Registered studies, protocols and reported results
Studies
Clinical study protocols and source-reported registry results, preserved locally.
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Registered studies, protocols and reported results
Clinical study protocols and source-reported registry results, preserved locally.
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Registered studies, protocols and reported results
Study registrations describe protocols. Results are shown only when the registry supplied a Results section; local links are not efficacy claims.
256 exact matches
Snapshot 14/09/2026Dysregulation in stress responsivity is a growing psychiatry-transdiagnostic fundamental phenomenon, with limited therapeutic strategies. With the legalization of medical and recreational cannabis, many people consume cannabidiol (CBD; a nonintoxicating cannabinoid) to alleviate stress response, without the benefit of scientific guidance. To address this gap, the investigators propose a rigorous translational neuroscience study in a clinical high-risk population to define the roles of CBD in stress response with mechanisms of mesocorticolimbic-network function and hierarchy, neurometabolic, endocrine, and behavior, building upon convergent evidence from animal models and human evidence from our laboratories. Dysregulation in stress responsivity, encompassing mesocorticolimbic and hypothalamus-pituitary-adrenal-axis pathways, is a psychiatry-transdiagnostic fundamental phenomenon. Current anxiolytic pharmacotherapies are limited in their efficacy and could cause dependence, low tolerance, and sexual dysfunction. With the growing number of vulnerable individuals suffering from stress-related disorders in society, there is an urgent need for novel therapeutic modalities particularly for early intervention and to improve treatments of stress-related disorders. Convergent evidence from animal and human studies of cannabidiol (CBD), a nonintoxicating and well-tolerated cannabinoid, has shown to have anxiolytic effects on stress reactivity especially in responses to environmental stimuli (cue-sensitized states). CBD has multiple pharmacological targets acting as an allosteric modulator of cannabinoid receptors and a glutamate-modulating agent. Despite recent surges in the use of CBD to alleviate stress symptoms, its pathophysiological mechanisms in human stress-system pathways remain largely unknown. Understanding the mechanisms of action of CBD in stress responsivity may lead to novel therapeutic strategies for stress-related disorders. Based on its safety and the growing evidence of CBD to reduce cue-induced reactivity, the investigators propose to evaluate the mechanisms underlying CBD's roles in stress response in a clinical high-risk population of young adults with early life adversity (ELA), known to exhibit this phenotype. This proposal leverages the investigators clinical and research expertise with high-risk populations with ELA and other investigators established experience with CBD clinical trials. Specifically, the researchers neuroimaging study demonstrated prefrontal neuroanatomical impairments associated with enhanced clinical symptomatology in individuals with ELA. In relation to CBD, the researchers have shown in healthy individuals that oral CBD is safe and well tolerated. The researchers have demonstrated that CBD reduced cue-induced anxiety in individuals with psychopathology and that the effects persisted even when the cannabinoid was no longer detectable in the body. Moreover, in the randomized, double-blind placebo-controlled trial the researchers not only replicated the original findings that CBD decreased cue-induced anxiety but also showed that it concomitantly reduced physiological stress responsivity marks (cortisol and heart rate). Importantly, its protracted effects were again evident a week after the last administration. Notably, the researchers pharmacokinetic trial replicated the previous findings showing rapid bioavailability in oral CBD dose (400mg) known to have behavioral efficacy. The investigators hypotheses are that during stress responsivity CBD will: 1) downregulate the neural reactivity in mesocorticolimbic regions; 2) reduce influence of limbic regions within the stress network dependency hierarchy; 3) reduce neuronal viability in mesocorticolimbic regions; and 4) decrease endocrine and behavioral hyperreactivity, in clinical high-risk individuals. This study of unmedicated young adult males and females (N=160) with ELA, will examine neurobiological mechanisms of stress as manipulated by acute CBD vs. placebo (400mg, oral; using a double-blind, randomized, placebo-control design), as well as determine the relationship between CBD-sustained (7-day) change and endocrine and behavioral acute stress responsivity.
