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The importance of an initial sober month of in the treatment of alcohol dependence with a focus on controlled drinking: short- and long-term effects on alcohol consumption and health status

The importance of an initial month of complete sobriety in the treatment of alcohol use disorder with a focus on controlled drinking: effects on alcohol consumption and health status in short- and long-term follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47033189
Enrollment
200
Registered
2024-11-22
Start date
2023-01-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alocohol use disorder Mental and Behavioural Disorders

Interventions

Cognitive behavioral treatment for the goal of controlled drinking with an add-on of a sober month including optional pharmacological support compared to cognitive behavioral treatment for the goal of

Sponsors

Karolinska Institutet
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Fulfilment of an alcohol use disorder/Alcohol dependence diagnosis, defined as meeting 2 or more criteria for alcohol use disorder according to the DSM-5, or 3 or more criteria according to ICD-10 2. Alcohol consumption exceeding 10 standard drinks (12 grams of pure ethanol) and/or binge drinking exceeding 4/5 standard drinks (women/men) per occasion, one or more times per month in the 30 days before the assessment day 3. A stated treatment goal of controlled drinking 4. Sufficient skills in reading and writing in Swedish

Exclusion criteria

Exclusion criteria: 1. Initiated a sober period/abstinence goal before inclusion 2. A severe psychiatric or somatic comorbidity, e.g., psychosis, bipolar disorder, liver disease with transaminase levels exceeding three times clinical cutoffs, ongoing treatment for a severe cardiovascular disease, and cancer

Design outcomes

Primary

MeasureTime frame
1. Mean weekly alcohol consumption (in standard drinks) is measured using a structured interview following the Timeline Follow-Back (TLFB) method at baseline and 6-month follow-up 2. Frequency of binge drinking (4 or more/5 or more, women/men, standard drinks per drinking occasion) in the previous 30-day period is measured using a structured interview following the Timeline Follow-Back (TLFB) method at baseline and 6-month follow-up

Secondary

MeasureTime frame
1. Alcohol consumption is measured using Phosphatidylethanol (PEth) at one and six months post inclusion 2. Liver function is measured using analyses of Gamma-glutamyltransferase (GGT), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at one and six months post inclusion 3. Goal-setting (abstinence or reduced consumption) is measured using a goal-setting questionnaire at one and six months post inclusion 4. Degree of alcohol dependence is measured using a questionnaire for dependence criteria according to ICD-10 and DSM-5 at one and six months post inclusion 5. Degree of alcohol dependence is measured using the Alcohol Use Disorders Identification Test (AUDIT) at one and six months post inclusion 6. Motivation for change and confidence in the ability to change drinking habits is measured using self-assessment on a Visual Analog Scale (VAS) at one and six months post inclusion 7. Heart rate is measured at one and six months post inclusion 8. Blood pressure is measured using an automatic blood pressure monitor after 10 minutes of rest at one and six months post inclusion 9. Lipids (HDL and LDL cholesterol, and triglycerides) are measured using blood samples at one and six months post inclusion 10. Glucose is measured using blood samples at one and six months post inclusion 11. Level of anxiety is measured using GAD-7 at one and six months post inclusion 12. Level of depression is measured using PHQ-9 at one and six months post inclusion

Countries

Sweden

Contacts

Public ContactSven Andréasson
sven.andreasson@ki.se+46 8-12345780

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026