CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 60 enrolled
Drug / intervention
Dronabinol +1 moredrug
Likely dose
Dronabinol 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03809546
NCT03809546Early Ph 1Completed

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

University of Chicago·interventional·Posted Jan 18, 2019·Updated Jul 3, 2024

In Brief

A Early Phase 1 clinical trial evaluating Dronabinol and dextrose for Differential Female Response to Δ9-tetrahydrocannabinol (THC). Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedJan 18, 2019
Enrollment StartNov 6, 2018
Primary CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.5 years ago

Interventions

Dronabinoldrug

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).

dextrosedrug

We are administering dextrose to health volunteers for our placebo group