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Impact of Progesterone on Stress Reactivity and Cannabis Use

Primary Purpose

Cannabis Use

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Progesterone

Placebo

About this trial

This is an interventional treatment trial for Cannabis Use

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
2. 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.
3. 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.
6. Women of childbearing potential must agree to utilize an effective means of birth control.
7. Must consent to random assignment.

Exclusion Criteria:

. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
2. 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.
4. 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).
7. 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.
8. Meet DSM-5 criteria for moderate or severe substance use disorder (other than nicotine or cannabis) within the past 60 days.
9. Unable to comply with study procedures or pose threat to study staff.

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Progesterone Males

Placebo Males

Progesterone Female

Placebo Females

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Cannabis Craving

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03729869

First Posted

November 1, 2018

Last Updated

September 27, 2023

Sponsor

Medical University of South Carolina

Collaborators

National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03729869

Brief Title

Impact of Progesterone on Stress Reactivity and Cannabis Use

Official Title

Impact of Progesterone on Stress Reactivity and Cannabis Use

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

January 18, 2019 (Actual)

Primary Completion Date

November 9, 2022 (Actual)

Study Completion Date

November 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

Collaborators

National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Participants will complete a screening visit to determine study eligibility. Eligible subjects will be scheduled to begin 22 days of study participation. During the first week, participants will be randomly assigned to take either progesterone or placebo (inactive medication) twice a day, and to abstain from marijuana use. During this week, participants will upload videos of themselves taking their medication and performing saliva drug tests. They will collect and store additional saliva samples each morning for hormone testing. They will also participate in "CREMA" sessions (Cue Reactivity Ecologic Momentary Assessment) three times a day. These sessions include looking at stressful and neutral pictures and rating stress and craving. At the end of this week, participants will return to the clinic and participate in a stress task. For the next two weeks, participants will continue to collect saliva samples and participate in CREMA sessions. They will return at the end of the two weeks to return study supplies. Urine samples will be collected at each study visit.

6. Conditions and Keywords

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

Cannabis Use

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Progesterone Males

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo Males

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Progesterone Female

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo Females

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Progesterone

Other Intervention Name(s)

Prometrium

Intervention Description

200 mg of exogenous progesterone twice a day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

One dose of matched placebo twice a day.

Primary Outcome Measure Information:

Title

Cannabis Craving

Description

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

Time Frame

Immediately post stress/cue task.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 2. 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. 3. 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. 6. Women of childbearing potential must agree to utilize an effective means of birth control. 7. Must consent to random assignment. Exclusion Criteria: . Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. 2. 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. 4. 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). 7. 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. 8. Meet DSM-5 criteria for moderate or severe substance use disorder (other than nicotine or cannabis) within the past 60 days. 9. Unable to comply with study procedures or pose threat to study staff.

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29403

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Impact of Progesterone on Stress Reactivity and Cannabis Use

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