Age-Related Effects of THC

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2021-05-01

Brief Summary

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Increased accessibility to cannabis and its primary psychoactive constituent THC has raised public health concerns. One major concern surrounds the potential risks associated with acute THC intoxication and who might be most at risk. A second major concern is the need to develop sensitive measures that can detect THC intoxication after recent use and enable robust comparisons of intoxication to determine sources of risk. One potential source of risk is age, specifically during the period of adolescence.

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Detailed Description

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There is limited knowledge on the effects of THC in adolescents vs adults. One recent report compared responses to vaporized cannabis in heavy adolescent vs adult cannabis users and found that the adolescents were less sensitive to the drug on most measures. However, their findings were complicated by several factors: i) the study used vaporized cannabis, which may have other constituents and does not offer full control of the dose, ii) the participants were heavy users, making it difficult to determine the influence of prior drug exposure, and iii) the participants were not drug-free at the time of testing. Prior exposure to THC can lead to tolerance, and adolescents and adults may differ in the rate at which they develop tolerance, consistent with changes in CB1R receptor function. Our study will compare adolescent (here, aged 18 to 20) and adult (here, aged 30 to 40) responses to THC in relatively light cannabis users who are drug-free at the time of testing.

Conditions

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Tolerance Adolescent Behavior THC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Dextrose

Intervention Type DRUG

Administering dextrose to healthy 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.

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.

Interventions

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Dextrose

Administering dextrose to healthy volunteers for our placebo group

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-20 years old OR 30-40 years old
* Body Mass Index 19-26
* High school education, fluent in English
* Occasional cannabis users ( 0 times in past 30 days AND used cannabis no more than 20 times in lifetime)

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
* Cardiovascular illness, high blood pressure, abnormal electrocardiogram
* Current medications
* Pregnant or planning to become pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes