Safety, pharmacodynamics, and pharmacokinetics of multiple oral doses of delta-9-tetrahydrocannabinol in older persons with dementia

Psychopharmacology
Amir I A AhmedMarcel G M Olde Rikkert

Abstract

Data on safety, pharmacodynamics, and pharmacokinetics of tetrahydrocannabinol (THC) are lacking in dementia patients. In this randomized, double-blind, placebo-controlled, crossover trial, we evaluated the safety, pharmacodynamics, and pharmacokinetics of THC in ten patients with dementia (mean age 77.3 ± 5.6). For 12 weeks, participants randomly received oral THC (weeks 1-6, 0.75 mg; weeks 7-12, 1.5 mg) or placebo twice daily for 3 days, separated by a 4-day washout period. Only 6 of the 98 reported adverse events were related to THC. Visual analog scale (VAS) feeling high, VAS external perception, body sway-eyes-open, and diastolic blood pressure were not significantly different with THC. After the 0.75-mg dose, VAS internal perception (0.025 units; 95% CI 0.010-0.040) and heart rate (2 beats/min; 95% CI 0.4-3.8) increased significantly. Body sway-eyes-closed increased only after 1.5 mg (0.59°/s; 95% CI 0.13-1.06). Systolic blood pressure changed significantly after both doses of THC (0.75 mg, -7 mmHg, 95% CI -11.4, -3.0; 1.5 mg, 5 mmHg, 95% CI 1.0-9.2). The median T max was 1-2 h, with THC pharmacokinetics increasing linearly with increasing dose, with wide interindividual variability (CV% up to 140%). The mean C max (ng/mL...Continue Reading

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Citations

Mar 20, 2015·Clinical Pharmacology and Therapeutics·Aia AhmedMgm Olde Rikkert
May 4, 2017·Expert Opinion on Drug Metabolism & Toxicology·Emily ReeveSarah N Hilmer
Oct 28, 2017·Clinical Psychopharmacology and Neuroscience : the Official Scientific Journal of the Korean College of Neuropsychopharmacology·Keane LimJimmy Lee
Mar 19, 2020·Clinical Gerontologist·Thammanard CharernboonThitipon Supasitthumrong
Jun 3, 2020·The Annals of Pharmacotherapy·Shannon IngletWhitney Mortensen
Sep 15, 2016·Journal of Psychopharmacology·Geke Ah van den ElsenMarjolein A van der Marck
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Feb 2, 2019·European Archives of Psychiatry and Clinical Neuroscience·Eva HochOliver Pogarell
Nov 7, 2019·Journal of Clinical Medicine·Ran AbuhasiraVictor Novack
Sep 20, 2020·Addictive Behaviors·Evan A WinigerL Cinnamon Bidwell
Jan 28, 2021·Expert Review of Clinical Pharmacology·Awais AftabMartha Sajatovic
Oct 21, 2020·Expert Opinion on Drug Metabolism & Toxicology·Dorsa MaherEmily Reeve
Nov 25, 2020·International Journal of Molecular Sciences·Sandra Sánchez-SarasúaJuan Carlos Ledesma
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Jul 3, 2021·Biology·Giulia AbateSimone Tambaro
Sep 18, 2021·The Cochrane Database of Systematic Reviews·Dina Bosnjak KuharicLivia Puljak

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Clinical Trials Mentioned

NCT01302340

Software Mentioned

Phoenix WinNonlin
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