scholarly journals First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder

2021 ◽  
pp. 026988112199179
Author(s):  
Ben Sessa ◽  
Laurie Higbed ◽  
Steve O’Brien ◽  
Claire Durant ◽  
Chloe Sakal ◽  
...  

Background: 3,4-methylenedioxymethamphetamine (MDMA) therapy has qualities that make it potentially well suited for patients with addictions, but this has never been explored in a research study. We present data from the Bristol Imperial MDMA in Alcoholism (BIMA) study. This is the first MDMA addiction study, an open-label safety and tolerability proof-of-concept study investigating the potential role for MDMA therapy in treating patients with alcohol use disorder (AUD). Aims: This study aimed to assess if MDMA-assisted psychotherapy can be delivered safely and can be tolerated by patients with AUD post detoxification. Outcomes regarding drinking behaviour, quality of life and psychosocial functioning were evaluated. Methods: Fourteen patients with AUD completed a community alcohol detoxification and received an eight-week course of recovery-based therapy. Participants received two sessions with MDMA (187.5 mg each session). Psychological support was provided before, during and after each session. Safety and tolerability were assessed alongside psychological and physiological outcome measures. Alcohol use behaviour, mental well-being and functioning data were collected for nine months after alcohol detoxification. Results: MDMA treatment was well tolerated by all participants. No unexpected adverse events were observed. Psychosocial functioning improved across the cohort. Regarding alcohol use, at nine months post detox, the average units of alcohol consumption by participants was 18.7 units per week compared to 130.6 units per week before the detox. This compares favourably to a previous observational study (the ‘Outcomes’ study) by the same team with a similar population of people with AUD. Conclusions: This study provides preliminary support for the safety and tolerability of a novel intervention for AUD post detox. Further trials to examine better the therapeutic potential of this approach are now indicated.

Author(s):  
Katie Witkiewitz ◽  
Henry R. Kranzler ◽  
Kevin A. Hallgren ◽  
Deborah S. Hasin ◽  
Arnie P. Aldridge ◽  
...  

Abstract Background The World Health Organization (WHO) categorizes alcohol consumption according to grams consumed into low-, medium-, high-, and very-high-risk drinking levels (RDLs). Although abstinence has been considered the ideal outcome of alcohol treatment, reductions in WHO RDLs have been proposed as primary outcomes for alcohol use disorder (AUD) trials. Objective The current study examines the stability of WHO RDL reductions and the association between RDL reductions and long-term functioning for up to 3 years following treatment. Design and Participants Secondary data analysis of patients with AUD enrolled in the COMBINE Study and Project MATCH, two multi-site, randomized AUD clinical trials, who were followed for up to 3 years post-treatment (COMBINE: n = 694; MATCH: n = 806). Measures Alcohol use was measured via calendar-based methods. We estimated all models in the total sample and among participants who did not achieve abstinence during treatment. Key Results One-level RDL reductions were achieved by 84% of patients at the end of treatment, with 84.9% of those individuals maintaining that reduction at a 3-year follow-up. Two-level RDL reductions were achieved by 68% of patients at the end of treatment, with 77.7% of those individuals maintaining that reduction at a 3-year follow-up. One- and two-level RDL reductions at the end of treatment were associated with significantly better mental health, quality of life (including physical quality of life), and fewer drinking consequences 3 years after treatment (p < 0.05), as compared to no change or increased drinking. Conclusion AUD patients can maintain WHO RDL reductions for up to 3 years after treatment. Patients who had WHO RDL reductions functioned significantly better than those who did not reduce their drinking. These findings are consistent with prior reports suggesting that drinking reductions, short of abstinence, yield meaningful improvements in patient health, well-being, and functioning.


2019 ◽  
Vol 12 (7) ◽  
pp. e230109 ◽  
Author(s):  
Ben Sessa ◽  
Chloe Sakal ◽  
Steve O’Brien ◽  
David Nutt

We present the preliminary data in an ongoing open-label safety and tolerability proof of concept study exploring the potential role for 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in treating patients with alcohol use disorder. At this stage, seven participants have completed the full 8-week MDMA-assisted psychotherapy course, including two therapy sessions each with MDMA. This paper focuses on the safety and tolerability of the therapeutic course for the first four participants to complete treatment. Longer-term outcomes of drinking behaviour will be presented later when the full project data are published. Results show all four participants have successfully tolerated the treatment. There have been no serious adverse events related to MDMA, no unexpected physiological responses to the MDMA sessions or changes to blood results or electrocardiograms, measured before and after the 8-week course. We conclude that the treatment is well- tolerated and are making plans to expand the project into a randomised placebo-controlled study.


BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S266-S266
Author(s):  
Chau Sian Lim ◽  
Zhen Wei Lew ◽  
Yoke Chiang Ng ◽  
Lai Huat Peh ◽  
Hatta Santoso Ong

AimsThis study aims to find out how alcohol use disorder (AUD) correlates to personal well-being and life satisfaction.BackgroundAUD is prevalent and leads to significant physical, physiological, and social-occupational impairment. Mental well-being involves the overall positive psychological state of a person – being well adjusted, socially engaged, and emotionally healthy. Despite the paradigm shift from purely treating mental illness to promoting positive mental health, there is limited literature describing the relationship between alcohol use disorder and mental well-being.MethodThis cross-sectional study was conducted in a general hospital in Singapore. Patients admitted across a span of two years were screened for possible alcohol use disorder. Patients were included if they were male, aged 21 years and above, and had the mental capacity to give consent. They were excluded if they had illicit drug use, acute mental illness, inability or refusal to give consent, or if they were already receiving intervention for addiction issues. Participants were administered the Alcohol Use Disorders Identification Test (AUDIT). Those who scored 8 or above were classified as being at risk for AUD, while those who scored 7 or less were classified as at low risk. They were also administered the Personal Wellbeing Index (PWI) and the “Satisfaction with Life as a Whole” question. The PWI measures individuals’ subjective well-being across seven domains. The “Satisfaction with Life as a Whole” question measures, on an eleven-point Likert scale, how satisfied the respondent feels with life in general. Demographic data were also collected and STATA v. 12.1 was used for statistical analysis.ResultAmong a total of 134 participants, 25 of them scored ≥8 on the AUDIT and 109 scored 7 or less. On the PWI, the group at risk scored significantly lower at 71.3 (95% CI: 66.0–76.7) compared to the group not at risk at 77.9 (95% CI: 75.8–79.9), p < 0.01. The results were similar on the “Satisfaction with Life as a Whole” item. The group at risk had a mean of 6.72 (95% CI: 6.03–7.41) while the group not at risk had a mean of 7.67 (95% CI: 7.41–7.93), both p < 0.01. The differences between the high risk and low risk groups remained statistically significant even after adjusting for differences in age, race, education level, and employment status.ConclusionThis study demonstrated a statistically significant association between AUD and personal well-being as well as satisfaction with life among males.


GeroPsych ◽  
2019 ◽  
Vol 32 (3) ◽  
pp. 125-134
Author(s):  
Mechthild Niemann-Mirmehdi ◽  
Andreas Häusler ◽  
Paul Gellert ◽  
Johanna Nordheim

Abstract. To date, few studies have focused on perceived overprotection from the perspective of people with dementia (PwD). In the present examination, the association of perceived overprotection in PwD is examined as an autonomy-restricting factor and thus negative for their mental well-being. Cross-sectional data from the prospective DYADEM study of 82 patient/partner dyads (mean age = 74.26) were used to investigate the association between overprotection, perceived stress, depression, and quality of life (QoL). The analyses show that an overprotective contact style with PwD has a significant positive association with stress and depression, and has a negative association with QoL. The results emphasize the importance of avoiding an overprotective care style and supporting patient autonomy.


Healthcare ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 141
Author(s):  
Hwee Wee ◽  
Gweon-Young Kang

Addiction is related to aggression and quality of life. This study examined the relationship between these three factors according to occupation group in a mixed urban/rural area to better understand adult addiction problems. This study was a secondary data analysis of cross-sectional data collected by a 2017 regional survey of adults living in Gunsan City, South Korea. The survey included 500 people split into the unemployed (Group1), full-time homemakers (Group2), and primary (Group3), secondary (Group4), and tertiary (Group5) industry workers. Addiction problems and aggression were positively correlated (p < 0.01). Aggression and alcohol use disorder were correlated in Group3 (r = 0.31), Group4 (r = 0.34), and Group5 (r = 0.32), and aggression and smartphone addiction were correlated in Group2 (r = 0.39) and Group4 (r = 0.31). Problem gambling was correlated with aggression in Group5 (r = 0.39). A negative relationship between quality of life and alcohol use disorder occurred in Group1 (r = −0.36). According to the occupation group, the relationships between addiction problems, aggression, and quality of life were different. These findings suggest that addiction management for adults should be implemented in consideration of occupation groups.


Autism ◽  
2021 ◽  
Vol 25 (5) ◽  
pp. 1469-1480
Author(s):  
Maya Bowri ◽  
Laura Hull ◽  
Carrie Allison ◽  
Paula Smith ◽  
Simon Baron-Cohen ◽  
...  

