Individual Differences in Drug Response

NCT03809546 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB18-1286
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Differential Female Response to Δ9-tetrahydrocannabinol (THC)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Profile of Mood States (POMS)

  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.

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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: dextrose

7.5 mg THC

ACTIVE COMPARATOR

Drug: Dronabinol

15 mg THC

ACTIVE COMPARATOR

Drug: Dronabinol

Interventions

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).

15 mg THC; 7.5 mg THC

dextrose DRUG

We are administering dextrose to health volunteers for our placebo group

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60615, United States

Location

MeSH Terms

Interventions

Dronabinol; Glucose

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Harriet de Wit
• Organization: University of Chicago

dewitlab@yoda.bsd.uchicago.edu

7737023560

Study Officials

• Elisa Pabon

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 18, 2019
• Study Start: November 6, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)