This clinical trial is being done to better understand how daily treatment with Tetrahydrocannabinol (THC), Cannabidiol (CBD), or the combination of CBD plus THC affects knee osteoarthritis pain and other related symptoms. Consented participants will have a screening period and visit (up to 30 days to treatment start). If participants pass the screening phase, they will be randomly assigned to take one of the investigational study drugs. For this study, participants will not know when or if they are taking CBD, THC, THC plus CBD, and when or if taking placebo. Clinical pain will be assessed at multiple times throughout the study, and eligibility will be re-assessed at two weeks into the treatment period. It is possible that subjects will not be able to participate in the study after 14 days of of treatment. The treatment period will take approximately 16 weeks and then a follow-up period for approximately 2 weeks. In addition to treatment, participants will have clinical assessments, blood draws, questionnaires, daily pain diaries, sensory testing, as well as have functional connectivity magnetic resonance imaging (fcMRI). The study hypothesizes that: * CBD alone will exert a peripheral anti-inflammatory effect by decreasing levels of Interleukin (IL)-6 * THC alone will modify central nervous system (CNS) pain via decreasing insula to Default Mode Network (DMN) connectivity * CBD plus THC will do both.
Open study recordThis will be a proof-of-concept, single arm study with a maximum of 20 patients to evaluate preliminary analgesic efficacy and safety of Trichomylin® in patients with advanced cancer (male and female) who suffer from moderate to severe chronic pain and who are taking a stable dose of long-acting opioid therapy for at least 1 week prior to screening. This study will consist of a screening visit, treatment, and safety follow-up period. There will be an initial patient determined titration phase, using escalated doses of Investigational Product, to reach a dose that achieves symptom relief with tolerable side effects. Each capsule of Trichomylin® contains a fixed ratio of 5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene. Participants can titrate up to a maximum of 2 capsules twice daily (total of 4 capsules). This will be followed by a 5 day assessment period of the stable dose determined in collaboration with clinicians.
Open study recordThis is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults.
Open study recordThe overall strategy is to recruit veterans with PTSD who report minimal current cannabis use but are interested in or considering therapeutic cannabis to manage mental health symptoms (anxiety, depression, PTSD and/or suicidality). The information gained from this study could lead to the development of new treatments for persons who suffer from post-traumatic stress disorder and maintain better mental health. The total time commitment estimated per participant is 20 study visits. This is approximated below: Visit 1: Screening Consent and Screening Assessments: During this visit the potential participant will learn about the study procedures and sign the screening informed consent documents, then complete screening measures which will include a clinical interview (i.e., assessments of PTSD and other psychiatric diagnoses, suicidality, medical history, etc.), a physical examination, and various questionnaires. At this time, they will collect blood, urine, breathalyzer and saliva samples. Visit 2: Study consent and Baseline Assessments: During this visit the participant will be asked to read the study informed consent form and will have an opportunity to have any questions answered before agreeing to participate in the study. Particular attention will be given to reviewing required procedures and possible side effects of the drugs (THC and CBD) with participants. Visit 3: Pre-Treatment Behavioral Tests and Magnetic Resonance (MR) Scan: During this visit the participant will complete several computer tasks, and the study staff will be measuring reaction time and psychophysiological measures. The tasks that the participant will perform will show three different images and an aversive stimulus (e.g. which will be a mild electric shock to the ankle paired with a snake hissing sound of an animated snake) may follow one image most of the time, while the other images may never be followed by the aversive cue. The participant will need to try to predict whether the aversive cue will occur or not based on which image is shown and will be asked to repeatedly rate on a scale how likely it is that he or she thinks an aversive cue will occur after each image. Lastly, during the session the participant will also be asked to report his or her level of anxiety on a scale from 0 to 100. Visit 4: Pre-Treatment Behavioral Tests with MR Scan: This visit will be very similar to Visit 4. Participants will participate in the same type of task inside the MR scanner, while the study staff measures reaction time and psychophysiological responding and brain activation. Participants will view the same images he or she did previously and may experience the same aversive stimulus as during Visit 3. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and will also be asked to report their level of anxiety on a scale from 0 to 100. Visit 5\&6: Prolonged Exposure (PE) Sessions 1 \& 2: These sessions will consist of psychoeducation that includes discussion or reactions to trauma, treatment rationale, breathing retraining, and review of the Subjective Units of Distress Scale (SUDS) to assess level of distress from 0 to 100 (100=extreme anxiety/distress) when facing fears. One session occurs weekly across 2 weeks. Visit 7-10: Prolonged Exposure (PE) Sessions 3-6: These sessions will consist of repeated exposures to trauma memories (imaginal exposure) and avoided situations (in vivo exposure). As is standard, patients will also practice exposures (e.g., listen to tapes of imaginal exposure, carry out in vivo exposure) outside of PE sessions as "homework". At exposure-focused sessions either cannabis or placebo (PBO) will be administered just before the session. One session occurs weekly across 8 weeks. Visit 11: Prolonged Exposure (PE) Session 7: This visit is similar to the ones above, but it will include a mid-treatment assessment and there won't be any cannabis or placebo administration. Visit 12-14: Prolonged Exposure (PE) Sessions 8-10: These sessions will consist of repeated exposures to trauma memories (imaginal exposure) and avoided situations (in vivo exposure). As is standard, patients will also practice exposures (e.g., listen to tapes of imaginal exposure, carry out in vivo exposure) outside of PE sessions as "homework". One session occurs weekly across 8 weeks. Visit 15: Post-Treatment Assessments: This visit will include a review of therapeutic gains, relapse prevention, and assessments. Visit 16: Post-Treatment Behavioral Tests and MR Scan: This visit will be very similar to Visit 3. Participants will participate in the same type of task inside the MR scanner, while the study staff measures reaction time and psychophysiological responding and brain activation. Participants will view the same images he or she did previously and may experience the same aversive stimulus as during Visit 3. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and will also be asked to report their level of anxiety on a scale from 0 to 100. Visit 17: Post- Treatment Behavioral Tests and MR Scan: This visit will be very similar to Visit 4. Participants will participate in the same type of task inside the MR scanner, while the study staff measures reaction time and psychophysiological responding and brain activation. Participants will view the same images he or she did previously and may experience the same aversive stimulus as during Visit 5. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and will also be asked to report their level of anxiety on a scale from 0 to 100. Visit 18: 3-Month Follow-Up Treatment Assessment: This session is similar to Visit 15 and will include review of therapeutic gains, relapse prevention, and assessments. Visit 19: 6-Month Follow-Up Treatment Assessment: This session is similar to Visit 18 and will include review of therapeutic gains, relapse prevention, and assessments. Visit 20: 9-Month Follow-Up Treatment Assessment: This session is similar to Visit 19 and will include review of therapeutic gains, relapse prevention, and assessments.
Open study recordThis study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.
Open study recordResearch aim: To determine how cannabidiol suppositories might reduce sexual pain during intimacy. Outcomes are also hoped to increase sexual functioning, well-being, and quality of life. Research intention: If cannabidiol suppository intervention reduces sexual pain and increases general well-being, then this research would be repeated on a larger scale, targeting psychosexual services. A brief overview of the intervention: Quantitatively, randomisation of cannabidiol suppositories will be into dose-specific groups. The intervention will be delivered over a period of one month, with follow-up scheduled at 12 weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study. Sexual pain is a constellation of biopsychosocial disorders which affects men, women and their partners. Cannabidiol is one of approximately 100 cannabinoids found in cannabis, alongside tetrahydrocannabinol. Cannabidiol is non-intoxicating and regarded as a safe product to use. Cannabidiol has many applications, including in sexual health. Two studies have examined cannabidiol suppositories for supporting sexual function and reducing sexual pain. In both studies, outcomes suggested the pain relieving qualities of cannabidiol oil for both men and women. This research aims to establish the effectiveness of varied doses of cannabidiol oil to minimise sexual pain and increase well-being. This research is a preliminary study looking at how cannabidiol suppositories aim to reduce pain and support sexual function, wellbeing and quality of life among those experiencing sexual discomfort or pain during intercourse or masturbation. There will be four groups, where cannabidiol will be randomised to dose-specific groups, approximately 30, 50, and 100mg, under the guidance of a medical practitioner. There will also be a care as usual group. It is hypothesised that: Higher levels of sexual functioning, quality of life and wellbeing with lower levels of sexual pain will be reported among those using cannabidiol suppositories at the follow-up after intervention compared to care as usual group. It is further hypothesised that higher doses of cannabidiol suppositories will have higher levels of sexual pain-reducing outcomes.
