NCT05714917 Neurological Recovery Following NOS-SACD
| NCT ID | NCT05714917 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nottingham University Hospitals NHS Trust |
| Condition | Nitrous Oxide Abuse |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-19 |
| Primary Completion | 2026-08-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-08-19 with a primary completion date of 2026-08-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Nitrous oxide has become an increasingly popular recreational drug amongst young people, particularly at festivals, nightclubs and parties. Considering the drug is not illegal to possess, has low cost in the form of 'whippets' and can be easily purchased online, it has become the second most commonly used recreational drug amongst people aged 16-24 in the UK. However, nitrous oxide is known to irreversibly inactivate the functioning of vitamin B12, a vitamin required for the maintenance and proper functioning of nerves in the spinal cord. Neurological symptoms in this population have been reported in around 3.4% of nitrous oxide users, although the true incidence is expected to be higher as the cases being reported by UK hospitals continues to rise. Patients may present with adverse neurological symptoms like tingling, weakness, coordination and mobility problems. Currently, studies reviewing the functional recovery of these patients have been limited by a retrospective study design, short follow up duration and being limited to small cohort sizes. This is in part linked to patient non-compliance and non-attendance at follow-up appointments. The investigators will therefore prospectively recruit all patients presenting with these symptoms and continue to collect data relating to their neurological recovery for 12 months. Data collection will be remote to ensure it is of low burden to the participants. This will allow the investigating team and others to fully appraise the severity of these toxic neuropathies and understand how best to manage their follow up.
Eligibility Criteria
Inclusion Criteria: * Any patient first presented with paraesthesia, weakness, ataxia or gait disturbance with a history of NOS use (age limit 16-40) as of 19/08/2024 * Patients who can read and write in English, so that they can complete the questionnaires. * Patients must have received a definitive consultant neurologist confirmed diagnosis of NOS-induced neurological damage. This is possible as all eligible patients will have been reviewed by the neurology team prior to study involvement. Exclusion Criteria: •Other causes of previous neuropathy or neurodegeneration indicated. Qualitative Interview Study: * Patients currently taking part in the longitudinal study. * Patients who report previously (clinical history) or currently (PHQ-2, clinical history) experiencing mental health difficulties.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05714917 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 40 Years, studying Nitrous Oxide Abuse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05714917 currently recruiting?
Yes, NCT05714917 is actively recruiting participants. Contact the research team at nikos.evangelou@nottingham.ac.uk for enrollment information.
Where is the NCT05714917 trial being conducted?
This trial is being conducted at Birmingham, United Kingdom, London, United Kingdom, Manchester, United Kingdom.
Who is sponsoring the NCT05714917 clinical trial?
NCT05714917 is sponsored by Nottingham University Hospitals NHS Trust. The trial plans to enroll 100 participants.