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Completed

NCT Number: NCT03809546

Individual Differences in Drug Response

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.

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Key information

Conditions

Differential Female Response to Δ9-tetrahydrocannabinol (THC)

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Chicago

Chicago, Illinois, 60615, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-35 years old, females (N=60)
  • Body Mass Index 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 Post Traumatic Stress Disorder
  • Attention Deficit Hyperactivity Disorder
  • Cardiovascular illness, high blood pressure, abnormal electrocardiagram
  • Current medications (NO hormonal birth control or intrauterine device)
  • Pregnant or planning to become pregnant

Treatment and study plan

Dronabinol

Drug

THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 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).

Dextrose

Drug

We are administering dextrose to health volunteers for our placebo group

Primary outcomes

  1. Change From Baseline in Profile of Mood States (POMS)

    Time frame: Difference from baseline (time 0 or pre-capsule) to post-capsule (120 min)

    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. Subscale scores range from 0-20. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Differential Female Response to Δ9-tetrahydrocannabinol (THC): The Influence of Estradiol

Acronym: IDT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2019
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.