This study explored demographic and psychological predictors of alcohol use and misuse in a high-functioning, community sample of 237 autistic adults aged 18–75 (mean = 41.92 and standard deviation = 13.3) recruited in the United Kingdom. An online survey measured demographic information, autistic traits, depression, generalised anxiety, social anxiety, mental well-being, social camouflaging and alcohol use with the Alcohol Use Disorders Identification Test. The sample was divided into three groups (non-drinkers, non-hazardous drinkers and hazardous drinkers) and multinomial logistic regression models were used to investigate associations between alcohol use and demographic factors, autistic traits, mental health variables and social camouflaging. Our results demonstrated a U-shaped pattern among autistic adults, with non-drinkers and hazardous drinkers scoring significantly higher than non-hazardous drinkers on levels of autistic traits, depression, generalised anxiety and social anxiety. In multivariate analysis, autistic non-drinkers were less likely to be male (odds ratio = 0.44; 95% confidence interval = 0.22–0.87) and had more autistic traits (odds ratio = 2.50; 95% confidence interval = 1.19–5.28). Gender and level of autistic traits may be the most significant factors in predicting alcohol use in the autistic community. Lay abstract Alcohol use and misuse are associated with a variety of negative physical, psychological and social consequences. The limited existing research on substance use including alcohol use in autistic adults has yielded mixed findings, with some studies concluding that autism reduces the likelihood of substance use and others suggesting that autism may increase an individual’s risk for substance misuse. This study investigated demographic and psychological predictors of alcohol use and misuse in a sample of 237 autistic adults. An online survey was used to obtain data on demographic information, autistic traits, depression, generalised anxiety, social anxiety, mental well-being, social camouflaging and alcohol use. The sample was divided into three groups (non-drinkers, non-hazardous drinkers and hazardous drinkers) in order to investigate associations between alcohol use and demographic factors, autistic traits, mental health variables and social camouflaging. Our results demonstrated a U-shaped pattern among autistic adults, with non-drinkers and hazardous drinkers scoring higher than non-hazardous drinkers on levels of autistic traits, depression, generalised anxiety and social anxiety. Autistic non-drinkers were less likely to be male and had more autistic traits. Gender and level of autistic traits may be the most significant factors in predicting alcohol use in the autistic community.


2020 ◽  
Vol 8 (1) ◽  
pp. 147
Author(s):  
Veeraraja B. Sathenahalli ◽  
G. R. Rajashekar Murthy ◽  
Netra Gouda ◽  
Sanjay K. Shivanna

Background: Thalassemia is an autosomal recessive congenital disease caused by the reduced or absent beta globin chain synthesis of hemoglobin tetramer. The degree of imbalance between alpha and non alpha globin chains determines the severity of clinical manifestations. The disabling nature of the disease and chronic therapy affects the normal life causing psychosocial burden. Overall patient’s life, such as education, free-time, physical activities, skills, capabilities, and family adjustment is affected. The effects of which often result in psychological, emotional and social compromise. Health-Related Quality of Life (HRQoL) measurement is a multidimensional concept that focuses on the impact of the disease and its treatment on the well being of an individual.Methods: A descriptive observational hospital based study was conducted over a period of 3 months. Transfusion dependency in thalassemic children aged between 5 years and 18 years was the inclusion criteria. Thalassemic children having debilitating illnesses unrelated to thalassemia were excluded. Quality of life was assessed using Pediatric Quality of Life Inventory (PedsQL™ 4.0)4. The tool assesses the quality of life in five domains: physical functioning (PF: 8 items), psychosocial functioning (sum of emotional, social and school functioning), emotional functioning (EF: 5 items), social functioning (SF: 5 items) and school functioning (SC: 5 items).Results: Total of 125 children were enrolled with a mean age of 9.4±4.6 years (age range 5-18 yrs). According to the PedsQL questionnaire, the quality of life was similarly assessed by both parents and children. The total mean QoL score of the parents was 72.36±11.47 and of the children was 77.63±14.17. Emotional, school and psycho-social function were significantly affected according to both child and parents without statistical significance.Conclusions: Thalassaemia patients and their parents require lifelong psychological support for prevention of mental health issues. By increasing the awareness and knowledge levels of the parents, we can help sick children in developing countries to get the best care locally and to thus improve HRQoL.


2020 ◽  
Vol 12 (4) ◽  
pp. 69
Author(s):  
EunJu Song

Many patients with alcohol use disorder experienced insomnia or sleep disturbances. However, their sleep problems rarely addressed in the treatment process. It may prove beneficial if treatment programs should intend to help prevent the recurrence of alcohol use disorder by solving patients&rsquo; sleep-induced problems and accordingly include appropriate sleep interventions. The present study employed a descriptive design and conducted a cross-sectional survey to assess the relationship among sleep quality, score on the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES), abstinence self-efficacy, and quality of life in inpatients with alcohol use disorders. Data were collected from June to August 2018, from 117 patients admitted to the psychiatric ward for alcohol-use patients in two mental hospitals in South Korea. Sleep quality was significantly correlated with the SOCRATES score (r = .247, p = .007) and quality of life (r = -.346, p = .001). However, it showed no relationship with abstinence self-efficacy (r = -.066, p = .477). These findings suggest that abstinence programs need to employ a comprehensive approach instead of primarily focusing on maintaining abstinence and cessation of alcohol use. However, both sleep disturbances and alcohol abstinence require patience and prolonged treatment. Thus, it is a challenge to design concrete interventions to address the sleep problems experienced by patients with alcohol use disorder.


