scholarly journals “This Is Something That Changed My Life”: A Qualitative Study of Patients' Experiences in a Clinical Trial of Ketamine Treatment for Alcohol Use Disorders

2021 ◽  
Vol 12 ◽  
Author(s):  
O. Merve Mollaahmetoglu ◽  
Johanna Keeler ◽  
Katherine J. Ashbullby ◽  
Eirini Ketzitzidou-Argyri ◽  
Meryem Grabski ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Quantitative Research ◽  
Controlled Trial ◽  
Trial Participation ◽  
Therapeutic Effects ◽  
Structured Interviews ◽  
Double Blind ◽  
Therapeutic Benefits ◽  
Psychoactive Effects ◽  
Randomised Controlled

Background: The therapeutic benefits of ketamine have been demonstrated for a variety of psychiatric disorders. However, the role of ketamine induced psychoactive experiences in mediating the therapeutic effects is unclear. Despite the growing quantitative research on the efficacy of ketamine treatment, very few studies examined participant experiences of ketamine infusions in a treatment setting.Aims: The current study aimed to examine participant experiences of ketamine infusions and how these relate to therapeutic mechanisms in a clinical trial setting.Methods: We conducted semi-structured interviews with 12 participants who received up to three ketamine infusions (0.8 mg/kg) as part of a Phase II double blind, randomised controlled trial. The interviews explored participants' acute experiences of ketamine infusions, experiences of psychotherapy/education, and the lasting effects of the trial. The interviews were transcribed verbatim and analysed using thematic analysis.Results: Six key themes were identified. (1) Participants reported multifaceted motivations for trial participation. (2) The set and setting was found to be influential in determining acute ketamine experiences. The acute ketamine experiences included: (3) the inherent contradictions of the experience (e.g., dissociation vs feelings of connection), (4) rapidly fluctuating and changing experiences, (5) meaningful, mystical and spiritual experiences. Finally, the final theme (6) relates to the transformational effects of the infusions and the trial.Conclusion: Provided in a supportive and professional environment, ketamine treatment led to a significant change in relationship with alcohol. Ketamine induced ego dissolution and dissociation were reported to be related to the transformational effects on relationship with alcohol. The extent to which the acute psychoactive effects of ketamine mediate therapeutic effects on drinking outcomes remain to be investigated in the trial data. The acute effects of ketamine reported by our participants transcend its traditional conceptualisation as a “dissociative anaesthetic”; therefore, we suggest the development or use of new measures alongside ketamine infusions to fully capture the spectrum of these effects which may be crucial in its therapeutic and transformative effects.

scholarly journals Naoxuekang, Xinnaoshutong and Xuesaitong capsules for treating stroke: a protocol for a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e015983 ◽  
Author(s):  
Huiling Chen ◽  
Hongbo Cao ◽  
Xu Guo ◽  
Meidan Zhao ◽  
Qing Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Facial Paralysis ◽  
Controlled Trial ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Initial Treatment Period ◽  
Double Blind Clinical Trial ◽  
Registration Number ◽  
Index Value ◽  
Randomised Controlled

IntroductionAfter stroke, hemiplegia, dysphasia and facial paralysis can manifest during the convalescent period. Currently, no Chinese patent medicine (CPM) is previously reported to cure each of these symptoms primarily, and thus, there are no relevant instructions for the use of CPM. This study presents a new approach based on comparative effectiveness research to distinguish the curative effects of three CPMs that are often used in stroke convalescence to determine the ideal medicine for the treatment of each symptom.Methods and analysisIn this multicentre and double-blind clinical trial, stratified randomisation is used to group the patients according to their primary symptoms (hemiplegia, dysphasia and facial paralysis). Three strata will be enrolled, with 80 eligible participants included in each stratum. Each stratum will be randomly and equally divided into four groups, and each group will receive one of the following treatments: Naoxuekang, Xinnaoshutong (XNST), Xuesaitong (XST) or placebo. This study will include two stages: the initial treatment period (30 days) and a follow-up period (180 days). Three replicates for each data point will be completed during this trial. The first visit will occur on day 0 after enrolment, the second visit on day 30±2 and the third visit on day 210±5. The Delphi technique is adopted to achieve index weighting, which ensures that the evaluation outcome is patient oriented. The weighted index value will be computed as the final measurement index of the outcome.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of Tianjin University of Traditional Chinese Medicine (registration number TJUTCM-EC20160007). The results will be offered for publication in peer-reviewed journals.Trial registration numberThis trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17010397). The date of registration was 11 January 2017.

scholarly journals A double blind, randomised, placebo-controlled trial to evaluate the efficacy of metformin to treat preterm pre-eclampsia (PI2 Trial): study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e025809 ◽  
Author(s):  
Catherine Cluver ◽  
Susan P Walker ◽  
Ben W Mol ◽  
David Hall ◽  
Richard Hiscock ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Biological Effects ◽  
Controlled Trial ◽  
Disease Process ◽  
Major Complication ◽  
Definitive Treatment ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Randomised Controlled

