Cannabidiol for the treatment of cannabis use disorder: a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial

The Lancet Psychiatry - Tập 7 - Trang 865-874 - 2020
Tom P Freeman1,2,3,4, Chandni Hindocha2,3,5, Gianluca Baio6, Natacha D C Shaban2, Emily M Thomas2, Danica Astbury2, Abigail M Freeman2, Rachel Lees1, Sam Craft1,4, Paul D Morrison7, Michael A P Bloomfield2,3,5,8,9, Dominic O'Ryan10, Jane Kinghorn11, Celia J A Morgan12, Ali Mofeez9, H Valerie Curran2,5
1Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath, UK
2Clinical Psychopharmacology Unit, University College London, London, UK
3Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, University College London, London, UK
4National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
5National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK
6Department of Statistical Science, University College London, London, UK
7Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
8The Traumatic Stress Clinic, St Pancras Hospital, Camden and Islington National Health Service Foundation Trust, London, UK
9Pain Management Centre, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK
10Substance Misuse Services, Camden and Islington National Health Service Foundation Trust, London, UK
11Translational Research Office, School of Life and Medical Sciences, University College London, London, UK
12Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK

Tài liệu tham khảo

Curran, 2016, Keep off the grass? Cannabis, cognition and addiction, Nat Rev Neurosci, 17, 293, 10.1038/nrn.2016.28 Degenhardt, 2018, The global burden of disease attributable to alcohol and drug use in 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016, Lancet Psychiatry, 5, 987, 10.1016/S2215-0366(18)30337-7 Freeman, 2019, Increasing potency and price of cannabis in Europe, 2006–16, Addiction, 114, 1015, 10.1111/add.14525 Chandra, 2019, New trends in cannabis potency in USA and Europe during the last decade (2008–2017), Eur Arch Psychiatry Clin Neurosci, 269, 5, 10.1007/s00406-019-00983-5 Freeman, 2015, Examining the profile of high-potency cannabis and its association with severity of cannabis dependence, Psychol Med, 45, 3181, 10.1017/S0033291715001178 Meier, 2017, Associations between butane hash oil use and cannabis-related problems, Drug Alcohol Depend, 179, 25, 10.1016/j.drugalcdep.2017.06.015 Freeman, 2018, Changes in cannabis potency and first-time admissions to drug treatment: a 16-year study in the Netherlands, Psychol Med, 48, 2346, 10.1017/S0033291717003877 2019 2018 Di Forti, 2019, The contribution of cannabis use to variation in the incidence of psychotic disorder across Europe (EU-GEI): a multicentre case-control study, Lancet Psychiatry, 6, 427, 10.1016/S2215-0366(19)30048-3 Nielsen, 2019, Pharmacotherapies for cannabis dependence, Cochrane Database Syst Rev, 12 Bisogno, 2001, Molecular targets for cannabidiol and its synthetic analogues: effect on vanilloid VR1 receptors and on the cellular uptake and enzymatic hydrolysis of anandamide, Br J Pharmacol, 134, 845, 10.1038/sj.bjp.0704327 Laprairie, 2015, Cannabidiol is a negative allosteric modulator of the cannabinoid CB1 receptor, Br J Pharmacol, 172, 4790, 10.1111/bph.13250 Freeman, 2019, Medicinal use of cannabis based products and cannabinoids, BMJ, 365 Freeman, 2019, How does cannabidiol (CBD) influence the acute effects of delta-9-tetrahydrocannabinol (THC) in humans? A systematic review, Neurosci Biobehav Rev, 107, 696, 10.1016/j.neubiorev.2019.09.036 Morgan, 2010, Cannabidiol attenuates the appetitive effects of Δ 9-tetrahydrocannabinol in humans smoking their chosen cannabis, Neuropsychopharmacology, 35, 1879, 10.1038/npp.2010.58 Hindocha, 2018, Cannabidiol reverses attentional bias to cigarette cues in a human experimental model of tobacco withdrawal, Addiction, 113, 1696, 10.1111/add.14243 Hurd, 2019, Cannabidiol for the reduction of cue-induced