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The effects of cannabidiol (CBD) on cognition and symptoms in outpatients with chronic schizophrenia a randomized placebo controlled trial.

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Journal Psychopharmacology
Year 2018
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This article is included in 5 Systematic reviews Systematic reviews (5 references)

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Rationale: Preliminary evidence suggests that cannabidiol (CBD) may be effective in the treatment of neurodegenerative disorders; however, CBD has never been evaluated for the treatment of cognitive impairments associated with schizophrenia (CIAS). OBJECTIVE: This study compared the cognitive, symptomatic, and side effects of CBD versus placebo in a clinical trial. METHODS: This study was a 6-week, randomized, placebo-controlled, parallel group, fixed-dose study of oral CBD (600 mg/day) or placebo augmentation in 36 stable antipsychotic-treated patients diagnosed with chronic schizophrenia. All subjects completed the MATRICS Consensus Cognitive Battery (MCCB) at baseline and at end of 6 weeks of treatment. Psychotic symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS) at baseline and biweekly. RESULTS: There was no main effect of time or drug on MCCB Composite score, but a significant drug × time effect was observed (<i>p</i> = 0.02). Post hoc analyses revealed that only placebo-treated subjects improved over time (<i>p</i> = 0.03). There was a significant decrease in PANSS Total scores over time (<i>p</i> &lt; 0. 0001) but there was no significant drug × time interaction (<i>p</i> = 0.18). Side effects were similar between CBD and placebo, with the one exception being sedation, which was more prevalent in the CBD group. CONCLUSIONS: At the dose studied, CBD augmentation was not associated with an improvement in MCCB or PANSS scores in stable antipsychotic-treated outpatients with schizophrenia. Overall, CBD was well tolerated with no worsening of mood, suicidality, or movement side effects. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

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Effect of cannabidiol on symptoms, distress and neurophysiological abnormalities in clinical high-risk for psychosis patients: A placebocontrolled study

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Journal Effect of cannabidiol on symptoms, distress and neurophysiological abnormalities in clinical high-risk for psychosis patients: A placebocontrolled study
Year 2018
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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Background: There has been growing interest in the therapeutic potential of Cannabidiol (CBD) stemming from independent evidence that CBD has antipsychotic and anxiolytic properties in patients with mental health disorders. CBD has been found to be non-inferior to antipsychotic medication in a 4-week clinical trial in acute schizophrenia (Leweke et al 2012) and also has been found to reduce anxiety symptoms in social phobia and following public speaking. Human data also suggest that it attenuates the cognitive impairments associated with use of the main psychoactive ingredient in cannabis. However, whether CBD may be useful in relieving symptoms and distress in patients at clinical high-risk of psychosis (CHR) has never been tested. Furthermore, how the beneficial effect of CBD on psychotic and anxiety symptoms may be mediated in the brain remains unclear. The aim of the present study was to investigate whether short-term treatment with CBD was associated with preliminary evidence of therapeutic benefit and understand the neurocognitive mechanisms. Methods: We investigated the effects of short-term (21 days) treatment with CBD on psychotic and anxiety symptoms in 33 CHR patients, using a placebocontrolled, double-blind, parallel-arm design (CBD arm- 16; placebo arm- 17). In the subjects who received 21 days of treatment, we used fMRI in conjunction with a verbal memory task to assess the effect of CBD relative to placebo treatment on medial temporal and striatal function. Results: Of the 33 CHR patients recruited into the trial, 31 completed treatment for 21 days. Following 21-day treatment (intention-to-treat, last observation carried forward analysis), CBD-treated (n=16) CHR patients showed a significantly greater reduction in anxiety (p=0.02) and in distress associated with psychotic symptoms (p=0.03) and a trend (p=0.14) toward greater reduction in the severity of psychotic symptoms compared to those treated with placebo (n=17) CHR patients (Figure 4). In addition, CBD was tolerated as well as placebo. Consistent with our predictions, treatment with CBD (n=15) attenuated the engagement during verbal encoding of the parahippocampal cortex, but increased activation in the putamen in CHR patients. A similar pattern of activation was evident during verbal recall, with CBD treatment associated with increased engagement in the putamen. Discussion: Results from our proof-of-concept study suggest that 3-week treatment with CBD has beneficial effects on anxiety, attenuated psychotic symptoms and the distress associated with psychotic symptoms. They also suggest that short-term treatment with CBD modulates both medial temporal and striatal function in CHR patients, regions that are critically implicated in the CHR state. Coupled with the absence of significant adverse effects associated with CBD, a particularly important issue in relation to the treatment of CHR individuals, not all of whom develop a full-blown psychotic disorder, these data indicate that long-term treatment with CBD is likely to be efficacious in CHR patients.

