Development of the Drug and Alcohol Respiratory Health Test

NCT ID: NCT06921278

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-11-11

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

South London & Maudsley NHS Trust

London, , United Kingdom

Countries

United Kingdom

Central Contacts

John Marsden, B.Sc., M.Sc., PhD, PgDiP CBT

Role: CONTACT

john.marsden@kcl.ac.uk

+44 02078365454

Francesca Small, Msc

Role: CONTACT

francesca.a.small@kcl.ac.uk

+ 44 020 3228 1500

Facility Contacts

Mike Kelleher, MD

Role: primary

mike.kelleher@slam.nhs.uk

44 020 3228 1500

Other Identifiers

DARHT

Identifier Type: -

Identifier Source: org_study_id