Multimodal Intervention for GGT Reduction in Alcohol Use Disorder (GGT-AUD)

NCT07603726 | Completed DMC

• 1 other identifier: 2/2024
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to evaluate whether a combined nutraceutical and psychological intervention can reduce gamma-glutamyl transferase (GGT) levels in individuals with Alcohol Use Disorder (AUD). The main question it seeks to answer is:

• Does this combined intervention lead to a reduction in GGT levels over time? Participants with Alcohol Use Disorder and elevated GGT levels were included in the study. Participants will:
• Receive nutraceutical supplements aimed at supporting liver function
• Participate in psychological support sessions to help reduce alcohol consumption
• Have their GGT levels monitored over time.

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol Use Disorder; Psychological support; Gamma-glutamyl transferase; Nutraceuticals; Alcohol-related liver disease

Outcome Measures

Primary Outcomes (1)

• Change in serum gamma-glutamyl transferase (GGT) levels

  Assessment of changes in serum GGT levels over time to evaluate the effect of the intervention.

  From baseline through follow-up, assessed up to 12 months

Study Arms (2)

Control Group

OTHER

Alcohol Reduction Counseling

Behavioral: Alcohol Reduction Counseling

Intervention Group

EXPERIMENTAL

Participants with baseline gamma-glutamyl transferase (GGT) levels ≥100 U/L who received a combined intervention consisting of nutraceutical treatment and structured psychological support aimed to reduce alcohol consumption and improve liver-related biomarkers.

Dietary Supplement: Nutraceutical Treatment; Behavioral: Psychological Intervention

Interventions

Alcohol Reduction Counseling BEHAVIORAL

Participants received structured counseling focused on reducing alcohol consumption and improving lifestyle behaviors. The intervention included educational guidance and recommendations regarding alcohol use and general health.

Control Group

Nutraceutical Treatment DIETARY_SUPPLEMENT

Participants received nutraceutical supplementation aimed at supporting liver function and reducing alcohol-related liver stress. The intervention included compounds commonly used for hepatoprotective support.

Intervention Group

Psychological Intervention BEHAVIORAL

Participants received structured psychological support designed to reduce alcohol consumption and improve adherence to behavioral recommendations.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Diagnosis of Alcohol Use Disorder
• Elevated baseline gamma-glutamyl transferase (GGT) levels
• Ability to provide informed consent

You may not qualify if:

• Severe liver disease (e.g., cirrhosis or hepatic failure)
• Severe psychiatric disorders interfering with participation
• Current participation in another clinical study
• Incomplete clinical or laboratory data

Sponsors & Collaborators

• Medical Center TOPMED: lead

Study Sites (1)

Medical Center TOPMED

Târgu Mureş, Mureș County, 540058, Romania

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; Psychosocial Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is an open-label study. No participants, investigators, or outcome assessors were blinded to group assignment.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a non-randomized, parallel-assignment interventional study. Participants were allocated into two groups based on baseline gamma-glutamyl transferase (GGT) levels. Participants with GGT levels between 55-99 U/L were assigned to the control group and received standard guidance only. Participants with GGT levels ≥100 U/L were assigned to the intervention group and received a combined nutraceutical and psychological intervention. Outcomes were assessed over time to evaluate changes in GGT levels.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 22, 2026
• Study Start: January 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)