Cesamet (nabilone) / Bausch Health, Viatris - LARVOL DELTA

Medication Development for Cannabis Use Disorder and Cannabis Withdrawal (CPDD 2025) - "First, a 12-week randomized controlled trial found significant reductions in cannabis use outcomes with varenicline treatment combined with medical management compared to placebo treatment...Second, treatment-seeking youth with CUD were randomized to receive a double-blind 12-week course of oral N-acetylcysteine (NAC) 1200 mg or placebo twice daily; all received weekly medical management and brief behavioral counseling. No difference in cannabis use reduction or cessation outcomes was noted between participants in the NAC and placebo groups, suggesting that NAC is not efficacious for youth CUD when not paired with contingency management. Finally, a phase 2 randomized multi-center double-blind, multiple dose, placebo-controlled clinical trial demonstrated that a unique 34-day taper/titration with nabilone and gabapentin (PP-01) significantly mitigated withdrawal symptoms and decreased cannabis use compared to placebo in adults with moderate to severe CUD seeking to..."

Substance Abuse

Predictors of Cannabis Abstinence in a Clinical Trial (CPDD 2025) - "Adult participants with moderate/severe CUD, a history of withdrawal, and seeking to discontinue cannabis were randomized to tapering/titrating doses of PP-01 high dose (HD), PP-01 low dose, nabilone, gabapentin, or placebo. More PP-01 HD participants reported no cannabis use compared to placebo. Early mitigation of withdrawal symptoms was predictive of cannabis abstinence including during the 2-week post-treatment period in this Phase 2 trial. Treating cannabis withdrawal symptoms may help to minimize recidivism."

Clinical

Cannabinoids for Medical Purposes in Children: A Living Systematic Review. (PubMed, Acta Paediatr) - "These findings will continue to be updated to inform practice and reveal knowledge gaps for future research."

Journal • Review • Autism Spectrum Disorder • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Epilepsy • Genetic Disorders • Oncology • Pain

The effect of a synthetic cannabinoid agonist (nabilone) on unimodal tactile illusion correlates with a psychometric scores in healthy volunteers. (PubMed, Sci Rep) - "However, there were associations between the overall psychometric scores and funneling under the strongest (0 ms delay) illusion condition, which is dependent on the drug condition (nabilone ρ = 0.45, p = 0.028). To conclude, unlike the effects of dexamphetamine, low activation of the cannabinoid system decreases the illusory perception of funneling, with narrowing spatial BWs."

Clinical • Journal • CNS Disorders • Psychiatry

Feasibility and Tolerability of Nabilone for the Treatment of Obesity: A Randomized Controlled Pilot Trial. (PubMed, Cannabis Cannabinoid Res) - " This pilot trial found poor tolerability of nabilone pharmacotherapy (especially at 6 mg/day) for adults with obesity who had not used any cannabinoid drugs for 6 months prior to enrolment. Preliminary results suggest a possible impact of nabilone on the gut microbiome."

Clinical • Journal • Genetic Disorders • Obesity

AgiNab: Nabilone for Agitation in Frontotemporal Dementia (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Simon Ducharme, MD | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ Apr 2026

Enrollment open • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration

Pharmacological Treatment of Neuropsychiatric Symptoms in Huntington's Disease: A Systematic Review. (PubMed, Mov Disord Clin Pract) - "We conclude that although NPS in HD are common, hardly any clinical trials have addressed their treatment. As a result, convincing evidence that could guide clinical practice is lacking. More focused, and larger, multicenter trials focusing on NPS are urgently needed to generate the knowledge necessary to support the development of evidence-based clinical treatment guidelines."

Journal • Review • CNS Disorders • Depression • Huntington's Disease • Mood Disorders • Movement Disorders • Psychiatry

N-AND: Clinical Trial of Nabilone for Aggression in Adults with Intellectual and Developmental Disabilities (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Hsiang-Yuan Lin | Trial completion date: Mar 2024 ➔ Dec 2025 | Trial primary completion date: Mar 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • CNS Disorders • Developmental Disorders • Mental Retardation • Psychiatry

Perceived Risk of Medical Cannabis and Prescribed Cannabinoids for Chronic Pain: A Cross-Sectional Study Among Quebec Clinicians. (PubMed, Cannabis) - "They were asked to rate the risk of adverse effects associated with medical cannabis (e.g., smoke, or oil) and prescribed cannabinoids (e.g., nabilone) on a scale of 0 to 10 (0: no risk, 10: very high risk), respectively...No sex differences were found in terms of perceived risk. Considering the clinician's experience provide insights on cannabis risk as these professionals are at the forefront of patient care when they encounter adverse effects."

Journal • Observational data • Pain

Patterns of Nabilone Prescriptions in Canadian Long-Term Care Facilities. (PubMed, Can J Aging) - "Our results provide valuable information regarding the increasing use of synthetic cannabinoids in LTC. The implications for clinical practice and policy decision-makers are discussed."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Depression • Mood Disorders • Pain • Psychiatry

PSYCHEDELICS AND CANNABINOIDS IN THE TREATMENT OF OCD: A REVIEW OF THE CURRENT EVIDENCE (WPA 2024) - "Case reports of treatment augmentation with dronabinol (tetrahydrocannabinol, THC), a partial CB1 and CB2 receptor agonist, report improvement on the Y-BOCS in patients with TR-OCD (level 4) [558, 559]. A small RCT (n=11) in moderate-to-severe OCD reported that nabilone (a synthetic form of THC) as an add-on to exposure and response prevention (ERP) therapy was superior to nabilone alone (level 4) [560]...Further research is needed to understand safety, tolerability, and efficacy of using psilocybin in patients with TR-OCD. Due to safety concerns about using psilocybin outside of a structured treatment setting, we are unable to make a recommendation at this time."

Review • CNS Disorders

Controlled Inhalation of Tetrahydrocannabinol-Predominant Cannabis Flos Mitigates Severity of Post-Traumatic Stress Disorder Symptoms and Improves Quality of Sleep and General Mood in Cannabis-Experienced UK Civilians: A Real-World, Observational Study. (PubMed, Med Cannabis Cannabinoids) - "Evidence suggests that cannabinoid agonists such as nabilone and tetrahydrocannabinol (THC) may alleviate PTSD symptoms...Inhalation of THC is well tolerated and useful for managing symptoms of PTSD in cannabis-experienced individuals. However, further research is needed to evaluate the long-term safety and outcomes of controlled inhalation of CBMP in patients naïve to cannabis."

Journal • Observational data • Real-world • Real-world evidence • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

DIalysis Symptom COntrol-Pruritus Outcome Trial (DISCO-POT): A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Crossover Trial (KIDNEY WEEK 2024) - P3 | "This small trial detected no effect of nabilone on uremic pruritus compared to placebo. (ClinicalTrials.gov NCT05180968)"

Clinical • Late-breaking abstract • Dermatology • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Pruritus • Renal Disease

Heterogeneity of treatment response: A post hoc analysis of clinical factors from a randomized placebo-controlled trial of nabilone for agitation in Alzheimer's disease (CTAD 2024) - No abstract available

Clinical • Heterogeneity • Late-breaking abstract • Retrospective data • Alzheimer's Disease • CNS Disorders

Exploring Novel Pharmacotherapy Candidates for Cannabis Use Disorder: Uncovering Promising Agents on the Horizon by Mechanism of Action. (PubMed, Drugs) - "Pharmacotherapies for CUD are categorized based on compound targets (e.g., cannabinoid receptor 1 [CB1] agonists such as nabilone, serotonergic compounds such as bupropion, GABAergic compounds such as zolpidem) and outcomes are organized by predetermined withdrawal symptoms, cannabis craving, and cannabis relapse/use. Priority populations such as females, certain racial/ethnic groups, and age groups experience a different course of CUD progression, symptoms, and drug effects that are important to consider when evaluating outcomes related to CUD. Possible explanations for these disparities are explored, along with the clinical trials that explore these demographics in treating CUD with pharmacotherapies."

Journal • Review • Substance Abuse

Cannabinoids Used for Medical Purposes in Children and Adolescents: A Systematic Review and Meta-Analysis. (PubMed, JAMA Pediatr) - "Interventions included purified cannabidiol (11 [47.8%]), nabilone (4 [17.4%]), tetrahydrocannabinol (3 [13.0%]), cannabis herbal extract (3 [13.0%]), and dexanabinol (2 [8.7%]). In this systematic review and meta-analysis, cannabinoids used for medical purposes in children and adolescents in RCTs were associated with an increased risk of adverse events. The findings suggest that long-term safety studies, including those exploring cannabinoid-related drug interactions and tools that improve adverse event reporting, are needed."

Clinical • Journal • Retrospective data • Review • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Epilepsy

Multi-modal and bi-directional effects of a synthetic Δ9-Tetrahydrocannabinol (THC) analogue, Nabilone, on spatio-temporal binding windows: Evidence from the projected hand illusion. (PubMed, PLoS One) - "NAB widened the STBW in some but narrowed it in others as a function of space and delay. No associations were found between agency and embodiment."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Comparative Safety Analysis of Nabilone Versus Opioids: A Population-Based Cohort Study. (PubMed, J Gen Intern Med) - "While usage of nabilone relative to opioids was associated with reduced rates of pneumonia, falls or fractures, and all-cause mortality, it was simultaneously associated with an increased rate of adverse mental health outcomes. This picture of mixed safety results raises concerns with the policy approach of broadly substituting use of opioids with nabilone."

Journal • Behavior Disorders • Infectious Disease • Mental Retardation • Musculoskeletal Diseases • Oncology • Pain • Pneumonia • Psychiatry • Respiratory Diseases

The effects of nabilone (a synthetic cannabinoid agonist) on funneling illusion and working memory (IASP 2024) - "Low activation of the cannabinoid system decreases the illusory perception of funnelling. However, nabilone increased ratings on measures of PLE suggesting that nabilone may render opposite effects on psychosis and objective illusory perception. Furthermore, low doses of synthetic cannabinoid impaired WM indicating that exogenous activation of the cannabinoid system influences cognitive performance."

CNS Disorders • Neuralgia • Pain • Psychiatry

NHS-Reimbursed Cannabis Flowers for Cancer Palliative Care and the Management of Chemotherapy-Induced Nausea and Vomiting: An Autobiographical Case Report. (PubMed, Cureus) - "He received FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy and underwent an emergency Hartmann's procedure with subsequent second-line FOLFOX (folinic acid, fluorouracil, and oxaliplatin) chemotherapy and lung ablation...Antiemetics metoclopramide and aprepitant demonstrated moderated efficacy. Antiemetics ondansetron, levomepromazine, and nabilone were associated with intolerable side effects. Inhalation of THC-predominant cannabis flowers in association with standard medication improved CINV, anxiety, sleep quality, appetite, overall mood, and quality of life. Our results add to the available evidence suggesting that medicinal cannabis flowers may offer valuable support in cancer palliative care integrated with standard-of-care oncology treatment. The successful individual funding request in this case demonstrates a pathway for other patients to gain access to these treatments, advocating for broader awareness and integration..."

CINV • Journal • Chemotherapy-Induced Nausea and Vomiting • Mood Disorders • Non Small Cell Lung Cancer • Oncology • Palliative care • Psychiatry

The State of Synthetic Cannabinoid Medications for the Treatment of Pain. (PubMed, CNS Drugs) - "Dronabinol and nabilone, which mimic THC signalling, have been approved by the Food and Drug Administration (FDA) for treating nausea associated with cancer chemotherapy and/or acquired immunodeficiency syndrome (AIDS). However, there is ongoing interest in these two drugs as potential analgesics for a variety of other clinical conditions, including neuropathic pain, spasticity-related pain, and nociplastic pain syndromes including fibromyalgia, osteoarthritis, and postoperative pain, among others. In this review, we highlight the signalling mechanisms of FDA-approved synthetic cannabinoids, discuss key clinical trials that investigate their analgesic potential, and illustrate challenges faced when bringing synthetic cannabinoids to the clinic."

Journal • Fibromyalgia • Human Immunodeficiency Virus • Immunology • Infectious Disease • Movement Disorders • Musculoskeletal Pain • Neuralgia • Oncology • Osteoarthritis • Pain • Rheumatology

Evaluating the Abuse Potential of Lenabasum, a Selective CB2 Cannabinoid Receptor Agonist. (PubMed, J Pharmacol Exp Ther) - "CB1 and CB2 agonists exhibit broad anti-inflammatory properties, suggesting their potential to treat inflammatory diseases...Three doses of lenabasum (20, 60, and 120mg) were compared to placebo, and nabilone (3 and 6mg)...Significance Statement This work provides evidence that in people with a history of recreational cannabis use, lenabasum was safe and well-tolerated, although it did demonstrate abuse potential. This work supports further development of lenabasum for potential therapeutic indications."

Journal • CNS Disorders • Inflammation

The potential of cannabinoids in managing cancer-related anorexia in older adults: a systematic review of the literature. (PubMed, J Nutr Health Aging) - "Cannabinoids offer promise in enhancing the quality of life for older individuals with active neoplastic disease. However, to establish comprehensive guidelines, further research with larger sample sizes is essential. Only through this approach can we fully grasp the potential and application of cannabinoids in addressing the nutritional concerns associated with neoplastic diseases."

Journal • Review • Anorexia • Geriatric Disorders • Oncology • Pain

Pharmacotherapy for sleep disturbances in post-traumatic stress disorder (PTSD): A network meta-analysis. (PubMed, Sleep Med) - "Underpowered individual comparisons and very-low to moderate confidence in effect estimates hinder the generalisability of the results. More RCTs, specifically reporting on sleep-related outcomes, are urgently needed."

Journal • Retrospective data • Review • CNS Disorders • Insomnia • Mood Disorders • Post-traumatic Stress Disorder • Sleep Disorder

Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: New York State Psychiatric Institute | N=60 ➔ 0 | Trial completion date: Jul 2026 ➔ May 2024 | Recruiting ➔ Withdrawn | Trial primary completion date: Jul 2026 ➔ May 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Mood Disorders • Obsessive-Compulsive Disorder • Psychiatry