Clin Pharmacol Drug Dev
March 2024
The substantial challenges facing high and low dose psychedelic drug development to achieve regulatory approval have been documented in the scientific literature. These limitations have not deterred drug developers and social media from repeatedly misleading patients, the public and health professionals. Developing "micro doses" of psychedelics overcomes many of the scientific and regulatory challenges of high dose psychedelics.
View Article and Find Full Text PDFObjective: Many academic centers in North America are initiating global partnerships to build physician capacity in resource-poor countries. An opportunity arose to develop a pediatric program (Ukraine Paediatric Fellowship Program, UPFP) in Ukraine, a large European country in transition from a Soviet/communist political and social system. This entailed dealing with a centralized and rigid healthcare system based on the Semashko model of the former Soviet Union.
View Article and Find Full Text PDFScientific curiosity and fascination have played a key role in human research with psychedelics along with the hope that perceptual alterations and heightened insight could benefit well-being and play a role in the treatment of various neuropsychiatric disorders. These motivations need to be tempered by a realistic assessment of the hurdles to be cleared for therapeutic use. Development of a psychedelic drug for treatment of a serious psychiatric disorder presents substantial although not insurmountable challenges.
View Article and Find Full Text PDFAll drugs with central nervous system activity must undergo an assessment of their abuse potential, and these data must be included in a New Drug Application. Part of this assessment is an analysis of treatment-emergent adverse events that occur during clinical development. Using an iterative consensus strategy, we evaluated and grouped an available list of 213 flag terms for abuse potential from the Food and Drug Administration, into categories and assessed the relevance of the terms to primary abuse behavior.
View Article and Find Full Text PDFPsychoactive drugs that increase alertness, attention and concentration and energy, while also elevating mood, heart rate and blood pressure are referred to as stimulants. Despite some overlapping similarities, stimulants cannot be easily categorized by their chemical structure, mechanism of action, receptor binding profile, effects on monoamine uptake, behavioral pharmacology (e.g.
View Article and Find Full Text PDFThe overarching goal of this event-related potential (ERP) study was to examine the effects of scopolamine on the dynamics of brain network activation using a novel ERP network analysis method known as Brain Network Activation (BNA). BNA was used for extracting group-common stimulus-activated network patterns elicited to matching probe stimuli in the context of a delayed matching-to-sample task following placebo and scopolamine treatments administered to healthy participants. The BNA extracted networks revealed the existence of two pathophysiological mechanisms following scopolamine, disconnection, and compensation.
View Article and Find Full Text PDFObjective: This study aimed to evaluate the abuse potential and cognitive effects of nabiximols (Sativex, GW Pharma Ltd. Salisbury, UK), an oromucosal spray primarily containing delta‐9‐tetrahydrocannabinol (THC) and cannabidiol (CBD).
Methods: This was a single‐dose, randomized, double‐blind, crossover study comparing nabiximols (4, 8, and 16 consecutive sprays: 10.
The results of two single-blind studies conducted to evaluate the cognitive and psychomotor effects of eslicarbazepine acetate and oxcarbazepine following single and repeated administration in healthy volunteers are reported. The cognitive and psychomotor evaluation consisted of several computerized and paper-and-pencil measures. Eslicarbazepine acetate and oxcarbazepine had similar overall cognitive profiles and did not cause clinically relevant cognitive impairment.
View Article and Find Full Text PDFIntroduction: While prescription opioids can improve quality of life through pain relief they are susceptible to misuse. This field study characterizes the relative susceptibility and attractiveness of a new analgesic patch, with fentanyl embedded in a matrix material, compared to other opioid dose formulations.
Methods: Recreational opioid abusers (N = 42; 31 male, 1 female)from three Canadian sites participated in structured interviews.
Allopregnanolone (ALLO) and pregnanolone (PREG), the 3alpha-reduced metabolites of progesterone (PROG), are potent modulators of gamma-aminobutyric acid type A receptors that may function as endogenous anxiolytics. They are purported to be involved in the etiology or expression of clinical depression. In the present study we quantified ALLO and PREG, as well as PROG, 5alpha-dihydroprogesterone (5alpha-DHP), 5beta-dihydroprogesterone (5beta-DHP), epiallopregnanolone and pregnenolone (PREGNEN), in plasma from healthy women at five time points during pregnancy and the postpartum period.
View Article and Find Full Text PDFPsychopharmacology (Berl)
September 2004
While serotonin 5HT2-receptors have been implicated in the etiology and pharmacological treatment of a number of neuropsychiatric conditions, there are few potent and specific agents available for use in human clinical studies. EMD 281014 is a highly specific 5HT2-receptor antagonist that is currently under development. To find optimal doses for early clinical studies, we conducted a PET study using [18F]setoperone in nine healthy subjects scanned at baseline and following the administration of 1, 3, and 7 mg EMD 281014.
View Article and Find Full Text PDFCan J Clin Pharmacol
January 2003
Objectives: Alcohol dependence is a prevalent psychiatric disorder affecting approximately 12% of the adult population at some point in their lifetime. Psychosocial treatments are associated with only modest success rates. The first Canadian clinical trial with naltrexone, an opiate antagonist, was conducted to evaluate its safety and usefulness as an adjunctive treatment in the management of alcohol dependence.
View Article and Find Full Text PDFCodeine is O-demethylated by cytochrome P450 2D6 (CYP2D6) to form the more potent drug morphine, accounting for much of codeine's analgesic and dependence-producing properties. Because morphine production can be decreased by inhibition of CYP2D6, the authors hypothesized that CYP2D6 inhibition could be used to treat codeine dependence. A randomized, double-blind, placebo-controlled trial was conducted.
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