Open study recordThis research study is investigating use of a single dose of cannabidiol (CBD) to help manage anticipatory anxiety in participants with advanced breast cancer poised to undergo computed tomography (CT) or positron emission tomography (PET) to assess tumor burden. The name of the study drug(s) are: \- Cannabidiol (CBD) This is a randomized, double-blind, placebo-controlled Phase II trial of a single dose of CBD for acute anticipatory anxiety in patients with advanced breast cancer undergoing computed tomography (CT) or positron emission tomography (PET) to assess tumor burden. The research study investigates use of CBD to manage anxiety prior to an oncologic imaging scan. CBD is a component of the cannabis sativa (marijuana) plant and of hemp. Studies of CBD have led to its approval by the Food and Drug Administration for certain childhood seizure disorders. Researchers have also been studying the use of CBD to manage anxiety and pain. This study is designed to learn if the drug can help reduce anxiety and can safely be given to participants with advanced breast cancer who are scheduled for a CT or PET scan. * After screening procedures confirm participation in the research study, participants will be "randomized" into one of two study groups: one group will receive CBD, the other group will receive a placebo of flavored corn syrup. * Randomization means that participants are put into a group by chance. Neither the participant nor the research team will choose participant group assignment. * Participants will have a 66% chance of receiving a single dose of CBD. * Participants will have a 33% chance of receiving a single dose of placebo. * On the day of treatment, participants will complete questionnaires before and after receiving a single dose of CBD or placebo then undergo computed tomography (CT) scan or positron emission tomography (PET). Participants will be contacted by phone approximately a week later and interviewed about study drug consumption and the CT/PET scan experience. This study is supported by funding from the Hans and Mavis Lopater Foundation. Approximately 50 people are anticipated to take part in this study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved CBD to manage anxiety but it has been approved for use in children with some seizure disorders.
Open study recordCannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) has been shown to reduce alcohol withdrawal symptoms in laboratory animals. In people without alcohol use disorder (AUD), CBD has been show to be effective in reducing anxiety, sleep problems, and seizures; all of these are common symptoms of alcohol withdrawal. This randomized placebo-controlled clinical trial will evaluate the potential of CBD to improve alcohol withdrawal symptoms and reduce craving during acute abstinence among individuals with moderate-to-severe AUD. Adult participants with moderate-to-severe AUD will be admitted to an inpatient research unit at the Johns Hopkins Hospital for a 5-day, 4-night stay that includes alcohol abstinence with management of their alcohol withdrawal. In addition to standard care, participants will receive CBD or placebo (no CBD), complete assessments of withdrawal, sleep quality and provide breath and blood samples. Alcohol withdrawal during acute abstinence represents a major health threat to millions of individuals struggling with alcohol use disorder (AUD): it has been associated with complications in patients admitted for medically supervised withdrawal including seizures and delirium tremens (the latter of which can be fatal if not managed appropriately) and can interfere with treatment efforts. Benzodiazepines, such as lorazepam (Ativan) represent the first-line treatments for control of alcohol withdrawal, yet higher doses of benzodiazepines required to manage more complicated withdrawal cases increase risk of respiratory depression and delirium. Furthermore, a growing frequency of benzodiazepine shortages (at least 20 shortages within the previous ten years lasting a median of 244 days) necessitates a need for alternative and adjunctive medications. Preclinical animal trials involving cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) have shown its use is associated with statistically significant reductions in withdrawal symptoms and there is evidence in non-AUD populations that CBD is effective in reducing anxiety, insomnia, and seizures, which are all symptoms of alcohol withdrawal. The capacity for CBD to enhance the effect of the inhibitory neurotransmitter GABA in a manner akin to benzodiazepines has also been demonstrated. Collectively this information suggests that CBD could alleviate signs and symptoms of alcohol withdrawal, and subsequently reduce the need for adjunctive benzodiazepines. This randomized