Marijuana Dependence
Conditions
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).
Interventions
DRUGProgesterone
generic progesterone
DRUGplacebo
placebo
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Marijuana Use as Defined by the TLFB | 5 weeks. Baseline to week 4 | Marijuana use as defined by the TLFB at the week 4 visit relative to the baseline visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Progesterone - Males 200 mg progesterone BID
Progesterone: generic progesterone | 23 |
| Placebo - Males placebo BID
placebo: placebo | 23 |
| Progesterone - Females 200 mg progesterone BID
Progesterone: generic progesterone | 6 |
| Placebo - Females placebo BID
placebo: placebo | 6 |
| Total | 58 |
Baseline characteristics
| Characteristic | Progesterone - Males | Placebo - Males | Progesterone - Females | Placebo - Females | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38.7 years STANDARD_DEVIATION 11.3 | 40.7 years STANDARD_DEVIATION 10.9 | 34.0 years STANDARD_DEVIATION 7.7 | 37.0 years STANDARD_DEVIATION 7.6 | 38.8 years STANDARD_DEVIATION 10.5 |
| Baseline MJ use per day | 14.7 MJ use occasions per day STANDARD_DEVIATION 6.2 | 13.9 MJ use occasions per day STANDARD_DEVIATION 8.6 | 12.6 MJ use occasions per day STANDARD_DEVIATION 8.6 | 12.0 MJ use occasions per day STANDARD_DEVIATION 4.4 | 14.7 MJ use occasions per day STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 9 Participants | 1 Participants | 1 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 13 Participants | 12 Participants | 2 Participants | 2 Participants | 29 Participants |
| Region of Enrollment United States | 23 participants | 23 participants | 6 participants | 6 participants | 58 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 23 Participants | 23 Participants | 0 Participants | 0 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 23 | 0 / 23 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 | 0 / 6 | 0 / 6 |
Outcome results
Primary
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.
Time frame: 5 weeks. Baseline to week 4
Population: Some participant data was not included in the analysis because it was missing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Males - Progesterone | Change in Marijuana Use as Defined by the TLFB | -1.7 MJ use occasions per day | Standard Deviation 0.8 |
| Males - Placebo | Change in Marijuana Use as Defined by the TLFB | -1.4 MJ use occasions per day | Standard Deviation 1.1 |
| Females - Progesterone | Change in Marijuana Use as Defined by the TLFB | -0.9 MJ use occasions per day | Standard Deviation 1 |
| Females - Placebo | Change in Marijuana Use as Defined by the TLFB | -2.9 MJ use occasions per day | Standard Deviation 1 |