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NCT Number: NCT07482150

The Connect Trial: Connecting Hospital Patients to Alcohol Care

The main objective of this pilot study is to assess feasibility of conducting a definitive RCT with concealed allocation, blinded outcome assessment and a 1:1 parallel group design of A) an invitation to meet an AUD therapist for up to 10 treatment sessions at the hospital in up to 6 months (intervention) compared to B) guidance on how to seek alcohol care in an AUD treatment centre in the community, outside of the hospital (control).

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zealand University Hospital, Department of Medicine

Køge, 4600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalised or seen in an outpatient clinic at SUH Køge
  • Full-filling international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use
  • Informed written consent
  • Being able to meet the AUD therapist in connection with a hospital visit with a health condition wholly or partly attributable to alcohol

Exclusion criteria

  • Ongoing specialized treatment for AUD
  • Not speaking Danish
  • Not living in the catchment area of Zealand University hospital
  • Age < 18 years
  • Enrolled in the Zealand alcohol-related liver disease cohort study

Treatment and study plan

AUD treatment sessions with an outreach alcohol therapist at the hospital

Other

Participants will be offered an AUD treatment session at the hospital the same or next day as they are enrolled in the study with an outreach alcohol therapist from a local AUD treatment facility. The alcohol therapist will be trained in motivational interviewing and cognitive behavioural therapy for AUD. The session will aim to motivate patients to reduce their alcohol consumption and set goals for AUD treatment. The alcohol therapist can recommend a medical therapy to support alcohol reduction or abstinence - this prescription will be undertaken by a hepatologist from the Department of Medicine and may be continued after discharge by patients´ general practitioner or physicians at the AUD treatment facility. Up to 10 sessions of up to 60 minutes of duration at the hospital during 6 months after the baseline visit can be offered and after that, the participant can continue to meet with the same therapist in the community.

Guidance and leaflet on AUD treatment facilities outside the hospital

Other

Participants randomised as controls will be offered a leaflet informing about different possibilities for alcohol misuse treatments and guidance on how to approach them (may include referral or help with doing an appointment, if possible according to the specific treatment center) in the catchment area of SUH Køge and Roskilde

Primary outcomes

  1. Recruitment

    Time frame: 6 months

    >50% of eligible individuals invited to the study give written informed consent

  2. Retention

    Time frame: 6 months

    >50% individuals recruited and randomized to the intervention, will attend to the intervention of seing the AUD therapist at least once

  3. Completion

    Time frame: 6 months

    >50% of all randomized study participants complete the follow-up interview and blood sample

Secondary outcomes

  1. AUD treatment engagement after 6 and 12 months

    Time frame: 12 months

    No predefined goal

  2. Mortality after 6 and 12 months

    Time frame: 12 months

    No predefined goal

  3. Change in drinks (containing 12 g ethanol) per last 30 days from baseline till 6 months after inclusion

    Time frame: 6 months

  4. Proportion with abstinence or light drinking (<10 drinks/week) last 30 days

    Time frame: 6 months

    yes or no

  5. Change in blood phosphatidyl ethanol level from baseline to 6 months after inclusion

    Time frame: 6 months

  6. Change in motivation to cut down on alcohol (yes or no), calculated as the difference between baseline and 6 months follow-up

    Time frame: 6 months

  7. Number of AUD treatment sessions

    Time frame: 6 months

  8. Proportion initiating medical AUD therapy

    Time frame: 6 months

  9. Proportion receiving medical AUD treatment at 6- and 12 months follow up

    Time frame: 12 months

  10. Number of acute hospital admissions or emergency room visits at 6 and 12 months

    Time frame: 12 months

  11. Number of hospital outpatient visits at 6 and 12 months

    Time frame: 12 months

  12. 3- year follow-up, conducted through health care registries and AUD treatment facilities to look for incidence of alcohol-related morbidity and mortality, visits to general practitioner and hospital contacts

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Gro Askgaard, MD, PhD

CONTACT

[email protected]

60142280

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

The Connect Trial: Connecting Hospital Patients to Alcohol Care - a Randomized Controlled Feasibility Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2031
First posted
Mar 19, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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