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Effects on Spasticity and Neuropathic Pain of an Oral Formulation of Δ9-Tetrahydrocannabinol in Patients With Progressive Multiple Sclerosis.

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Journal Clinical therapeutics
Year 2018
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This article is included in 10 Systematic reviews Systematic reviews (10 references)

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PURPOSE: The aim of the present study was to evaluate the efficacy of an oral formulation of Δ9-tetrahydrocannabinol (ECP002A) in patients with progressive multiple sclerosis (MS). METHODS: This accelerated proof-of-concept study consisted of 2 phases: a crossover challenge (dose-finding) phase and a 4-week, parallel, randomized, placebo-controlled treatment phase. Twenty-four patients with progressive MS and moderate spasticity were enrolled. During the treatment phase, biomarkers for efficacy and secondary pharmacodynamic effects were measured at baseline and after 2 and 4 weeks of treatment. Serum samples were collected to determine pharmacokinetic properties and perform population modeling. Safety and tolerability profiles were assessed based on adverse events and safety measurements. FINDINGS: Pain was significantly reduced when measured directly after administration of ECP002A in the clinic but not when measured in a daily diary. A similar pattern was observed in subjective muscle spasticity. Other clinical outcomes were not significantly different between active treatment and placebo. Cognitive testing indicated that there was no decline in cognition after 2 or 4 weeks of treatment attributable to ECP002A compared with placebo. Implications This study specifically underlines the added value of thorough investigation of pharmacokinetic and pharmacodynamic associations in the target population. Despite the complex interplay of psychoactive effects and analgesia, the current oral formulation of Δ9-tetrahydrocannabinol may play a role in the treatment of spasticity and pain associated with MS because it was well tolerated and had a stable pharmacokinetic profile.

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Cannabidiol (CBD) as an adjunctive therapy in schizophrenia: A multicenter randomized controlled trial.

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Journal American Journal of Psychiatry
Year 2018
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This article is included in 5 Systematic reviews Systematic reviews (5 references)

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OBJECTIVE: Research in both animals and humans indicates that cannabidiol (CBD) has antipsychotic properties. The authors assessed the safety and effectiveness of CBD in patients with schizophrenia. METHOD: In an exploratory double-blind parallel-group trial, patients with schizophrenia were randomized in a 1:1 ratio to receive CBD (1000 mg/day; N = 43) or placebo (N = 45) alongside their existing antipsychotic medication. Participants were assessed before and after treatment using the Positive and Negative Syndrome Scale (PANSS), the Brief Assessment of Cognition in Schizophrenia (BACS), the Global Assessment of Functioning scale (GAF), and the improvement and severity scales of the Clinical Global Impressions Scale (CGI-I and CGI-S). RESULTS: After 6 weeks of treatment, compared with the placebo group, the CBD group had lower levels of positive psychotic symptoms (PANSS: treatment difference = 21.4, 95% CI = 22.5,20.2) and were more likely to have been rated as improved (CGI-I: treatment difference = 20.5, 95% CI = 20.8, 20.1) and as not severely unwell (CGI-S: treatment difference = 20.3, 95% CI = 20.5, 0.0) by the treating clinician. Patients who received CBD also showed greater improvements that fell short of statistical significance in cognitive performance (BACS: treatment difference = 1.31, 95% CI = 20.10, 2.72) and in overall functioning (GAF: treatment difference = 3.0, 95%CI = 20.4, 6.4). CBD was well tolerated, and rates of adverse events were similar between the CBD and placebo groups. CONCLUSIONS: These findings suggest that CBD has beneficial effects in patients with schizophrenia. AsCBD’s effects do not appear to depend on dopamine receptor antagonism, this agent may represent a new class of treatment for the disorder. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

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Tetrahydrocannabinol Does Not Reduce Pain in Patients With Chronic Abdominal Pain in a Phase 2 Placebo-controlled Study.

