Impact of Progesterone on Stress Reactivity and Cannabis Use

NCT03729869 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: Pro000813602U54DA016511-16
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study to find out if a hormone called progesterone affects marijuana users' stress response and marijuana use. Progesterone is a naturally occurring sex hormone involved in the menstrual cycle and reproduction, and has been shown to reduce withdrawal symptoms when people stop using substances like cocaine and nicotine. It is not FDA approved for treating cannabis users and is considered an investigational drug in this study.

Conditions

Cannabis Use

Outcome Measures

Primary Outcomes (1)

• Cannabis Craving

  Subjects will rate marijuana craving on a 0-7 Likert scale where 0 is Not at All and 7 is extremely.

  Immediately post stress/cue task.

Study Arms (4)

Progesterone Males

EXPERIMENTAL

35 men will take 400 mg of progesterone a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose.

Drug: Progesterone

Placebo Males

PLACEBO COMPARATOR

35 men will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose.

Drug: Placebo

Progesterone Female

EXPERIMENTAL

35 women will take 200 mg of progesterone twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose.

Drug: Progesterone

Placebo Females

PLACEBO COMPARATOR

35 women will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose.

Drug: Placebo

Interventions

Progesterone DRUG

200 mg of exogenous progesterone twice a day

Also known as: Prometrium

Progesterone Female; Progesterone Males

Placebo DRUG

One dose of matched placebo twice a day.

Placebo Females; Placebo Males

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
• \. Meet DSM-5 criteria for moderate or severe cannabis use disorder (within the past three months) and report using cannabis at least five times weekly over the past month. While individuals may also meet criteria for mild use disorders of other substances, they must identify cannabis as their primary substance of abuse and must not meet criteria for any other moderate or severe substance use disorder (except tobacco) within the last 60 days.
• \. Age 18-45. 4. For women, regular menses (every 25-35 days). 5. Consent to remain abstinent from alcohol for 12 hours prior to study visits, and all other drugs other than cannabis or nicotine for the duration of the study.
• \. Women of childbearing potential must agree to utilize an effective means of birth control.
• \. Must consent to random assignment.

You may not qualify if:

• Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
• \. Women who are amennorheic or using progesterone-based contraceptives. 3. Evidence or history of major medical illnesses, including liver diseases, abnormal vaginal bleeding, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the investigator deems as contraindicated for the individual to be in the study.
• \. History of or current psychotic disorder or bipolar affective disorder. 5. Current suicidal or homicidal ideation/risk. 6. Known allergy to progesterone or peanuts (vehicle for micronized progesterone).
• \. Unwilling or unable to maintain abstinence from alcohol 12 hours prior to study visits and all other drugs other than cannabis or nicotine for the duration of the study.
• \. Meet DSM-5 criteria for moderate or severe substance use disorder (other than nicotine or cannabis) within the past 60 days.
• \. Unable to comply with study procedures or pose threat to study staff.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Interventions

Progesterone

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: Lisa Nunn, Program Manager
• Organization: Medical University of South Carolina

jenkinli@musc.edu

843-792-0476

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: January 18, 2019
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)