scholarly journals First study of safety and tolerability of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary data on the first four participants

2019 ◽  
Vol 12 (7) ◽  
pp. e230109 ◽  
Author(s):  
Ben Sessa ◽  
Chloe Sakal ◽  
Steve O’Brien ◽  
David Nutt
Keyword(s):  
Alcohol Use ◽  
Preliminary Data ◽  
Alcohol Use Disorder ◽  
Controlled Study ◽  
Drinking Behaviour ◽  
Open Label ◽  
Serious Adverse Events ◽  
Before And After ◽  
Complete Treatment ◽  
Project Data

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.

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 ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Psychosocial Functioning ◽  
Alcohol Use Disorder ◽  
Therapeutic Potential ◽  
Well Being ◽  
Drinking Behaviour ◽  
Open Label ◽  
Alcohol Detoxification ◽  
Mental Well Being

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.

scholarly journals MR-guided focused ultrasound liquid biopsy enriches circulating biomarkers in patients with brain tumors

2021 ◽  
Author(s):  
Ying Meng ◽  
Christopher B Pople ◽  
Suganth Suppiah ◽  
Maheleth Llinas ◽  
Yuexi Huang ◽  
...  
Keyword(s):  
Liquid Biopsy ◽  
Focused Ultrasound ◽  
Brain Regions ◽  
Specific Protein ◽  
Rank Test ◽  
Open Label ◽  
Isocitrate Dehydrogenase 1 ◽  
Serious Adverse Events ◽  
Before And After ◽  
Bbb Opening

Abstract Background Liquid biopsy is promising for early detection, monitoring of response and recurrence of cancer. The blood-brain barrier (BBB) limits the shedding of biomarker, such as cell-free DNA (cfDNA), into the blood, and their detection by conventional assays. Transcranial MR-guided focused ultrasound (MRgFUS) can safely and transiently open the BBB, providing an opportunity for less-invasive access to brain pathology. We hypothesized MRgFUS can enrich the signal of circulating brain-derived biomarkers to aid in liquid biopsy. Methods Nine patients were treated in a prospective single-arm, open-label trial to investigate serial MRgFUS and adjuvant temozolomide combination in patients with glioblastoma (NCT03616860). Blood samples were collected as an exploratory measure within the hours before and after sonication, with control samples from non-brain tumor patients undergoing BBB opening alone (NCT03739905). Results Brain regions averaging 7.8±6.0 cm 3 (range 0.8–23.1 cm 3) were successful treated within 111±39 minutes without any serious adverse events. We found MRgFUS acutely enhanced plasma cfDNA (2.6±1.2 fold, p<0.01, Wilcoxon signed-rank test), neuron-derived extracellular vesicles (3.2±1.9 fold, p<0.01), and brain specific protein S100b (1.4±0.2 fold, p<0.01). Further comparison of the cfDNA methylation profiles suggests a signature that is disease and post-BBB opening specific, in keeping with our hypothesis. We also found cfDNA mutant copies of isocitrate dehydrogenase 1 (IDH1) increased, although this was in only one patient known to harbour the tumor mutation. Conclusions This first-in-human proof-of concept study shows MRgFUS enriches the signal of circulating brain-derived biomarkers, demonstrating the potential of the technology to support liquid biopsy for the brain.

Effects of Comorbid Alcohol Use Disorder on the Clinical Outcomes of Schizophrenia: A Nationwide Population-based Study

2021 ◽  
Author(s):  
Soojin Ahn ◽  
Youngjae Choi ◽  
Woohyeok Choi ◽  
Young Tak Jo ◽  
Harin Kim ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Clinical Outcomes ◽  
Alcohol Use Disorder ◽  
Medication Possession Ratio ◽  
Small Sample ◽  
Control Group ◽  
Diagnostic Code ◽  
Psychiatric Admissions ◽  
Before And After ◽  
The Impact

Abstract BackgroundAlcohol use disorder (AUD) is a common psychiatric comorbidity in schizophrenia, associated with poor clinical outcomes and medication noncompliance. Most previous studies on the effect of alcohol use in patients with schizophrenia had limitations of small sample size and a cross-sectional design. Therefore, this study aimed to use a nationwide population database to investigate the impact of AUD on clinical outcomes of schizophrenia.MethodsData from the Health Insurance Review Agency database in South Korea from January 1, 2007 to December 31, 2016 was used. Among 64,442 patients with incident schizophrenia, 1,598 with comorbid AUD were selected based on the diagnostic code F10. We performed between- and within-group analyses to compare the rates of psychiatric admissions and emergency room (ER) visits and medication possession ratio (MPR) with control patients having schizophrenia matched for the onset age, sex, and observation period.ResultsThe rates of psychiatric admissions and ER visits decreased after the diagnosis of AUD in both groups; however, the decrease was significantly greater in patients with comorbid AUD compared to the control group. While the case group showed an increase in MPR after the diagnosis of AUD, MPR decreased in the control patients. The rates of psychiatric admissions, ER visits and MPR were worse in the schizophrenia group with comorbid AUD both before and after the diagnosis of AUD.ConclusionsClinical outcomes were worse in the comorbid AUD group than in the control group before and after the diagnosis of AUD. Considering that patients with schizophrenia with comorbid AUD had poorer clinical outcomes even before the diagnosis of AUD, schizophrenia with comorbid AUD could be a distinct subtype of schizophrenia.

Executive functioning before and after onset of alcohol use disorder in adolescence. A TRAILS study

2016 ◽  
Vol 78 ◽  
pp. 78-85 ◽  
Author(s):  
Sarai R. Boelema ◽  
Zeena Harakeh ◽  
Martine J.E. van Zandvoort ◽  
Sijmen A. Reijneveld ◽  
Frank C. Verhulst ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Executive Functioning ◽  
Alcohol Use Disorder ◽  
Before And After

scholarly journals Melatonin for Treatment-Seeking Alcohol Use Disorder patients with sleeping problems: A randomized clinical pilot trial

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Marie N. S. Gendy ◽  
Dina Lagzdins ◽  
Jessika Schaman ◽  
Bernard Le Foll
Keyword(s):  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Pilot Trial ◽  
Complex Problem ◽  
Treatment Seeking ◽  
Future Research ◽  
Treatment Change ◽  
Sleeping Problems ◽  
Before And After ◽  
The Difference

Abstract A high percentage of subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties. Lack of sleep could lead AUD patients to relapse or, sometimes, to suicide. Most of the currently prescribed medications to treat this complex problem retain a high risk of side effects and/or dependence. Therefore, the aim of the current clinical trial is to investigate the possibility of the use of a safer treatment, such as the natural health product melatonin, to treat alcohol-related sleeping problems. Sixty treatment-seeking AUD subjects were assigned to melatonin (5 mg) or placebo for 4 weeks of treatment. Change in sleeping quality which is the primary outcome of the study was assessed using the Pittsburgh sleep quality index (PSQI) scale. Linear mixed models were used to statistically analyze the difference in scores before and after 4 weeks of treatment. There was a reduction in the global PSQI score in both groups with no significant drug effect between groups. In conclusion, the use of melatonin (5 mg)/day didn’t differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment. However, higher doses are worth exploring in future research.

scholarly journals Naltrexone efficacy in treating alcohol-use disorder in individuals with comorbid psychosis: a systematic review

2017 ◽  
Vol 7 (8-9) ◽  
pp. 211-224 ◽  
Author(s):  
Martyna Sawicka ◽  
Derek K Tracy
Keyword(s):  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Evidence Base ◽  
Opioid Antagonist ◽  
Drinking Behaviour ◽  
Pharmaceutical Agent ◽  
Key Issues ◽  
Randomized Control ◽  
Long Acting ◽  
Study Designs

Background: Psychotic illnesses, such as schizophrenia, are typically enduring and disabling conditions, impacting individual, family, and societal outcomes. Individuals with these face greater vulnerabilities in developing alcohol-use disorder (AUD). Furthermore, the nature of psychoses, often manifesting with paranoia, cognitive impairment, a lack of insight, sub-optimal treatment adherence, and stigma from others, means that they can pose unique treatment challenges when these two conditions comorbidly occur. These challenges mean that the standard literature on the effectiveness of the opioid antagonist naltrexone in AUD does not necessarily translate to this vulnerable population. Methods: Following PRISMA guidelines, we herein systematically reviewed the evidence for naltrexone in individuals with both psychosis and AUD. Overall, there is a paucity of research in this important area, with only nine reports meeting search criteria, only four of which were randomized control trials. Studies compared naltrexone with: placebo, another pharmaceutical agent, or upon changes to baseline drinking behaviour. One study evaluated the long-acting injectable formulation of this drug. Results: Most studies, including the methodologically more robust ones, supported naltrexone’s effectiveness over placebo in terms of reduction in drinking days and numbers of drinks consumed on such days in this cohort. Work comparing naltrexone to other pharmaceutical interventions showed approximate equivalence with disulfiram, and modest superiority over acamprosate. Conclusions: On this limited evidence base, this review endorses the use of naltrexone as both safe and effective in those with both psychotic illnesses and AUD. Several key issues remain to be elucidated. Critically, study designs meant that they were limited to individuals with good engagement with services, and levels of adherence were attained that are unlikely to be replicated in this cohort in real-world settings. Finally, effects of specific psychosis symptomatology, not least paranoia and insight, upon naltrexone use, and the reverse directional potential of ‘double dysphoria’ from an opioid antagonist remain largely unexplored.

