ Time Frame: 5 weeks. Baseline to week 4 ]
    Marijuana use as defined by the TLFB at the week 4 visit relative to the baseline visit.


Secondary Outcome Measures :
  1. Change in marijuana use as defined by THC Urine Dipstick Test [ Time Frame: 5 weeks. Baseline to week 4 ]
    Marijuana use as defined by the THC Urine Dipstick Test at the week 4 visit relative to the baseline visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579421


Locations
United States, Minnesota
Delaware Clinical Research Unit, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Sharon Allen, Ph.D,M.D. University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02579421     History of Changes
Other Study ID Numbers: 1509M78103
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Progesterone
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists