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

NAB-IT: Nabilone for Agitation Blinded Intervention Trial (clinicaltrials.gov) - P3 | N=112 | Recruiting | Sponsor: Sunnybrook Health Sciences Centre | Trial completion date: Oct 2025 ➔ Apr 2027 | Trial primary completion date: Oct 2025 ➔ Apr 2027

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

N-AND: Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Hsiang-Yuan Lin | Recruiting ➔ Completed | N=30 ➔ 20 | Trial completion date: Dec 2025 ➔ Aug 2025 | Trial primary completion date: Dec 2025 ➔ Aug 2025

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

Assessment of clinical factors that predict response to nabilone for agitation in Alzheimer's disease: A post hoc analysis of a randomized placebo-controlled trial. (PubMed, Int Psychogeriatr) - "A reliable clinical profile of persons with AD related agitation likely to respond to nabilone may be established with additional research."

Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Pain • Psychiatry

A Combination of Low-Dose Δ9-THC and Celecoxib as a Therapeutic Strategy for Alzheimer's Disease. (PubMed, Aging Dis) - "These findings suggest that the combination of low-dose Δ9-THC and Celecoxib holds promise as an early intervention strategy for preventing AD onset or treating mild cognitive impairment (MCI). Importantly, both Δ9-THC (in the form of Dronabinol and Nabilone) and Celecoxib are FDA-approved medications already in clinical use, supporting the strong translational potential of this combination therapy and its feasibility for rapid advancement to clinical trials to assess its efficacy in preventing or delaying AD onset in humans."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Inflammation

Clinical Manifestations. (PubMed, Alzheimers Dement) - "AD patients with pain, apathy and appetite changes, and with less cognitive impairment and not on ChEIs, were most likely to benefit from nabilone. If replicated with phase 3 data, these predictors may assist in guiding clinicians on who is likely to benefit from nabilone when managing agitation."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Pain • Psychiatry

Clinical Manifestations. (PubMed, Alzheimers Dement) - "Participants with higher levels of inflammation, oxidative stress, and cholesterol metabolite were more likely to benefit from nabilone for agitation in AD. A combination of biomarkers could help in distinguishing responders and non-responders to nabilone."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation • Psychiatry • CLU • IL6

Clinical Manifestations. (PubMed, Alzheimers Dement) - "In addition to the efficacy for improving agitation shown previously, these exploratory results suggest that nabilone can also alleviate anxiety and depression symptoms in moderate-severe AD patients. The change in appetite/eating habits required further attention, as the specific changes (increase or decrease in appetite) were unclear."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Developmental Disorders • Mood Disorders • Psychiatry

Cannabis-Based Products for Chronic Pain : An Updated Systematic Review. (PubMed, Ann Intern Med) - "Among THC-only products, nabilone moderately reduced pain severity but dronabinol did not (pooled differences, -1.59 and -0.23 points, respectively). Studies are needed on long-term outcomes and other cannabis product types. Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services (PROSPERO: CRD42021229579)."

Journal • Review • Anesthesia • Neuralgia • Pain

Pain Severity Moderates Efficacy of Nabilone for Agitation in Alzheimer's Disease (CTAD 2025) - No abstract available

Clinical • Alzheimer's Disease • CNS Disorders • Pain

Therapeutic Use of Cannabis and Cannabinoids: A Review. (PubMed, JAMA) - "A meta-analysis of randomized clinical trials reported a small but significant reduction in nausea and vomiting from various causes (eg, chemotherapy, cancer) when comparing prescribed cannabinoids (eg, dronabinol, nabilone) with placebo or active comparators (eg, alizapride, chlorpromazine; standardized mean difference [SMD], -0.29 [95% CI, -0.39 to -0.18]). Clear guidance from clinicians is essential to support safe, evidence-based decision-making. Clinicians should weigh benefits against risks when engaging patients in informed discussions about cannabis or cannabinoid use."

Clinical • Journal • Anorexia • Cardiovascular • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Coronary Artery Disease • Epilepsy • General Anxiety Disorder • Heart Failure • Human Immunodeficiency Virus • Infectious Disease • Insomnia • Mood Disorders • Myocardial Infarction • Oncology • Pain • Pediatrics • Psychiatry • Schizophrenia • Sleep Disorder • Substance Abuse

Identifying a combination of biomarkers to predict treatment response to nabilone for agitation in Alzheimer's disease - an exploratory post hoc analysis. (PubMed, Neurodegener Dis Manag) - "The proportion of responders was significantly higher in T1 (91%, n = 11) compared to T2 + 3 (32%, n = 19) (Fisher's p = .002). A combination of biomarkers could help characterize responders and non-responders to nabilone."

Biomarker • Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Inflammation • CLU • IL6

CATNP: Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury (clinicaltrials.gov) - P3 | N=14 | Completed | Sponsor: Eldon Loh, MD | Recruiting ➔ Completed | N=140 ➔ 14 | Trial completion date: Dec 2026 ➔ Dec 2024

Enrollment change • Trial completion • Trial completion date • CNS Disorders • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain

The Endocannabinoid System in PTSD: Molecular Targets for Modulating Fear and Anxiety. (PubMed, Pharmacopsychiatry) - "Preliminary human trials report that nabilone alleviates trauma-related nightmares and that acute cannabinoid administration modulates amygdala reactivity to a threat...By elucidating molecular targets - including CB₁, CB₂, FAAH, and monoacylglycerol lipase - this review outlines a strategic framework for next-generation cannabinoid-based interventions. Harnessing the endocannabinoid system promises to expand the therapeutic arsenal for PTSD, offering hope for more effective and better-tolerated treatments."

Journal • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry • Substance Abuse

MDMA-assisted therapy and current treatment options for chronic, treatment-resistant, moderate or higher severity post-traumatic stress disorder: Systematic literature review. (PubMed, PLoS One) - "This systematic review suggests current treatments for PTSD are associated with heterogeneous evidence and the majority do not demonstrate sustained effects. Results from MDMA-AT showed consistent improvements in CAPS, BDI and LOD."

Journal • Review • CNS Disorders • Depression • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Letter: Nabilone for the Treatment of Obesity: still Many Hurdles to Tackle. (PubMed, Cannabis Cannabinoid Res) - No abstract available

Journal • Genetic Disorders • Obesity

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