Individual Differences in Drug Response

NCT ID: NCT03809546

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-06
• Study Completion Date: 2021-06-01

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

dextrose

Intervention Type: DRUG

We are administering dextrose to health volunteers for our placebo group

7.5 mg THC

Group Type: ACTIVE_COMPARATOR

Dronabinol

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Dronabinol

Intervention Type: 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).

Interventions

Dronabinol

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).

Intervention Type: DRUG

dextrose

We are administering dextrose to health volunteers for our placebo group

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisa Pabon

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB18-1286

Identifier Type: -

Identifier Source: org_study_id