Acute Effects of THC in Older Adult

ConditionAge-related Cognitive Decline

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age21+

SponsorYale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

Delta-9-THC Low Dose
Drug
Active Delta-9-THC administered intravenously over 20 minutes.
Placebo
Drug
Small amount of sterile ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.
Delta-9-THC Medium Dose
Drug
Active Delta-9-THC administered intravenously over 20 minutes

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: Delta-9-THC Very Low DoseActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Group C: Delta-9-THC Medium DoseActive comparator 1 intervention

Trial outcomes

Primary outcomes

Rey Auditory Verbal Learning Task (RAVLT) total immediate recall

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

Time frame

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

Visual Analog Scale (VAS)

Various feeling states will be measured using a self-reported visual analog scale of feeling states (ex: "calm and relaxed", and "tired") associated with drug administration. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 100 mm line (0 = not at all, 100 = extremely). A higher score reflects a positive response.

Time frame

-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.

Sponsors and contacts

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Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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