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Journal Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
Year 2017
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This article is included in 1 Broad synthesis Broad syntheses (1 reference) 10 Systematic reviews Systematic reviews (10 references)

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BACKGROUND & AIMS: Delta-9-tetrahydrocannabinol (THC) is the most abundant cannabinoid from the plant Cannabis sativa. There is only equivocal evidence that THC has analgesic effects. We performed a phase 2 controlled trial to evaluate the analgesic efficacy, pharmacokinetics, safety, and tolerability of an oral tablet containing purified THC in patients with chronic abdominal pain. METHODS: Sixty-five patients with chronic abdominal pain for 3 months or more (numeric rating scale scores of 3 or more) after surgery or because of chronic pancreatitis were randomly assigned to groups given the THC tablet or identical matching placebos for 50-52 days. Subjects in the THC group were given the tablet first in a step-up phase (3 mg 3 times daily for 5 days and then 5 mg 3 times daily for 5 days), followed by a stable dose phase (8 mg 3 times daily until days 50-52). Preceding and during the entire study period, patients were asked to continue taking their medications (including analgesics) according to prescription. Patients reported any additional pain medications in a diary. Efficacy and safety assessments were conducted preceding medication intake (day 1), after 15 days, and at 50-52 days. Plasma samples were collected on study days 1, 15, and 50-52; mean plasma concentration curves of THC and 11-OH-THC were plotted. The primary end point was pain relief, which was measured by a visual analogue scale (VAS) of the mean pain (VAS mean scores) on the basis of information from patient diaries. Secondary end points included pain and quality of life (determined from patient questionnaires), pharmacokinetics, and safety. RESULTS: At days 50-52, VAS mean scores did not differ significantly between the THC and placebo groups (F1,46 = 0.016; P = .901). Between the start and end of the study, VAS mean scores decreased by 1.6 points (40%) in the THC group compared with 1.9 points (37%) in the placebo group. No differences were observed in secondary outcomes. Oral THC was generally well-absorbed. Seven patients in the THC group stopped taking the tablets because of adverse events, compared with 2 patients in the placebo group. All (possibly) related adverse events were mild or moderate. CONCLUSIONS: In a phase 2 study, we found no difference between a THC tablet and a placebo tablet in reducing pain measures in patients with chronic abdominal pain. THC, administered 3 times daily, was safe and well-tolerated during a 50-day to 52-day treatment period. ClinicalTrials.gov number: NCT01562483 and NCT01551511.

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Cannabinoids in attention-deficit/hyperactivity disorder: A randomised-controlled trial.

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Journal European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology
Year 2017
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This article is included in 3 Systematic reviews Systematic reviews (3 references)

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Adults with ADHD describe self-medicating with cannabis, with some reporting a preference for cannabis over ADHD medications. A small number of psychiatrists in the US prescribe cannabis medication for ADHD, despite there being no evidence from randomised controlled studies. The EMA-C trial (Experimental Medicine in ADHD-Cannabinoids) was a pilot randomised placebo-controlled experimental study of a cannabinoid medication, Sativex Oromucosal Spray, in 30 adults with ADHD. The primary outcome was cognitive performance and activity level using the QbTest. Secondary outcomes included ADHD and emotional lability (EL) symptoms. From 17.07.14 to 18.06.15, 30 participants were randomly assigned to the active (<i>n</i> = 15) or placebo (<i>n</i> = 15) group. For the primary outcome, no significant difference was found in the ITT analysis although the overall pattern of scores was such that the active group usually had scores that were better than the placebo group (Est = −0.17, 95%CI-0.40 to 0.07, <i>p</i> = 0.16, <i>n</i> = 15/11 active/placebo). For secondary outcomes Sativex was associated with a nominally significant improvement in hyperactivity/impulsivity (<i>p</i> = 0.03) and a cognitive measure of inhibition (<i>p</i> = 0.05), and a trend towards improvement for inattention (<i>p</i> = 0.10) and EL (<i>p</i> = 0.11). Per-protocol effects were higher. Results did not meet significance following adjustment for multiple testing. One serious (muscular seizures/spasms) and three mild adverse events occurred in the active group and one serious (cardiovascular problems) adverse event in the placebo group. Adults with ADHD may represent a subgroup of individuals who experience a reduction of symptoms and no cognitive impairments following cannabinoid use. While not definitive, this study provides preliminary evidence supporting the self-medication theory of cannabis use in ADHD and the need for further studies of the endocannabinoid system in ADHD. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

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Medical cannabis for the treatment of Tourette syndrome: a descriptive analysis of 24 patients.