placebo-controlled clinical trial will enroll adults with moderate-to-severe AUD who will be admitted to an inpatient research unit at the Johns Hopkins Hospital for management of their alcohol withdrawal. Enrolled participants with a history of alcohol withdrawal symptoms will be randomized to receive an oral formulation of either placebo or one of two CBD doses (10 mg/kg or 20 mg/kg). These doses have been well-studied and tolerated in prior studies and clinical trials for other disorders. Alcohol withdrawal symptoms, as defined by Diagnostic and Statistical Manual (DSM-5) criteria, will be assessed by nursing administration of the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) and participant completion of the Alcohol Withdrawal Symptom Checklist (AWSC). The CIWA-Ar scale will be used to guide the administration of symptom-triggered lorazepam (trade name Ativan) for all participants. As insomnia is a DSM-5 criterion for alcohol withdrawal, sleep quality will be assessed by completion of the Consensus Sleep Diary (CSD) and wrist actigraphy. Last, since cravings correlate closely with withdrawal symptoms and CBD has been observed to reduce craving for other substances, we will explore CBD's impact on alcohol craving by having participants complete the Alcohol Urge Questionnaire throughout the study. In short, the goals of this study will be to (1) determine the effect of CBD on physiologic and subjective symptoms of alcohol withdrawal, (2) determine the capacity of CBD to improve insomnia and disordered sleep during withdrawal, and (3) determine if CBD can attenuate alcohol cravings during acute abstinence. Results from this study can help inform the possible use of CBD as a novel adjunct treatment for alcohol withdrawal and cravings that may reduce benzodiazepine need for alcohol withdrawal treatment. If CBD is shown to be effective, this line of work also points to the potential of the endogenous cannabinoid system playing a mechanistic role in alcohol's withdrawal symptoms. Finally, this study could provide further insights into the efficacy of CBD as a sleep agent for participants with alcohol withdrawal and lay the groundwork for subsequent studies exploring CBD's use in the treatment of alcohol withdrawal in an outpatient setting.
Open study recordThis outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.
Open study recordThe purpose of this study is to test whether a single-dose of Epidiolex (cannabidiol) is associated with reduced psychological, physiological, and neuroimaging measures of anxiety in people diagnosed with social anxiety disorder (SAD). Using a randomized, double-blind, placebo-controlled, parallel-group study design, this scientific investigation will examine the effect of 3 milliliters (mL) of Epidiolex (100mg cannabidiol/mL) on behavioral, physiological, and neuroimaging measures of anxiety in subjects diagnosed with SAD. The study will enroll 50 subjects with SAD who will be randomized in a double-blind manner to receive either Epidiolex or placebo before experiencing the Trier Social Stress Test (TSST), the gold-standard for ethically inducing stress in a controlled laboratory setting. Following the TSST, neuroimaging measures of emotional processing and self-referential processing will be acquired using functional magnetic resonance imaging (fMRI). This study will be conducted primarily at Massachusetts Institute of Technology with research and clinical support from Massachusetts General Hospital.
Open study recordThe goal of this clinical trial is to evaluate the effects of cannabidiol in patients with end-stage metastatic castration-resistant prostate cancer (mCRPC). The primary objective is to determine whether cannabidiol (CBD) treatment can reduce the need for opioids in patients with end-stage mCRPC. Additionally, the study will assess a range of clinical endpoints in patients with end-stage mCRPC, including: 1. The efficacy of CBD treatment in alleviating pain 2. The efficacy of CBD treatment in reducing the need for non-opioid medications and concomitant therapies 3. The impact of CBD treatment on physical activity and quality of life 4. The anti-inflammatory and potential anti-tumor properties of CBD 5. The safety of CBD treatment Patients from Department of Urology, Aalborg University Hospital will be included. Participants will be treated with either CBD (200 mg) or placebo (0 mg) three times daily for nine weeks. At baseline, halfway and end of trial, participants will use an activity tracker and complete questionnaires regarding pain and quality of life and provide blood samples to measure inflammation and tumor activity. Also, they will complete a daily dairy regarding the study drug and intake of pain medication. Adverse events will be assessed by Common Terminology Criteria for Adverse Events.
