Respiratory DiseaseDARHTNCT06921278
Development of the Drug and Alcohol Respiratory Health Test
An observational study of Respiratory Disease and Substance-Related Disorders, run by King's College London at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Disease, Substance-Related Disorders, COPD
- How many people
- 260 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2025to 11 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Addictions Community Centre for those suffering from substance-related disorders who may also have underlying respiratory diseases.
Who may be able to join
- >18 (no upper age limit)
- Inhalation (smoking) of tobacco, or cannabis, or cocaine, or opioids, or use of alcohol in the past 28 days
- Possession of a personal mobile phone to arrange follow-up appointments
Who cannot join
- Reported physical health condition that would mean spirometry contra-indicated - including heart attack, unstable angina, pulmonary embolism,
- Reported surgery in the past 3 months for an eye, chest, or abdominal condition that would mean spirometry contra-indicated
- Likely inability to complete study due to criminal justice involvement with legal proceedings risking incarceration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
South London & Maudsley NHS Trust
London, BR3 3BX
Mike Kelleher, MD, 44 020 3228 1500, mike.kelleher@slam.nhs.uk
John Marsden, B.Sc., M.Sc., PhD, PgDiP CBT
About this study
Official title: Psychometric Development of the Alcohol and Drug Respiratory Health Questionnaire and Evaluation of a Lung Health Clinic
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.
- Conditions
- Respiratory Disease, Substance-Related Disorders, COPD, Asthma, Lung Cancer, Tuberculosis
- Medical subject headings
- Respiration Disorders, Substance-Related Disorders, Pulmonary Disease, Chronic Obstructive, Asthma, Lung Neoplasms, Tuberculosis, Bronchitis, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 1 to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion11 Nov 2025 (estimated)
- Study completion11 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921278
- Sponsor's protocol ID
- DARHT
- Acronym
- DARHT
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Development of the Alcohol and Drug Respiratory Health Questionnaire and Evaluation of a Lung Health Clinic
- ClinicalTrials.gov ID
- NCT06921278
- Acronym / sponsor ID
- DARHT / DARHT
- Conditions
- Respiratory Disease, Substance-Related Disorders, COPD, Asthma, Lung Cancer, Tuberculosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 11 Nov 2025 (estimated)
- Study completion
- 11 Nov 2025 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Addictions Community Centre for those suffering from substance-related disorders who may also have underlying respiratory diseases.
Key inclusion criteria (3 listed)
- >18 (no upper age limit)
- Inhalation (smoking) of tobacco, or cannabis, or cocaine, or opioids, or use of alcohol in the past 28 days
- Possession of a personal mobile phone to arrange follow-up appointments
Key exclusion criteria (3 listed)
- Reported physical health condition that would mean spirometry contra-indicated - including heart attack, unstable angina, pulmonary embolism,
- Reported surgery in the past 3 months for an eye, chest, or abdominal condition that would mean spirometry contra-indicated
- Likely inability to complete study due to criminal justice involvement with legal proceedings risking incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A brief respiratory health screening questionnaire
Time frame: Day 1 and Day 3-7
To investigate the accuracy of a brief respiratory health screening questionnaire in highlighting respiratory health symptoms in participants with Substance Use Disorders.
1 secondary outcome
Specialist nurse and psychology assistant delivered Lung Health Clinic
Time frame: Week 1 to Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease and Substance-Related Disorders, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Marsden, B.Sc., M.Sc., PhD, PgDiP CBT (+44 02078365454, john.marsden@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A brief respiratory health screening questionnaire (time frame: Day 1 and Day 3-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.