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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 : July 21, 2021
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

Tracking Information
First Submitted Date  ICMJE November 1, 2018
First Posted Date  ICMJE November 5, 2018
Last Update Posted Date July 21, 2021
Actual Study Start Date  ICMJE January 18, 2019
Estimated Primary Completion Date October 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Progesterone on Stress Reactivity and Cannabis Use
Official Title  ICMJE Impact of Progesterone on Stress Reactivity and Cannabis Use
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cannabis Use
Intervention  ICMJE
  • Drug: Progesterone
    200 mg of exogenous progesterone twice a day
    Other Name: Prometrium
  • Drug: Placebo
    One dose of matched placebo twice a day.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Progesterone
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Progesterone
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2023
Estimated Primary Completion Date October 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aimee McRae-Clark, PharmD 843-792-5216 mcraeal@musc.edu
Contact: Lisa Nunn, MS 843-792-0476 jenkinli@musc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729869
Other Study ID Numbers  ICMJE Pro00081360
2U54DA016511-16 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aimee McRae-Clark, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP