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1.
BMC Psychiatry ; 24(1): 175, 2024 Mar 04.
Article in English | MEDLINE | ID: mdl-38433233

ABSTRACT

BACKGROUND: Cannabis use disorder (CUD) is increasingly common and contributes to a range of health and social problems. Cannabidiol (CBD) is a non-intoxicating cannabinoid recognised for its anticonvulsant, anxiolytic and antipsychotic effects with no habit-forming qualities. Results from a Phase IIa randomised clinical trial suggest that treatment with CBD for four weeks reduced non-prescribed cannabis use in people with CUD. This study examines the efficacy, safety and quality of life of longer-term CBD treatment for patients with moderate-to-severe CUD. METHODS/DESIGN: A phase III multi-site, randomised, double-blinded, placebo controlled parallel design of a 12-week course of CBD to placebo, with follow-up at 24 weeks after enrolment. Two hundred and fifty adults with moderate-to-severe CUD (target 20% Aboriginal), with no significant medical, psychiatric or other substance use disorders from seven drug and alcohol clinics across NSW and VIC, Australia will be enrolled. Participants will be administered a daily dose of either 4 mL (100 mg/mL) of CBD or a placebo dispensed every 3-weeks. All participants will receive four-sessions of Cognitive Behavioural Therapy (CBT) based counselling. Primary endpoints are self-reported cannabis use days and analysis of cannabis metabolites in urine. Secondary endpoints include severity of CUD, withdrawal severity, cravings, quantity of use, motivation to stop and abstinence, medication safety, quality of life, physical/mental health, cognitive functioning, and patient treatment satisfaction. Qualitative research interviews will be conducted with Aboriginal participants to explore their perspectives on treatment. DISCUSSION: Current psychosocial and behavioural treatments for CUD indicate that over 80% of patients relapse within 1-6 months of treatment. Pharmacological treatments are highly effective with other substance use disorders but there are no approved pharmacological treatments for CUD. CBD is a promising candidate for CUD treatment due to its potential efficacy for this indication and excellent safety profile. The anxiolytic, antipsychotic and neuroprotective effects of CBD may have added benefits by reducing many of the mental health and cognitive impairments reported in people with regular cannabis use. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry: ACTRN12623000526673 (Registered 19 May 2023).


Subject(s)
Anti-Anxiety Agents , Antipsychotic Agents , Cannabidiol , Cannabis , Hallucinogens , Marijuana Abuse , Substance-Related Disorders , Adult , Humans , Cannabidiol/therapeutic use , Quality of Life , Australia , Randomized Controlled Trials as Topic , Clinical Trials, Phase III as Topic
2.
BMC Psychiatry ; 18(1): 140, 2018 05 18.
Article in English | MEDLINE | ID: mdl-29776349

ABSTRACT

BACKGROUND: The cannabis extract nabiximols (Sativex®) effectively supresses withdrawal symptoms and cravings in treatment resistant cannabis dependent individuals, who have high relapse rates following conventional withdrawal treatments. This study examines the efficacy, safety and cost-effectiveness of longer-term nabiximols treatment for outpatient cannabis dependent patients who have not responded to previous conventional treatment approaches. METHODS/DESIGN: A phase III multi-site outpatient, randomised, double-blinded, placebo controlled parallel design, comparing a 12-week course of nabiximols to placebo, with follow up at 24 weeks after enrolment. Four specialist drug and alcohol outpatient clinics in New South Wales, Australia. One hundred forty-two treatment seeking cannabis dependent adults, with no significant medical, psychiatric or other substance use disorders. Nabiximols is an oromucosal spray prescribed on a flexible dose regimen to a maximum daily dose of 32 sprays; 8 sprays (total 21.6 mg tetrahydrocannabinol (THC) and 20 mg cannabidiol (CBD)) four times a day, or matching placebo, dispensed weekly. All participants will receive six-sessions of individual cognitive behavioural therapy (CBT) and weekly clinical reviews. Primary endpoints are use of non-prescribed cannabis (self-reported cannabis use days, urine toxicology), safety measures (adverse events and abuse liability), and cost effectiveness (incremental cost effectiveness in achieving additional Quality Adjusted Life Years). Secondary outcomes include, improvement in physical and mental health parameters, substance use other than cannabis, cognitive functioning and patient satisfaction measures. DISCUSSION: This is the first outpatient community-based randomised controlled study of nabiximols as an agonist replacement medication for treating cannabis dependence, targeting individuals who have not previously responded to conventional treatment approaches. The study and treatment design is modelled upon an earlier study with this population and more generally on other agonist replacement treatments (e.g. nicotine, opioids). TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry: ACTRN12616000103460 (Registered 1st February 2016).


