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Trial record 16 of 95 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | marijuana | United States

Impact of Progesterone on Stress Reactivity and Cannabis Use

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ClinicalTrials.gov Identifier: NCT03729869
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Cannabis Use Drug: Progesterone Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Progesterone on Stress Reactivity and Cannabis Use
Actual Study Start Date : January 18, 2019
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Progesterone Males
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
200 mg of exogenous progesterone twice a day
Other Name: Prometrium

Placebo Comparator: Placebo Males
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
One dose of matched placebo twice a day.

Experimental: Progesterone Female
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
200 mg of exogenous progesterone twice a day
Other Name: Prometrium

Placebo Comparator: Placebo Females
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
One dose of matched placebo twice a day.




Primary Outcome Measures :
  1. Cannabis Craving [ Time Frame: Immediately post stress/cue task. ]
    Subjects will rate marijuana craving on a 0-10 Likert scale where 0 is Not at All and 10 is extremely.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729869


Contacts
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Contact: Aimee McRae-Clark, PharmD 843-792-5216 mcraeal@musc.edu
Contact: Lisa Nunn, MS 843-792-0476 jenkinli@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29403
Contact: Lisa Nunn, MS    843-792-0476    jenkinli@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)

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Responsible Party: Aimee McRae-Clark, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03729869     History of Changes
Other Study ID Numbers: Pro00081360
2U54DA016511-16 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs