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Individual Differences in Drug Response (IDT)

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ClinicalTrials.gov Identifier: NCT03809546
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
Females are increasingly using cannabis, yet remain underrepresented in preclinical and clinical cannabinoid research. This female-specific research plan will test the effects of two recreationally relevant doses of oral THC and placebo in healthy females at two phases of the menstrual cycle. Acute oral THC will be administered in a double-blind and counterbalanced design. Menstrual cycle phase will be determined using blood serum analyses of estradiol and progesterone and self-reported responses. The main hypothesis is circulating estradiol levels are associated with cardiac, neuroendocrine, and subjective THC response. The rationale for the presented work is to better understand the risks of cannabis use, in order to maximize possible medical potential and minimize public health risks. The expected outcome of this work is a deeper understanding of how circulating estradiol levels may associate with response to THC and how the physiological response is associated with the subjective response. Uncovering the individual differences in response to THC will allow for more preventive action against cannabis-induced anxiety, paranoia, and psychosis.

Condition or disease Intervention/treatment Phase
Differential Female Response to Δ9-tetrahydrocannabinol (THC): The Influence of Estradiol Drug: Dronabinol Drug: dextrose Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Differential Female Response to Δ9-tetrahydrocannabinol (THC): The Influence of Estradiol
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: dextrose
We are administering dextrose to health volunteers for our placebo group

Active Comparator: 10 mg THC Drug: Dronabinol
THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 10 mg and 20 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).

Active Comparator: 20 mg THC Drug: Dronabinol
THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 10 mg and 20 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).




Primary Outcome Measures :
  1. Change From Baseline in Profile of Mood States (POMS) [ Time Frame: End of study (Baseline - time 0 and approximately 4 weeks later) ]
    The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assess six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger - Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of this instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-35 years old, females (N=60)
  • BMI 19-26
  • High school education, fluent in English
  • Occasional cannabis users ( <11 times in past 30 days)

Exclusion Criteria:

  • History of daily cannabis use
  • Past or present severe substance use disorder
  • Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia
  • Past year major depression
  • Current or past PTSD
  • ADHD
  • Cardiovascular illness, high blood pressure, abnormal EKG
  • Current medications (NO hormonal birth control or IUD)
  • Pregnant or planning to become pregnant

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): NCT03809546


Contacts
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Contact: Matthew Bona 773-702-3560 mbona@yoda.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60615
Contact: Matthew Bona    773-702-3560    mbona@yoda.bsd.uchicago.edu   
Contact: Elisa Pabon    773-702-7611    epabon@uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Elisa Pabon University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03809546     History of Changes
Other Study ID Numbers: IDT
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 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.: No

Additional relevant MeSH terms:
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Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists