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1.
J Clin Med ; 11(12)2022 Jun 07.
Article in English | MEDLINE | ID: mdl-35743326

ABSTRACT

The profound economic burden of schizophrenia is due, in part, to the negative symptoms of the disease, which can severely limit daily functioning. There is much debate in the field regarding their measurement and classification and there are no FDA-approved treatments for negative symptoms despite an abundance of research. 3,4-Methylenedioxy methamphetamine (MDMA) is a schedule I substance that has emerged as a novel therapeutic given its ability to enhance social interactions, generate empathy, and induce a state of metaplasticity in the brain. This review provides a rationale for the use of MDMA in the treatment of negative symptoms by reviewing the literature on negative symptoms, their treatment, MDMA, and MDMA-assisted therapy. It reviews recent evidence that supports the safe and potentially effective use of MDMA to treat negative symptoms and concludes with considerations regarding safety and possible mechanisms of action.

2.
Front Neurol ; 12: 685085, 2021.
Article in English | MEDLINE | ID: mdl-34393973

ABSTRACT

Objective: Stroke and traumatic brain injury (TBI) are among the leading causes of disability. Even after engaging in rehabilitation, nearly half of patients with severe TBI requiring hospitalization are left with major disability. Despite decades of investigation, pharmacologic treatment of brain injury is still a field in its infancy. Recent clinical trials have begun into the use of psychedelic therapeutics for treatment of brain injury. This brief review aims to summarize the current state of the science's relevance to neurorehabilitation, and may act as a resource for those seeking to understand the precedence for these ongoing clinical trials. Methods: Narrative mini-review of studies published related to psychedelic therapeutics and brain injury. Results: Recent in vitro, in vivo, and case report studies suggest psychedelic pharmacotherapies may influence the future of brain injury treatment through modulation of neuroinflammation, hippocampal neurogenesis, neuroplasticity, and brain complexity. Conclusions: Historical data on the safety of some of these substances could serve in effect as phase 0 and phase I studies. Further phase II trials will illuminate how these drugs may treat brain injury, particularly TBI and reperfusion injury from stroke.

3.
Psychopharmacology (Berl) ; 238(2): 581-588, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33221932

ABSTRACT

RATIONALE: MDMA-assisted psychotherapy is under investigation as a novel treatment for posttraumatic stress disorder (PTSD). The primary mechanism of action of MDMA involves the same reuptake transporters targeted by antidepressant medications commonly prescribed for PTSD. OBJECTIVES: Data were pooled from four phase 2 trials of MDMA-assisted psychotherapy. To explore the effect of tapering antidepressant medications, participants who had been randomized to receive active doses of MDMA (75-125 mg) were divided into two groups (taper group (n = 16) or non-taper group (n = 34)). METHODS: Between-group comparisons were made for PTSD and depression symptom severity at the baseline and the primary endpoint, and for peak vital signs across two MDMA sessions. RESULTS: Demographics, baseline PTSD, and depression severity were similar between the taper and non-taper groups. At the primary endpoint, the non-taper group (mean = 45.7, SD = 27.17) had a significantly (p = 0.009) lower CAPS-IV total scores compared to the taper group (mean = 70.3, SD = 33.60). More participants in the non-taper group (63.6%) no longer met PTSD criteria at the primary endpoint than those in the taper group (25.0%). The non-taper group (mean = 12.7, SD = 10.17) had lower depression symptom severity scores (p = 0.010) compared to the taper group (mean = 22.6, SD = 16.69). There were significant differences between groups in peak systolic blood pressure (p = 0.043) and diastolic blood pressure (p = 0.032). CONCLUSIONS: Recent exposure to antidepressant drugs that target reuptake transporters may reduce treatment response to MDMA-assisted psychotherapy.


Subject(s)
Antidepressive Agents/administration & dosage , Drug Tapering , N-Methyl-3,4-methylenedioxyamphetamine/administration & dosage , Neurotransmitter Uptake Inhibitors/administration & dosage , Psychotherapy/methods , Stress Disorders, Post-Traumatic/drug therapy , Adult , Antidepressive Agents/therapeutic use , Clinical Trials, Phase II as Topic , Combined Modality Therapy , Double-Blind Method , Female , Humans , Male , Middle Aged , Neurotransmitter Uptake Inhibitors/therapeutic use , Psychiatric Status Rating Scales , Randomized Controlled Trials as Topic , Treatment Outcome
4.
Lancet Psychiatry ; 5(6): 486-497, 2018 06.
Article in English | MEDLINE | ID: mdl-29728331