IntroductionPre-eclampsia is a major complication of pregnancy, globally responsible for 60 000 maternal deaths per year, and far more fetal losses. There is no definitive treatment other than delivery. A therapeutic that could quench the disease process would be useful to treat preterm pre-eclampsia, as it could allow these pregnancies to safely continue to a gestation where fetal outcomes are significantly improved. We have published preclinical data to show that metformin, a drug known to be safe in pregnancy and commonly used to treat gestational diabetes, has potent biological effects making it another promising candidate to treat pre-eclampsia. Here, we describe a phase II clinical trial to examine whether administering extended-release metformin may be effective in treating women with preterm pre-eclampsia (PI2 Trial).MethodsThe PI2 Trial is a phase II, double blind, randomised controlled trial that aims to recruit 150 women with preterm pre-eclampsia (gestational age 26+0 to 31+6 weeks) who are being managed expectantly. Participants will be randomised to receive either 3 g of metformin or placebo daily. The primary outcome is time from randomisation until delivery. A delay in delivery of 5 days is assumed to be clinically relevant. The secondary outcomes will be a maternal composite and neonatal composite outcome. All other outcomes will be exploratory. We will record adverse events.Ethics and disseminationThis study has ethical approval (Protocol number M16/09/037 Federal Wide Assurance Number 00001372, Institutional Review Board Number IRB0005239), is registered with the Pan African Clinical Trial Registry (PACTR201608001752102) and the South African Medicine Control Council (20170322). Data will be presented at international conferences and published in peer-reviewed journals.Trial registration numberPACTR201608001752102; Pre-results.

A Controlled Trial of the Therapeutic Effects of Polarization of the Brain in Depressive Illness

1964 ◽  
Vol 110 (469) ◽  
pp. 786-799 ◽  
Author(s):  
R. Costain ◽  
J. W. T. Redfearn ◽  
O. C. J. Lippold
Keyword(s):  
Clinical Trial ◽  
Human Subjects ◽  
Controlled Trial ◽  
Depressive Illness ◽  
Therapeutic Effects ◽  
Double Blind ◽  
Beneficial Effects ◽  
Double Blind Clinical Trial ◽  
The Brain

A previous paper (Lippold and Redfearn, 1964) described various mental changes which occur when small direct currents are passed through the brain in human subjects. Some beneficial effects often followed this procedure and it appeared worthwhile to carry out a controlled double-blind clinical trial.

scholarly journals ‘It's trying to manage the work’: a qualitative evaluation of recruitment processes within a UK multicentre trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016475 ◽  
Author(s):  
Zoë Christina Skea ◽  
Shaun Treweek ◽  
Katie Gillies
Keyword(s):  
Clinical Trial ◽  
Multicentre Trial ◽  
Controlled Trial ◽  
Qualitative Evaluation ◽  
Therapeutic Interventions ◽  
Structured Interviews ◽  
Patient Identification ◽  
Trial Site ◽  
Randomised Controlled ◽  
The Uk

ObjectivesTo explore trial site staff's perceptions regarding barriers and facilitators to local recruitment.DesignQualitative semi-structured interviews with a range of trial site staff from four trial sites in the UK. Interviews were analysed thematically to identify common themes across sites, barriers that could be addressed and facilitators that could be shared with other sites.Participants11 members of staff from four trial sites: clinical grant Co-applicant (n=1); Principal Investigators (n=3); Consultant Urologist (n=1); Research Nurses (n=5); Research Assistant (n=1).SettingEmbedded within an ongoing randomised controlled trial (the TISU trial). TISU is a UK multicentre trial comparing therapeutic interventions for ureteric stones.ResultsOur study draws attention to the initial and ongoing burden of trial work that is involved throughout the duration of a clinical trial. In terms of building and sustaining a research culture, trial staff described the ongoing work of engagement that was required to ensure that clinical staff were both educated and motivated to help with the process of identifying and screening potential participants. Having adequate and sufficient organisational and staffing resources was highlighted as being a necessary prerequisite to successful recruitment both in terms of accessing potentially eligible patients and being able to maximise recruitment after patient identification. The nature of the research study design can also potentially generate challenging communicative work for recruiting staff which can prove particularly problematic.ConclusionsOur paper adds to existing research highlighting the importance of the hidden and complex work that is involved in clinical trial recruitment. Those designing and supporting the operationalisation of clinical trials must recognise and support the mitigation of this ‘work’. While much of the work is likely to be contextually sensitive at the level of local sites and for individual trials, some aspects are ubiquitous issues for delivery of trials more generally.Trial registration numberISRCTN No 92289221; Pre-results.

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