Hormones and Reduction in Co-users of Marijuana and Nicotine

NCT02579421 | Completed Results DMC

• 1 other identifier: 2015NTLS141
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Marijuana Dependence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Males - Progesterone

ACTIVE COMPARATOR

200 mg progesterone BID

Drug: Progesterone

Males - Placebo

PLACEBO COMPARATOR

placebo BID

Drug: placebo

Females - Progesterone

ACTIVE COMPARATOR

200 mg progesterone BID

Drug: Progesterone

Females - Placebo

PLACEBO COMPARATOR

placebo BID

Drug: placebo

Interventions

Progesterone DRUG

generic progesterone

Also known as: Promitrium, Crinone, Endometrin, Prochieve

Females - Progesterone; Males - Progesterone

placebo DRUG

placebo

Females - Placebo; Males - Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Delaware Clinical Research Unit, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Progesterone; Crinone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: Dr. Sharon Allen
• Organization: University of Minnesota

allen001@umn.edu

612-624-0446

Study Officials

• Sharon Allen, Ph.D,M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 19, 2015
• Study Start: November 1, 2015
• Primary Completion: July 27, 2017
• Study Completion: July 27, 2017
• Last Updated: June 26, 2020
• Results First Posted: July 10, 2019

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)