craving and anxiety in drug-abstinent individuals with heroin use disorder: a double-blind randomized placebo-controlled trial, Am J Psychiatry, 176, 911, 10.1176/appi.ajp.2019.18101191 Ren, 2009, Cannabidiol, a nonpsychotropic component of cannabis, inhibits cue-induced heroin seeking and normalizes discrete mesolimbic neuronal disturbances, J Neurosci, 29, 14764, 10.1523/JNEUROSCI.4291-09.2009 Morgan, 2013, Cannabidiol reduces cigarette consumption in tobacco smokers: preliminary findings, Addict Behav, 38, 2433, 10.1016/j.addbeh.2013.03.011 Chesney, 2020, Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials, Neuropsychopharmacology, 10.1038/s41386-020-0667-2 Crippa, 2013, Cannabidiol for the treatment of cannabis withdrawal syndrome: a case report, J Clin Pharm Ther, 38, 162, 10.1111/jcpt.12018 Shannon, 2015, Cannabidiol oil for decreasing addictive use of marijuana: a case report, Integr Med (Encinitas), 14, 31 Solowij, 2018, Therapeutic effects of prolonged cannabidiol treatment on psychological symptoms and cognitive function in regular cannabis users: a pragmatic open-label clinical trial, Cannabis Cannabinoid Res, 3, 21, 10.1089/can.2017.0043 Allsop, 2015, Cannabinoid replacement therapy (CRT): nabiximols (sativex) as a novel treatment for cannabis withdrawal, Clin Pharmacol Ther, 97, 571, 10.1002/cpt.109 Lintzeris, 2019, Nabiximols for the treatment of cannabis dependence: a randomized clinical trial, JAMA Intern Med, 179, 1242, 10.1001/jamainternmed.2019.1993 Trigo, 2018, Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: a pilot randomized clinical trial, PLoS One, 13, 10.1371/journal.pone.0190768 Zuardi, 2017, Inverted U-shaped dose-response curve of the anxiolytic effect of cannabidiol during public speaking in real life, Front Pharmacol, 8, 259, 10.3389/fphar.2017.00259 Campos, 2008, Involvement of 5HT1A receptors in the anxiolytic-like effects of cannabidiol injected into the dorsolateral periaqueductal gray of rats, Psychopharmacology (Berl), 199, 223, 10.1007/s00213-008-1168-x Leweke, 2012, Cannabidiol enhances anandamide signaling and alleviates psychotic symptoms of schizophrenia, Transl Psychiatry, 2, e94, 10.1038/tp.2012.15 Cunha, 1980, Chronic administration of cannabidiol to healthy volunteers and epileptic patients, Pharmacology, 21, 175, 10.1159/000137430 Kotz, 2013, Predictive validity of the Motivation To Stop Scale (MTSS): a single-item measure of motivation to stop smoking, Drug Alcohol Depend, 128, 15, 10.1016/j.drugalcdep.2012.07.012 Hindocha, 2016, No smoke without tobacco: a global overview of cannabis and tobacco routes of administration and their association with intention to quit, Front Psychiatry, 7, 104, 10.3389/fpsyt.2016.00104 Taylor, 2018, A phase I, randomized, double-blind, placebo-controlled, single ascending dose, multiple dose, and food effect trial of the safety, tolerability and pharmacokinetics of highly purified cannabidiol in healthy subjects, CNS Drugs, 32, 1053, 10.1007/s40263-018-0578-5 Miller, 2012 Gates, 2016, Psychosocial interventions for cannabis use disorder, Cochrane Database Syst Rev, 2016 Curran, 2018, Which biological and self-report measures of cannabis use predict cannabis dependency and acute psychotic-like effects?, Psychol Med, 49, 1574, 10.1017/S003329171800226X Sobell, 1992, Timeline follow-back, 41 Allsop, 2011, The Cannabis Withdrawal Scale development: patterns and predictors of cannabis withdrawal and distress, Drug Alcohol Depend, 119, 123, 10.1016/j.drugalcdep.2011.06.003 Buysse, 1989, The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research, Psychiatry Res, 28, 193, 10.1016/0165-1781(89)90047-4 Beck, 1961, An inventory for measuring depression, Arch Gen Psychiatry, 4, 561, 10.1001/archpsyc.1961.01710120031004 Beck, 1988, An inventory for measuring clinical anxiety: psychometric properties, J Consult Clin Psychol, 56, 893, 10.1037/0022-006X.56.6.893 Berry, 2010