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Active, Not Recruiting

NCT Number: NCT05916027

Identification and Treatment of Alcohol Problems in Primary Care

The Identification and Treatment of Alcohol Problems in Primary Care (iTAPP) Study is a pragmatic cluster randomized controlled intervention trial evaluating the effectiveness of the 15-Method as an identification and treatment tool for alcohol-related problems in Danish general practice. The 15-Method combines evidence-based approaches from specialized addiction treatment with screening and readily available treatment options in general practice to help identify and treat alcohol problems in a primary care setting. The method has shown promising results as a treatment tool in Sweden. A feasibility study of the 15-Method in Denmark suggested that the method can be implemented in Danish general practice.

The trial is led by the Unit for Clinical Alcohol Research at The University of Southern Denmark in collaboration with The Research Unit of General Practice Odense at The University of Southern Denmark.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol Abuse Alcoholism Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders General Practice Mental Disorders Screening and Brief Intervention Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark

Odense C, Fynen, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years or older
  • Affiliated with the participating general practices

Exclusion criteria

  • None

Treatment and study plan

The 15-Method

Behavioral

The 15-Method is a Screening and Brief Intervention method for identifying and treating alcohol problems in primary care. The method combines evidence-based approaches from specialized addiction treatment with screening and readily available treatment options in general practice to help identify and treat alcohol problems. The 15-method is based on Motivational Interviewing, Cognitive Behavioral Therapy and utilizes the Alcohol Use Disorder Identification Test (AUDIT) as a screening tool. The 15-Method contains three flexible steps: Identification of clinical problem related to alcohol; feedback and clinical work-up as needed; treatment. Treatment includes structured consultations (maximum of four) with patient home-work assignments, and can be combined with pharmacological treatment for alcohol problems.

Primary outcomes

  1. Proportion of patients exceeding the Danish national low-risk alcohol consumption limits

    Time frame: Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).

    Using Timeline Follow Back one-week data from patient surveys. The Danish national low-risk alcohol consumption limit is maximum 10 standard units (1 unit = 12 grams of ethanol) per week and maximum 4 standard units on a single day. Patients are coded 1 (drinking above limits) or 0 (not drinking above limits).

  2. Number of heavy drinking days per week in patients

    Time frame: Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).

    The number of heavy drinking days (HDD) per week is derived from the Timeline Follow Back one-week (range 0-7 HDD/week) in patient surveys. A HDD is defined as >4 standard units (1 unit = 12 grams of ethanol) on the same day. Is a sum of the number of days patients drink >4 standard units.

Secondary outcomes

  1. Likelihood of alcohol use being addressed during a consultation in general practice

    Time frame: Data is collected from enrollment in trial until the end of the trail (January 2023-August 2024).

    The likelihood of consultations in which the topic of alcohol has been addressed. Alcohol related consultations are continuously registered in the patient filing system throughout the trial period. An alcohol related consultation is defined as a consultation registered with the ICD-10 code z006 and ICPC-2 code A97.

  2. Frequency of use of biomarkers as a screening tool for harmful alcohol use

    Time frame: Data is collected 1 year prior to trial start/enrollment (January 2022-December 2023) and from enrollment in trial until the end of the trial (January 2023-August 2024).

    The frequency of use in general practice. Biomarkers as a screening tool for harmful alcohol use comprise Gamma-Glutamyltransferase (GGT) and Alanine-Aminotransferase (ALAT). Data is obtained from Danish registers. The use of biomarkers as screening tool in the practices will be analyzed, comparing baseline levels to active (post-implementation) levels.

  3. Prescription rate of pharmacological treatment for alcohol problems

    Time frame: Data is collected 1 year prior to trial start/enrollment (January 2022-December 2023) and from enrollment in trial until the end of the trial (January 2023-August 2024).

    The prescription rate in general practice. Pharmacological treatment for alcohol problems comprise Disulfiram, Naltrexone, Acamprosate, and Nalmefene. Data is obtained from Danish registers. The prescription rate in the practices will be analyzed, comparing baseline levels to active (post-implementation) levels.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

iTAPP Study - Identification and Treatment of Alcohol Problems in Primary Care

Acronym: iTAPP

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 23, 2023
Registry last updated
Apr 29, 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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