Age-related Cognitive Decline
Conditions
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.
Interventions
DRUGDelta-9-THC Low Dose
Active Delta-9-THC administered intravenously over 20 minutes.
DRUGPlacebo
Small amount of sterile ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.
Active Delta-9-THC administered intravenously over 20 minutes
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rey Auditory Verbal Learning Task (RAVLT) total immediate recall | Each test day will be split into two drug administration sessions. The RAVLT will be administered approximately 25 minutes after each drug administration. | The task consists of 5 trials, an interference list, free delayed recall, and recognition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Contacts
Primary ContactDeepak C D'Souza
Backup ContactAshley Schnakenberg Martin, PhD
Outcome results
None listed