An open-label pilot study of quetiapine plus mirtazapine for heavy drinkers with alcohol use disorder

Alcohol ◽  
2016 ◽  
Vol 53 ◽  
pp. 45-50 ◽  
Author(s):  
Mary F. Brunette ◽  
Sarah C. Akerman ◽  
Ree Dawson ◽  
Christopher D. O'Keefe ◽  
Alan I. Green
Keyword(s):  
Pilot Study ◽  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Open Label ◽  
Heavy Drinkers

Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis

2006 ◽  
Vol 12 (5) ◽  
pp. 639-645 ◽  
Author(s):  
D T Wade ◽  
P M Makela ◽  
H House ◽  
C Bateman ◽  
P Robson
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Controlled Study ◽  
Open Label ◽  
Serious Adverse Events ◽  
Oral Pain ◽  
Acute Study ◽  
Based Medicine ◽  
Lost To Follow Up

The object of this study was to monitor the safety and efficacy of long-term use of an oromucosal cannabis-based medicine (CBM) in patients with multiple sclerosis (MS). A total of 137 MS patients with symptoms not controlled satisfactorily using standard drugs entered this open-label trial following a 10-week, placebo-controlled study. Patients were assessed every eight weeks using visual analogue scales and diary scores of main symptoms, and were followed for an average of 434 days (range: 21- 814). A total of 58 patients (42.3%) withdrew due to lack of efficacy (24); adverse events (17); withdrew consent (6); lost to follow-up (3); and other (8). Patients reported 292 unwanted effects, of which 251 (86%) were mild to moderate, including oral pain (28), dizziness (20), diarrhoea (17), nausea (15) and oromucosal disorder (12). Three patients had five ‘serious adverse events’ between them - two seizures, one fall, one aspiration pneumonia, one gastroenteritis. Four patients had first-ever seizures. The improvements recorded and dosage taken in the acute study remained stable. Planned, sudden interruption of CBM for two weeks in 25 patients (of 62 approached) did not cause a consistent withdrawal syndrome, although 11 (46%) patients reported at least one of - tiredness, interrupted sleep, hot and cold flushes, mood alteration, reduced appetite, emotional lability, intoxication or vivid dreams. Twenty-two (88%) patients re-started CBM treatment. We conclude that long-term use of an oromucosal CBM (Sativex) maintains its effect in those patients who perceive initial benefit. The precise nature and rate of risks with long-term use, especially epilepsy, will require larger and longer-term studies.

scholarly journals Emotional and Cognitive Improvement with Kirtan Kriya Meditation: A Pilot Study for Mild Cognitive Impairment Patients in a Catalan community.

2019 ◽  
Author(s):  
Toni Cañete ◽  
Gloria Borras Boneu ◽  
Silvia Ramos ◽  
Dharma Singh Khalsa
Keyword(s):  
Training Program ◽  
Cognitive Training ◽  
Intervention Program ◽  
Negative Mood ◽  
Cognitive Status ◽  
Controlled Study ◽  
Open Label ◽  
Cognitive Improvement ◽  
Yoga Class ◽  
Before And After

Objective: To study the effects of Kirtan Kriya Meditation (KKM) and 8-week yoga program on emotional and cognitive status, in MCI patients from our population, while undergoing cognitive training program (CTP).Design: We recruited 21 MCI adults GDS 3, for an open label non-randomized controlled study, but only 15 followed up. None had previous experience of meditation or yoga. Evaluation before and after the 8-week program was done by validated standard MCI tests. Seven patients practiced KKM for 12 minutes every day, weekly yoga session, and the standard cognitive training program while 8 patients only followed the cognitive training program (CTP).Results: The baseline negative mood and cognitive parameters became normal after the 8-week intervention program for the KKM group, decreasing tension, hostility, confusion and total PEA mood values (p<0.05). Depression and anxiety levels were also reduced to normal Goldberg score values. Similarly, the FCRST memory test showed higher memory scores for total free recall memory and TMT Trail-A test, moving to a normal range.Conclusions: The KKM group improved their psycho-emotional and cognitive health compared to CTP group. The yoga class elevated the perception of wellbeing. Further randomized studies are needed with a larger sample of MCI-diagnosed adults.

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