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Journal Movement disorders
Year 2017

This article is included in 1 Systematic review Systematic reviews (1 reference)

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Patterns of marijuana use among psychiatry patients with depression and its impact on recovery.

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Journal Journal of affective disorders
Year 2017
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Depression is associated with substance-related problems that worsen depression-related disability. Marijuana is frequently used by those with depression, yet whether its use contributes to significant barriers to recovery in this population has been understudied. METHOD: Participants were 307 psychiatry outpatients with depression; assessed at baseline, 3-, and 6-months on symptom (PHQ-9 and GAD-7), functioning (SF-12) and past-month marijuana use for a substance use intervention trial. Longitudinal growth models examined patterns and predictors of marijuana use and its impact on symptom and functional outcomes. RESULTS: A considerable number of (40.7%; n=125) patients used marijuana within 30-days of baseline. Over 6-months, marijuana use decreased (B=-1.20, p<.001), but patterns varied by demographic and clinical characteristics. Depression (B=0.03, p<.001) symptoms contributed to increased marijuana use over the follow-up, and those aged 50+(B=0.44, p<.001) increased their marijuana use compared to the youngest age group. Marijuana use worsened depression (B=1.24, p<.001) and anxiety (B=0.80, p=.025) symptoms; marijuana use led to poorer mental health (B=-2.03, p=.010) functioning. Medical marijuana (26.8%; n=33) was associated with poorer physical health (B=-3.35, p=.044) functioning. LIMITATIONS: Participants were psychiatry outpatients, limiting generalizability. CONCLUSIONS: Marijuana use is common and associated with poor recovery among psychiatry outpatients with depression. Assessing for marijuana use and considering its use in light of its impact on depression recovery may help improve outcomes.

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Open label study of cannabidiol in Parkinson's disease.

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Authors Leehey M , Liu Y , Epstein C , et al.
Journal Movement disorders
Year 2017

This article is included in 1 Systematic review Systematic reviews (1 reference)

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Medical cannabis use among patients with chronic pain in an interdisciplinary pain rehabilitation program: Characterization and treatment outcomes.

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Authors Shah A , Craner J , Cunningham JL
Journal Journal of substance abuse treatment
Year 2017
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This article is included in 1 Broad synthesis Broad syntheses (1 reference) 3 Systematic reviews Systematic reviews (3 references)

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INTRODUCTION: Cannabis is increasingly being used in the treatment of chronic pain. However, there is a lack of available research in the population of patients with chronic pain who are using cannabis. The current study examines clinical and treatment characteristics for patients who are admitted to a 3-week outpatient interdisciplinary chronic pain rehabilitation program. METHOD: Participants (N=48) included patients with a positive urine drug screen for 9-carboxy-tetrahydrocannabinol (THC(+); n=24) and a matched comparison sample of patients with a negative screen (THC(-); n=24). Participants were matched for age, gender, race, education, and current prescription opioid use. Measures of pain, functioning, and quality of life were completed at admission and discharge. Medical chart review was conducted to assess medication and substance use history. RESULTS: Participants with a positive screen for THC were more likely to report a past history of illicit substance use, alcohol abuse, and current tobacco use. Cannabis use was not associated with a significantly lower morphine equivalence level for participants using prescription opioids (n=14). Both groups of participants reported significant improvement in pain severity, pain interference, depressive symptoms, and pain catastrophizing. There were no group- or treatment-related differences in these outcome variables. DISCUSSION: Results provide preliminary evidence that patients with chronic pain using cannabis may benefit from an interdisciplinary chronic pain program. Patients with chronic pain using cannabis may be at higher risk for substance-related negative outcomes, although more research is needed to understand this relationship.