ABSTRACT

BACKGROUND: Post-traumatic stress disorder (PTSD) is prevalent in military personnel and first responders, many of whom do not respond to currently available treatments. This study aimed to assess the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treating chronic PTSD in this population. METHODS: We did a randomised, double-blind, dose-response, phase 2 trial at an outpatient psychiatric clinic in the USA. We included service personnel who were 18 years or older, with chronic PTSD duration of 6 months or more, and who had a Clinician-Administered PTSD Scale (CAPS-IV) total score of 50 or greater. Using a web-based randomisation system, we randomly assigned participants (1:1:2) to three different dose groups of MDMA plus psychotherapy: 30 mg (active control), 75 mg, or 125 mg. We masked investigators, independent outcome raters, and participants until after the primary endpoint. MDMA was administered orally in two 8-h sessions with concomitant manualised psychotherapy. The primary outcome was mean change in CAPS-IV total score from baseline to 1 month after the second experimental session. Participants in the 30 mg and 75 mg groups subsequently underwent three 100-125 mg MDMA-assisted psychotherapy sessions in an open-label crossover, and all participants were assessed 12 months after the last MDMA session. Safety was monitored through adverse events, spontaneously reported expected reactions, vital signs, and suicidal ideation and behaviour. This study is registered with ClinicalTrials.gov, number NCT01211405. FINDINGS: Between Nov 10, 2010, and Jan 29, 2015, 26 veterans and first responders met eligibility criteria and were randomly assigned to receive 30 mg (n=7), 75 mg (n=7), or 125 mg (n=12) of MDMA plus psychotherapy. At the primary endpoint, the 75 mg and 125 mg groups had significantly greater decreases in PTSD symptom severity (mean change CAPS-IV total scores of -58·3 [SD 9·8] and -44·3 [28·7]; p=0·001) than the 30 mg group (-11·4 [12·7]). Compared with the 30 mg group, Cohen's d effect sizes were large: 2·8 (95% CI 1·19-4·39) for the 75 mg group and 1·1 (0·04-2·08) for the 125 mg group. In the open-label crossover with full-dose MDMA (100-125 mg), PTSD symptom severity significantly decreased in the group that had previously received 30 mg (p=0·01), whereas no further significant decreases were observed in the group that previously achieved a large response after 75 mg doses in the blinded segment (p=0·81). PTSD symptoms were significantly reduced at the 12-month follow-up compared with baseline after all groups had full-dose MDMA (mean CAPS-IV total score of 38·8 [SD 28·1] vs 87·1 [16·1]; p<0·0001). 85 adverse events were reported by 20 participants. Of these adverse events, four (5%) were serious: three were deemed unrelated and one possibly related to study drug treatment. INTERPRETATION: Active doses (75 mg and 125 mg) of MDMA with adjunctive psychotherapy in a controlled setting were effective and well tolerated in reducing PTSD symptoms in veterans and first responders. FUNDING: Multidisciplinary Association for Psychedelic Studies.


Subject(s)
Firefighters/statistics & numerical data , N-Methyl-3,4-methylenedioxyamphetamine/therapeutic use , Psychotherapy/methods , Stress Disorders, Post-Traumatic/therapy , Veterans/statistics & numerical data , Adult , Dose-Response Relationship, Drug , Double-Blind Method , Firefighters/psychology , Humans , Police/psychology , Psychiatric Status Rating Scales/statistics & numerical data , Stress Disorders, Post-Traumatic/drug therapy , Treatment Outcome , Veterans/psychology , Young Adult
6.
Psychopharmacology (Berl) ; 235(2): 561-571, 2018 02.
Article in English | MEDLINE | ID: mdl-29152674

ABSTRACT

Pharmacotherapy is often used to target symptoms of posttraumatic stress disorder (PTSD), but does not provide definitive treatment, and side effects of daily medication are often problematic. Trauma-focused psychotherapies are more likely than drug treatment to achieve PTSD remission, but have high dropout rates and ineffective for a large percentage of patients. Therefore, research into drugs that might increase the effectiveness of psychotherapy is a logical avenue of investigation. The most promising drug studied as a catalyst to psychotherapy for PTSD thus far is 3,4-methylenedioxymethamphetamine (MDMA), commonly known as the recreational drug "Ecstasy." MDMA stimulates the release of hormones and neurochemicals that affect key brain areas for emotion and memory processing. A series of recently completed phase 2 clinical trials of MDMA-assisted psychotherapy for treatment of PTSD show favorable safety outcomes and large effect sizes that warrant expansion into multi-site phase 3 trials, set to commence in 2018. The nonprofit sponsor of the MDMA drug development program, the Multidisciplinary Association for Psychedelic Studies (MAPS), is supporting these trials to explore whether MDMA, administered on only a few occasions, can increase the effectiveness of psychotherapy. Brain imaging techniques and animal models of fear extinction are elucidating neural mechanisms underlying the robust effects of MDMA on psychological processing; however, much remains to be learned about the complexities of MDMA effects as well as the complexities of PTSD itself.


