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Development of the Drug and Alcohol Respiratory Health Test

Psychometric Development of the Alcohol and Drug Respiratory Health Questionnaire and Evaluation of a Lung Health Clinic

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06921278
Acronym
DARHT
Enrollment
260
Registered
2025-04-10
Start date
2025-04-15
Completion date
2025-11-11
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchitis, COPD, Lung Cancer, Obstructive Sleep Apnea, Pneumonia, Respiratory Disease, Substance-Related Disorders, Tuberculosis

Brief summary

The goal of this study is to develop a brief Drug and Alcohol Respiratory Health Test (DARHT) and offer it for routine use in clinical assessment and medical reviews

Detailed description

Respiratory diseases are highly prevalent among adults with substance use disorder. Inhaling drugs are risk factors, and cigarette smoking contributes to 90% of COPD cases. The substance use disorders population faces barriers to accessing healthcare, leading to under-diagnosis and including stigma, exacerbating the unmet need for effective respiratory disease management. There is no population-specific screening instrument in NHS and Third Sector addiction services. The lack of a validated screening tool means Respiratory health symptoms may be overlooked or attributed to other causes. The aim of this trial is to develop a brief Drug and Alcohol Respiratory Health Test (DARHT) and make it available for clinical assessment and medical reviews. The primary research question is to determine if the DARHT achieves satisfactory diagnostic accuracy with gold-standard spirometry. The study will be open to any enrolled adult (age \>18 years) patients at our treatment clinic (NHS secondary care) who reports inhaling (smoking) tobacco, cannabis, cocaine, opioids, or consuming alcohol in the past 28 days. Volunteer and informed and consenting participants will be invited to: (1) complete a brief study questionnaire that includes the DARHT, then take a spirometry and pulse oximetry test; (2) return to the clinic after 3-7 day to complete the DARHT with a different interviewer. Participants with a positive case evaluation on the DARHT or spirometer will be referred to primary or specialist services. The investigators will contact participants referred after 6 weeks to determine their progress and the PHQ-4 and EQ-5D-L to evaluate changes in quality of life. The first 20 participants referred to specialist care will be invited to a Lung Health Clinic where the investigators will offer a psycho-social intervention for advice and support.

Interventions

None listed

Sponsors

South London and Maudsley NHS Foundation Trust
CollaboratorOTHER
King's College London
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. \>18 (no upper age limit) 2. Inhalation (smoking) of tobacco, or cannabis, or cocaine, or opioids, or use of alcohol in the past 28 days 3. Possession of a personal mobile phone to arrange follow-up appointments

Exclusion criteria

1. Reported physical health condition that would mean spirometry contra-indicated - including heart attack, unstable angina, pulmonary embolism, 2. Reported surgery in the past 3 months for an eye, chest, or abdominal condition that would mean spirometry contra-indicated 3. Likely inability to complete study due to criminal justice involvement with legal proceedings risking incarceration

Design outcomes

Primary

MeasureTime frameDescription
A brief respiratory health screening questionnaireDay 1 and Day 3-7To investigate the accuracy of a brief respiratory health screening questionnaire in highlighting respiratory health symptoms in participants with Substance Use Disorders.

Secondary

MeasureTime frameDescription
Specialist nurse and psychology assistant delivered Lung Health ClinicWeek 1 to Week 6Evaluate the effectiveness of a specialist nurse and psychology assistant delivered by the Lung Health Clinic in improving respiratory health referrals, airway medication updates and adherence, service satisfaction, and quality of life.

Countries

United Kingdom

Contacts

Primary ContactJohn Marsden, B.Sc., M.Sc., PhD, PgDiP CBT
john.marsden@kcl.ac.uk+44 02078365454
Backup ContactFrancesca Small, Msc
francesca.a.small@kcl.ac.uk+ 44 020 3228 1500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026