Open study recordThis study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation. In this clinical trial, we will recruit veterans with PTSD who report using cannabis or have interest in trying cannabis for symptom relief. Veterans will be randomized into one of four different groups: THC (∆9-tetrahydrocannabinol), CBD (cannabidiol), THC+CBD, and Placebo, and undergo a 12-week treatment phase where they will be asked to smoke their assigned cannabis dose every day for 12 weeks. Participants will complete weekly questionnaires regarding their mood, behavior and drug consumption. Furthermore, there is a laboratory component that will assess cognition, fear conditioning, and other PTSD-related measures.
Open study recordItching is a common symptom encountered in general medical practice. It can cause significant discomfort, disrupt sleep, and impair patients' quality of life. Chronic pruritic skin conditions such as atopic dermatitis, nummular eczema, lichen simplex chronicus, and prurigo nodularis are frequently observed. The pathogenesis of these conditions remains incompletely understood, and effective long-term treatment options are limited. Current therapies include topical corticosteroids, topical calcineurin inhibitors, oral corticosteroids, and systemic immunosuppressants. However, these treatments are often associated with adverse effects, and the diseases tend to follow a chronic, relapsing course. Therefore, the investigators aim to investigate the efficacy and safety of topical cannabis extract in patients with chronic pruritic skin conditions.
Open study recordThe primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). Subjects will be treated in an open-label fashion with Epidiolex for two weeks. The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). OCRDs include obsessive compulsive disorder (OCD), trichotillomania, skin picking, tourettes disorder, and hoarding disorders. These disorders appear linked in terms of phenomenology and possibly biology. Fifteen subjects with OCRDs will be treated in an open-label fashion with Epidiolex (2.5 mg/kg twice daily for one week followed by 5mg/kg twice daily) for two total weeks of active treatment. The hypothesis to be tested is that Epidiolex will result in reduction in symptoms of OCRDs (improvement in symptoms will be indicated by lower scores on established outcome measures of OCRDs symptoms that have been used in prior studies).
Open study recordDespite the proliferation of cannabis and cannabinoid products in recent years, little research has been done to determine the impact of these products on womens health conditions, including endometriosis. This study is designed to assess the impact of a custom-formulated, hemp-derived, full-spectrum, high-CBD product vs. placebo on clinical symptoms and biomarkers over the course of 12 weeks of treatment in patients with endometriosis. This project will provide information that does not currently exist on the potential efficacy of a cannabinoid-based sublingual product for endometriosis. Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. Endometriosis impacts approximately 10% of women of reproductive age, an estimated 176 million individuals, and is characterized by endometrial cells growing outside of the uterus, resulting in severe pain, chronic inflammation, gastrointestinal symptoms, infertility, and often, depression and anxiety (WHO, 2023). Existing treatment options are often limited in efficacy and may result in a variety of negative side effects. Previous research has indicated that cannabinoids including cannabidiol (CBD), delta-9 tetrahydrocannabinol (THC), and a number of other cannabinoids may hold potential for treating the symptoms of endometriosis, especially the chronic pain associated with the condition. This study is a double-blind crossover clinical trial of a high-CBD product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis. Participants will complete 7 visits over 12 weeks; 4 visits will be conducted in-person at McLean Hospital in Belmont, MA, and 3 visits will be conducted remotely. Visits consist of clinical ratings, assessments of conventional medication use, quality of life measures, and providing saliva, urine, and blood samples.
Open study recordThe purpose of this research study is to compare the effects of cannabidiol (CBD), tetrahydrocannabinol (THC), or both, on sleep and pain in persons with multiple sclerosis (MS). Little is known about how CBD and/or THC may help sleep, reduce pain, or perhaps even treat pain through better sleep.