2021 ◽  
Author(s):  
Najlaa Lahbairi ◽  
Alice Laniepce ◽  
Shailendra Segobin ◽  
Nicolas Cabé ◽  
Céline Boudehent ◽  
...  

Abstract Background. Health-related quality of life (HRQoL) is an important clinical outcome in Alcohol Use Disorder (AUD) and is considered as a relevant indicator of treatment success. While a better understanding of the factors affecting HRQoL would enable to adjust patients’ care to favour treatment outcome, the determinants of HRQoL in AUD remain unclear. This study aims at describing HRQoL in AUD patients and at identifying its best predictors. Methods. We included 53 recently detoxified patients with severe AUD (sAUD) and 38 healthy controls (HC). They underwent a cognitive assessment and filled in questionnaires concerning socio-demographics, alcohol history, sleep quality, depression, anxiety and impulsivity. Additionally, a HRQoL questionnaire especially designed for AUD patients (Alcohol Quality of Life Scale; AQoLS) was used.Results. sAUD patients reported that alcohol affects their HRQoL mainly in the “negative emotions”, “control”, “relationships”, and “sleep” domains. Compared to HC, they were impaired on episodic memory, working memory, executive functions, and processing speed tasks. They also reported lower sleep quality, higher depression, anxiety and impulsivity. No association was found between AQoLS total score and socio-demographics, cognitive performance, or sleep quality in patients. We found a significant correlation between HRQoL and depression/anxiety as well as impulsivity. Anxiety and impulsivity were indeed the only significant predictors of HRQoL, explaining 47.7% of the variance. Conclusions. Anxiety and impulsivity are crucial determinants of HRQoL in recently detoxified sAUD patients. Since anxiety and impulsivity are frequent issues in addiction and especially in AUD, they should be particularly considered by clinicians to favour treatment outcomes.


2021 ◽  
Vol LIII (2) ◽  
pp. 46-56
Author(s):  
Aleksey I. Melekhin

Aim. To investigate the effectiveness of the short-term protocol of cognitive behavioral therapy RELEGS M. Hornyak et al. in complex treatment to improve the quality of sleep, reduce the symptoms of depression, anxiety, suicidal thoughts in patients with primary SBN comorbid with chronic insomnia. Methods. Study participants: 68 patients with primary restless legs syndrome with comorbid chronic insomnia. Women 56 (average age 52.110.3 years), men 12 (average age 50.39.4 years). The severity of restless legs syndrome is moderate to severe. The average age of the onset of the disease is 1848 years, the duration of the course of the disease is on average 1415 years. Taking various medications for the management of SBN for an average of 45 years. Study design: a randomized controlled trial, after screening 26 patients were assigned to the main group, underwent combined treatment, took a prolonged form of Pramipexole (Mirapex-PD, 1.5 mg.) and underwent the RELEGS CBT protocol (Restless Legs Skills program, Hornyak, Grossmann, 2018), which integrates the cognitive behavioral insomnia protocol (Morin, 2007) and Mindfulness-Based Stress therapy (Mindfulness-Based Stress Reduction, Bablas, 2016). The control group consisted of 24 people who received only general recommendations on sleep hygiene once. Both groups were treated with dopaminergic agonists under the supervision of a neurologist. Research methods: IRLS, ISI, DBAS-16, sleep diary analysis, actigraphy, BDI, SBQ-R, BAI. Results. The use of the CBT protocol in combination therapy with prolonged-acting dopaminergic agonists in patients with primary restless leg syndrome (mild and moderate severity) with comorbid chronic insomnia, in contrast to simple one-time general recommendations on sleep hygiene, is more effective for reducing dysfunctional behaviors, the spectrum of reinsurance and avoidance behavior both in relation to sleep and symptoms of restless legs. In patients with primary restless legs syndrome who underwent CBT, greater mental well-being was observed, which was expressed in a decrease in the severity of symptoms of insomnia, anxiety, and suicidal behavior after completion and persisted after 3 months of follow-up. Conclusion. As part of a personalized comprehensive approach, along with a drug-based approach and general recommendations for sleep hygiene, the use of short-term CBT (4 sessions, 60 minutes each) can significantly improve mental well-being, improve the quality of sleep of patients with restless legs syndrome with comorbid chronic insomnia.


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