Acute Effects of THC in Older Adult
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Delta-9-THC Low Dose, Placebo, Delta-9-THC Medium Dose.
- Who it may be relevant to
- Registry conditions: Age-related Cognitive Decline. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Delta-9-THC Low Dose
Active Delta-9-THC administered intravenously over 20 minutes. - Drug Placebo
Small amount of sterile ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes. - Drug Delta-9-THC Medium Dose
Active Delta-9-THC administered intravenously over 20 minutes
Primary outcome measures
- Rey Auditory Verbal Learning Task (RAVLT) total immediate recall [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 outcome measures (1)
- Visual Analog Scale (VAS) [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.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- VA Connecticut Healthcare System — West Haven
Identifiers
NCT: NCT06948136 · 2000038388 · 1R21DA058138-01A1