NCT06948136

Brief Summary

The primary objective of this study is to determine if increasing age confers greater vulnerability to the acute A) cognitive (e.g., memory, attention, psychomotor function), B) subjective (e.g., anxiogenic and rewarding effects), and C) cardiovascular (heart rate and blood pressure), effects of THC in adults \> 21 years old. The secondary aims of the study are to explore age-related acute effects of THC on electrophysiological indices of information processing (e.g., auditory steady-state response (ASSR), oddball paradigm \[P300\], and resting state cortical noise) and to determine age-related differences in the metabolism of THC.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
18mo left

Started Jun 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Jun 2025Nov 2027

First Submitted

Initial submission to the registry

January 21, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 6, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

August 18, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

January 21, 2025

Last Update Submit

August 14, 2025

Conditions

Age-related Cognitive Decline

Outcome Measures

Primary Outcomes (1)

  • Rey Auditory Verbal Learning Task (RAVLT) total immediate recall

    The task consists of 5 trials, an interference list, free delayed recall, and recognition.

    Each test day will be split into two drug administration sessions. The RAVLT will be administered approximately 25 minutes after each drug administration.

Secondary Outcomes (1)

  • Visual Analog Scale (VAS)

    -60 minutes, 20 minutes, 60 minutes, 120 minutes, 170 minutes, 210 minutes, 270 minutes, 300 minutes, 360 minutes, 420 minutes after the start of the initial THC/placebo drug infusion.

Study Arms (3)

Delta-9-THC Very Low Dose

ACTIVE COMPARATOR

Active delta-9-THC administered intravenously over 20 minutes.

Drug: Delta-9-THC Low Dose

Placebo

PLACEBO COMPARATOR

Control: Small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, over 20 minutes.

Drug: Placebo

Delta-9-THC Medium Dose

ACTIVE COMPARATOR

Active delta-9-THC administered intravenously over 20 minutes.

Drug: Delta-9-THC Medium Dose

Interventions

Delta-9-THC Low DoseDRUG

Active Delta-9-THC administered intravenously over 20 minutes.

Delta-9-THC Very Low Dose
PlaceboDRUG

Small amount of sterile ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.

Placebo
Delta-9-THC Medium DoseDRUG

Active Delta-9-THC administered intravenously over 20 minutes

Delta-9-THC Medium Dose

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* Ability to provide informed consent * No history (current or past) of unstable or serious medical, neurological or psychiatric conditions. * High school education or greater * No positive pregnancy test and/or lactation/ planning to nurse while in this study * English speaking

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

RECRUITING

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Deepak C D'Souza, MD

    Yale University School of Medicine; VA Connecticut Healthcare System

    PRINCIPAL INVESTIGATOR

  • Ashley Schnakenberg Martin, PhD

    Yale University School of Medicine; VA Connecticut Healthcare System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepak C D'Souza

CONTACT

203-932-5711deepak.douza@yale.edu

Ashley Schnakenberg Martin, PhD

CONTACT

ashley.martin@yale.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

January 21, 2025

First Posted

April 29, 2025

Study Start

June 6, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

August 18, 2025

Record last verified: 2025-08

Locations

US(1)