Subject(s)
Cannabidiol/therapeutic use , Cannabinoids/adverse effects , Dronabinol/therapeutic use , Marijuana Abuse/drug therapy , Substance Withdrawal Syndrome/drug therapy , Adult , Australia , Cognition/drug effects , Cognitive Behavioral Therapy/methods , Combined Modality Therapy , Craving/drug effects , Double-Blind Method , Drug Combinations , Female , Humans , Male , New South Wales , Randomized Controlled Trials as Topic , Treatment Outcome
3.
AIDS Res Ther ; 15(1): 6, 2018 03 08.
Article in English | MEDLINE | ID: mdl-29519243

ABSTRACT

OBJECTIVE: To assess the prevalence of non-AIDS co-morbidities (NACs) and predictors of adverse health outcomes amongst people living with HIV in order to identify health needs and potential gaps in patient management. DESIGN: Retrospective, non-consecutive medical record audit of patients attending a publicly funded HIV clinic in metropolitan Sydney analysed for predictors of adverse health outcomes. We developed a scoring system based on the validated Charlson score method for NACs, mental health and social issues and confounders were selected using directed acyclic graph theory under the principles of causal inference. RESULTS: 211 patient files were audited non-consecutively over 6 weeks. 89.5% were male; 41.8% culturally and linguistically diverse and 4.1% were of Aboriginal/Torres Strait Islander origin. Half of patients had no general practitioner and 25% were ineligible for Medicare subsidised care. The most common NACs were: cardiovascular disease (25%), hepatic disease (21%), and endocrinopathies (20%). One-third of patients had clinical anxiety, one-third major depression and almost half of patients had a lifetime history of tobacco smoking. Five predictors of poor health outcomes were identified: (1) co-morbidity score was associated with hospitalisation (odds ratio, OR 1.58; 95% CI 1.01-2.46; p = 0.044); (2) mental health score was associated with hospitalisation (OR 1.79; 95% CI 1.22-2.62; p = 0.003) and poor adherence to ART (OR 2.34; 95% CI 1.52-3.59; p = 0.001); (3) social issues score was associated with genotypic resistance (OR 2.61; 95% CI 1.48-4.59; p = 0.001), co-morbidity score (OR 1.69; 95% CI 1.24-2.3; p = 0.001) and hospitalisation (OR 1.72; 95% CI 1.1-2.7; p = 0.018); (4) body mass index < 20 was associated with genotypic resistance (OR 6.25; 95% CI 1.49-26.24; p = 0.012); and (5) Medicare eligibility was associated with co-morbidity score (OR 2.21; 95% CI 1.24-3.95; p = 0.007). CONCLUSION: Most HIV patients are healthy due to effective antiretroviral therapy; however, NACs and social/mental health issues are adding to patient complexity. The current findings underpin the need for multidisciplinary management beyond routine viral load and CD4 count monitoring.


Subject(s)
HIV Infections/epidemiology , Acquired Immunodeficiency Syndrome/epidemiology , Antiretroviral Therapy, Highly Active , CD4 Lymphocyte Count , Comorbidity , HIV/genetics , HIV Infections/drug therapy , HIV Infections/immunology , HIV Infections/virology , Humans , Mental Health , Outcome Assessment, Health Care , Prognosis , Risk Factors , Viral Load
4.
J Appl Res Intellect Disabil ; 31(2): e253-e264, 2018 Mar.
Article in English | MEDLINE | ID: mdl-28503841

ABSTRACT

BACKGROUND: Little research exists comparing the social networks of people with intellectual disability (ID) from South Asian and White backgrounds. This UK study reports on the barriers that South Asian people with intellectual disability face in relation to social inclusion compared to their White counterparts. MATERIALS AND METHODS: A mixed-methods research design was adopted to explore the social lives of 27 men (15 White; 12 South Asian) and 20 women (10 White; 10 South Asian with intellectual disability). Descriptive and parametric tests were used to analyse the quantitative data. RESULTS: The average network size of the whole group was 32 members. South Asian participants had more family members whilst White participants had more service users and staff in their networks; 96% network members from White intellectual disability group were also of White background, whilst the South Asian group had mixed ethnic network members. CONCLUSIONS: Social networks of individuals with intellectual disability in this study were found to be larger overall in comparison with previous studies, whilst network structure differed between the White and South Asian population. These differences have implications relating to future service planning and appropriateness of available facilities.


Subject(s)
Asian People , Intellectual Disability/ethnology , Social Identification , Social Support , White People , Adult , Female , Humans , Male , Middle Aged , United Kingdom , Young Adult
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