Open study recordThis study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms. Approximately one-third (33.1%) of Americans will experience an anxiety disorder at some point in their lifetime. Anxiety disorders are primarily treated with antidepressants or benzodiazepines, but unfortunately, many patients report a partial response or cannot tolerate the side effects of these medications, which include risk for abuse, cognitive impairment, and even death. The therapeutic potential of various compounds derived from the Cannabis sativa plant has generated considerable interest, particularly for managing neuropsychiatric disorders that have limited treatment options. Among these compounds, tetrahydrocannabinol (THC) and cannabidiol (CBD), have received significant attention. CBD has shown a unique pharmacological profile that lacks the potential for abuse associated with THC. Animal and small-scale human studies have demonstrated CBD's anxiolytic, antidepressant, panicolytic, and anticompulsive actions, however more research is needed to investigate the mechanisms of action and determine whether these products represent a safe and effective option for the treatment of anxiety. This study will examine the safety and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires, blood, and urine exams will be used to comprehensively monitor adverse drug events. Clinical measurements will be performed to assess changes in anxiety and sleep quality. This study will also examine whether changes in sleep disturbances precede changes in anxiety symptoms. Participants will complete a comprehensive evaluation for the assessment of relevant medical history, and concomitant medication use. This study will provide information about the dosing and safety profile of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract among individuals with anxiety. In addition, the study will provide preliminary evidence of the independent and concomitant effects of CBD on anxiety symptoms and sleep patterns among individuals with anxiety and finally will assess the feasibility and acceptability of study procedures, including dosing, adherence to the study protocols, and the assessment of anxiety symptoms and sleep disturbances measurements over time.
Open study recordPost-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance). This trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population participants are enrolled and complete baseline data collection only. All participants may complete optional functional magnetic resonance imaging (fMRI). Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance). This trial is a single-site phase II, double-blind, placebo-controlled study of Nantheia ATL5 to study symptoms of Post-Traumatic Stress Disorder (PTSD) in adults. Participants will meet criteria for PTSD using the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Assessment of Pragmatics (CAPs-5) of ≥ 27. Suicidality is assessed using the Columbia Suicide Severity Rating Scale-Revised (CSSRS-R) at all study visits. Baseline psychopharmacotherapy and/or psychotherapy must be stable (unchanged) for 4 weeks prior to enrollment and should remain unchanged during study treatment. Effects of Nantheia ATL5 on self-reported quality of life (overall and health-related); functional status measurements of personal mobility and risk, and sleep dysfunction; neurobiological biomarkers of threat response (optional functional magnetic resonance imaging: fMRI), and serum inflammatory biomarkers (hs-CRP) implicated in PTSD pathophysiology will be assessed. Efficacy and tolerability will be assessed throughout intervention. Serum pregnancy (for participants of child bearing potential), urine drug screening, complete blood count (CBC), and Comprehensive Metabolic Panel are completed at every on-site visit. Optional consent will be sought from all PTSD and healthy population participants who agree to complete the functional magnetic resonance imaging (fMRI) procedures and providing an additional sample of blood to store for future unspecified research. Baseline characteristics of participants with PTSD will be evaluated overall and relative to participants without PTSD (healthy population) during a 3-week baseline period prior to randomization \[Nantheia ATL5 or placebo (PBO)\]. Healthy population participants will complete the study at end of baseline and participants with PTSD will be randomized 1:1 to Nantheia ATL5 or placebo (PBO). Study drug dose is initiated at 400mg BID and maintained for 8 weeks. Study drug is then withdrawn, and one week later safety measures including laboratory testing, assessment of AE's and CSSRS-R are repeated.
Open study recordInsomnia is a common sleep disorder in which a person has difficulty falling asleep or staying asleep or getting good quality sleep. Consequences of insomnia include daytime sleepiness, poor memory function, decline in concentration with negative impacts on social and work activities. Although medical cannabis and cannabis products are widely used worldwide for the management of symptoms associated with insomnia, there is little clinical data available to support the efficacy or utility of CBD in the management of sleep disorders. The proposed study will assess whether nightly doses of 75mg or 150mg of an 8 week period are able to improve patient reported sleep quality when compared to a placebo.
Open study record