Hormones and Reduction in Co-users of Marijuana and Nicotine

University of Minnesota (UMN)

Status: Completed

Conditions: Marijuana Dependence

Treatments: Drug: placebo; Drug: Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT02579421

2015NTLS141

Details and patient eligibility

About

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.

Full 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).

Enrollment: 58 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 4 patient groups, including a placebo group

Males - Progesterone

Active Comparator group

Description:

200 mg progesterone BID

Treatment:

Drug: Progesterone

Males - Placebo

Placebo Comparator group

Description:

placebo BID

Treatment:

Drug: placebo

Females - Progesterone

Active Comparator group

Description:

200 mg progesterone BID

Treatment:

Drug: Progesterone

Females - Placebo

Placebo Comparator group

Description:

placebo BID

Treatment:

Drug: placebo