ClinicalTrials.gg
Not yet recruitingNCT06921278DARHTUpdated Apr 10, 2025

Development of the Drug and Alcohol Respiratory Health Test

An observational study in Respiratory Disease, Substance-Related Disorders and COPD, sponsored by King's College London. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.

Primary conditionSleep Apnea, ObstructiveRegistry: Respiration DisordersReclassifiedWhy we changed it
Registry
Respiration Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Sleep Apnea, Obstructive
Why
  1. The study's listed conditions name Sleep Apnea, Obstructive, a narrower term within Respiration Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by King's College London · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
260
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Respiratory Disease
  • Substance-Related Disorders
  • COPD
  • Asthma
  • Lung Cancer
  • Tuberculosis
  • Bronchitis
  • Pneumonia
  • Obstructive Sleep Apnea
03

In context

Sleep Apnea, Obstructive Reclassified

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 260 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.

Compared within Sleep Apnea, Obstructive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiration Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Addictions Community Centre for those suffering from substance-related disorders who may also have underlying respiratory diseases.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Reported physical health condition that would mean spirometry - 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
260 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. A brief respiratory health screening questionnaire

    To investigate the accuracy of a brief respiratory health screening questionnaire in highlighting respiratory health symptoms in participants with Substance Use Disorders.

    Time frame: Day 1 and Day 3-7

Secondary outcomes

  1. Specialist nurse and psychology assistant delivered Lung Health Clinic

    Evaluate 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.

    Time frame: Week 1 to Week 6

07

Study locations

1 site
  • South London & Maudsley NHS Trust
    London, BR3 3BX, United Kingdom
    • Mike Kelleher, MD · Contactmike.kelleher@slam.nhs.uk · 44 020 3228 1500
    • John Marsden, B.Sc., M.Sc., PhD, PgDiP CBT · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06921278
Collaborators
South London and Maudsley NHS Foundation Trust
Responsible party
Sponsor
First posted
Apr 10, 2025
Start date
Apr 15, 2025 (estimated)
Primary completion
Nov 11, 2025 (estimated)
Completion
Nov 11, 2025 (estimated)
Last update
Apr 10, 2025

Study contacts

John Marsden, B.Sc., M.Sc., PhD, PgDiP CBT
Contact
john.marsden@kcl.ac.uk
+44 02078365454
Francesca Small, Msc
Contact
francesca.a.small@kcl.ac.uk
+ 44 020 3228 1500

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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