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Hormones and Reduction in Co-users of Marijuana and Nicotine

Primary Purpose

Marijuana Dependence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Progesterone

placebo

About this trial

This is an interventional treatment trial for Marijuana Dependence

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Delaware Clinical Research Unit, University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Males - Progesterone

Males - Placebo

Females - Progesterone

Females - Placebo

Arm Description

200 mg progesterone BID

placebo BID

200 mg progesterone BID

placebo BID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02579421

First Posted

October 13, 2015

Last Updated

June 24, 2020

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT02579421

Brief Title

Hormones and Reduction in Co-users of Marijuana and Nicotine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

July 27, 2017 (Actual)

Study Completion Date

July 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Marijuana Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Males - Progesterone

Arm Type

Active Comparator

Arm Description

200 mg progesterone BID

Arm Title

Males - Placebo

Arm Type

Placebo Comparator

Arm Description

placebo BID

Arm Title

Females - Progesterone

Arm Type

Active Comparator

Arm Description

200 mg progesterone BID

Arm Title

Females - Placebo

Arm Type

Placebo Comparator

Arm Description

placebo BID

Intervention Type

Drug

Intervention Name(s)

Progesterone

Other Intervention Name(s)

Promitrium, Crinone, Endometrin, Prochieve

Intervention Description

generic progesterone

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Change in Marijuana Use as Defined by the TLFB

Description

Marijuana use as defined by the TLFB at the week 4 visit relative to the baseline visit.

Time Frame

5 weeks. Baseline to week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon Allen, Ph.D,M.D.

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

Delaware Clinical Research Unit, University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Hormones and Reduction in Co-users of Marijuana and Nicotine

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