Subject(s)
Drug Development/trends , Hallucinogens/therapeutic use , Mental Disorders/drug therapy , Mental Disorders/psychology , N-Methyl-3,4-methylenedioxyamphetamine/therapeutic use , Affect/drug effects , Affect/physiology , Animals , Brain/drug effects , Brain/physiology , Clinical Trials, Phase II as Topic/methods , Drug Development/methods , Fear/drug effects , Fear/physiology , Fear/psychology , Hallucinogens/pharmacology , Humans , Illicit Drugs/pharmacology , Memory/drug effects , Memory/physiology , N-Methyl-3,4-methylenedioxyamphetamine/pharmacology , Neuroimaging/methods , Neuroimaging/trends , Psychotherapy/methods , Psychotherapy/trends , Stress Disorders, Post-Traumatic/drug therapy , Stress Disorders, Post-Traumatic/psychology
7.
Gynecol Oncol ; 143(2): 287-293, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27593736

ABSTRACT

BACKGROUND: Endometrial cancer (EC) is the most common gynaecological cancer in developed nations and its incidence is rising. As a direct consequence, more women are dying from EC despite advances in care and improved survivorship. There is a lack of research activity and funding, as well as public awareness about EC. We sought to engage patients, carers and healthcare professionals to identify the most important unanswered research questions in EC. METHODOLOGY: The priority setting methodology was developed by the James Lind Alliance and involved four key stages: gathering research questions; checking these against existing evidence; interim prioritisation; and a final consensus meeting during which the top ten unanswered research questions were agreed using modified nominal group methodology. RESULTS: Our first online survey yielded 786 individual submissions from 413 respondents, of whom 211 were EC survivors or carers, and from which 202 unique unanswered research questions were generated. 253 individuals, including 108 EC survivors and carers, completed an online interim prioritisation survey. The resulting top 30 questions were ranked in a final consensus meeting. Our top ten spanned the breadth of patient experience of this disease and included developing personalised risk scoring, refining criteria for specialist referral, understanding the underlying biology of different types of EC, developing novel personalised treatment and prevention strategies, prognostic and predictive biomarkers, increasing public awareness and interventions for psychological issues. CONCLUSION: Having established the top ten unanswered research questions in EC, we hope this galvanises researchers, healthcare professionals and the public to collaborate, coordinate and invest in research to improve the lives of women affected by EC.


Subject(s)
Biomedical Research , Endometrial Neoplasms/therapy , Adolescent , Adult , Aged , Aged, 80 and over , Caregivers , Cooperative Behavior , Endometrial Neoplasms/mortality , Female , Health Personnel , Humans , Middle Aged
8.
Hum Psychopharmacol ; 29(2): 105-8, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24590541

ABSTRACT

Parrott recently published a review of literature on MDMA/ecstasy. This commentary is a response to the content and tenor of his review, which mischaracterizes the literature through misstatement and omission of contrary findings, and fails to address the central controversies in the literature. The review makes several erroneous statements concerning MDMA-assisted psychotherapy, such as incorrect statements about research design and other statements that are baseless or contradicted by the literature. Though it critiques an attempt by other authors to characterize the risks of MDMA, the review fails to produce a competing model of risk assessment, and does not discuss potential benefits. Parrott does not represent an even-handed review of the literature, but instead recites dated misconceptions about neurotoxicity concerns involving the recreational drug ecstasy, which do not relate directly to the use of pure MDMA in a therapeutic setting. Unchallenged, Parrott's report may deter researchers from further investigating an innovative treatment that in early clinical trials has demonstrated lasting benefits for people with chronic, treatment-resistant post-traumatic stress disorder.


Subject(s)
Empirical Research , Hallucinogens/adverse effects , Illicit Drugs/adverse effects , Memory Disorders/psychology , N-Methyl-3,4-methylenedioxyamphetamine/adverse effects , Animals , Humans
9.
Nurs Econ ; 31(1): 41, 2013.
Article in English | MEDLINE | ID: mdl-23505744
10.
J Appl Psychol ; 94(4): 1003-17, 2009 Jul.
Article in English | MEDLINE | ID: mdl-19594240

ABSTRACT

The demands control support model (R. A. Karasek & T. Theorell, 1990) indicates that job control and social support enable workers to engage in problem solving. In turn, problem solving is thought to influence learning and well-being (e.g., anxious affect, activated pleasant affect). Two samples (N = 78, N = 106) provided data up to 4 times per day for up to 5 working days. The extent to which job control was used for problem solving was assessed by measuring the extent to which participants changed aspects of their work activities to solve problems. The extent to which social support was used to solve problems was assessed by measuring the extent to which participants discussed problems to solve problems. Learning mediated the relationship between changing aspects of work activities to solve problems and activated pleasant affect. Learning also mediated the relationship between discussing problems to solve problems and activated pleasant affect. The findings indicated that how individuals use control and support to respond to problem-solving demands is associated with organizational and individual phenomena, such as learning and affective well-being.


Subject(s)
Affect , Inservice Training , Internal-External Control , Job Satisfaction , Problem Solving , Social Support , Workload/psychology , Adaptation, Psychological , Adult , Computers, Handheld , Cooperative Behavior , Female , Humans , Male , Middle Aged , Organizational Culture , Personnel Management , Surveys and Questionnaires
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