NCT07716293

Brief Summary

Nitrous oxide (laughing gas, N₂O) is the third most commonly used recreational drug among young people in the UK. Although it may seem harmless, frequent use can damage the nerves and spinal cord. Vitamin B12 injections can help treat these neurological complications, but continued N₂O use can reduce how effective this treatment is. Some people use N₂O to cope with stress or emotional difficulties, while others may find it hard to stop because of cravings or habits. These emotional and social difficulties can negatively affect recovery, wellbeing, and quality of life. Our team has developed a new brief support programme for people experiencing mild to moderate emotional and social difficulties related to N₂O use. The programme provides information and practical strategies to help people cope, manage emotions, and prevent problems from worsening. It is delivered by a trained facilitator over up to four weekly sessions, either in-person or remotely. In this study, the support programme will be introduced to patients attending the Royal London Hospital clinic for N₂O related neurological harms. Ten participants will receive the programme alongside their usual care. Participants will complete questionnaires before and after the programme to monitor mental health, quality of life, and dependence on N₂O. The research team will evaluate whether the programme was delivered as intended and whether participants remained engaged. Participants will be invited to take part in an interview to feedback on their experiences and suggest improvements before the programme is tested in a larger study. Participation will last up to 8 hours in total over approximately 9 weeks.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 14, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 1, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Feasibility studyMixed methodsNitrous oxidePsychological interventionAddiction and dependence

Outcome Measures

Primary Outcomes (3)

  • Feasibility response rate

    Response rates

    12 months

  • Feasibility uptake

    Study uptake

    12 months

  • Feasibility drop out

    Drop outs and completion

    12 months

Secondary Outcomes (3)

  • Fidelity accuracy

    12 months

  • Fidelity quality

    12 months

  • Acceptability

    12 months

Study Arms (1)

Psychosocial intervention

EXPERIMENTAL

A brief manualised psychosocial intervention comprising information provision, psychoeducation, goal setting, coping strategies, self-management strategies, and Cognitive Behavioural Therapy techniques (Inc. Mindfulness, cognitive reframing). The intervention will be tailored to individual needs, informed by questionnaire results, goal setting, homework activities, and open discussion.

Behavioral: Psychosocial intervention

Interventions

A brief manualised psychosocial intervention comprising information provision, psychoeducation, goal setting, coping strategies, self-management strategies, and Cognitive Behavioural Therapy techniques (Inc. Mindfulness, cognitive reframing). The intervention will be tailored to individual needs, informed by questionnaire results, goal setting, homework activities, and open discussion.

Psychosocial intervention

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed clinical neurological diagnosis related to N₂O use.
  • Experiencing mild to moderate psychological distress.
  • Aged 16-65 years.
  • Able to communicate in English.
  • Able and willing to give informed consent.

You may not qualify if:

  • Other causes of neurological symptoms.
  • Currently receiving another structured psychosocial intervention.
  • Severe psychiatric distress.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary University of London

London, E1 4NS, United Kingdom

Location

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Laura Smith, PhD, PGCHE, MSc, BSc

CONTACT

Alastair Noyce

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A brief manualised psychosocial intervention comprising information provision, psychoeducation, goal setting, coping strategies, self-management strategies, and Cognitive Behavioural Therapy techniques (Inc. Mindfulness, cognitive reframing). The intervention will be tailored to individual needs, informed by questionnaire results, goal setting, homework activities, and open discussion.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 21, 2026

Study Start (Estimated)

September 14, 2026

Primary Completion (Estimated)

August 13, 2027

Study Completion (Estimated)

September 13, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Patient data only collected for the purpose of this study.

Locations