Approach Bias Modification training for people with cocaine use disorder

A Pilot Randomised Controlled Trial of Approach Bias Modification During Traetment for Cocaine Use Disorder

This test will try a short computer-based Approach Bias Modification program to see if it reduces cravings and increases days of abstinence in adults with cocaine use disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ASST Fatebenefratelli Sacco (Academic / other)
• Locations: 1 site (Milan, Milano)
• Trial ID: NCT07033416 on ClinicalTrials.gov

What this trial studies

This randomized interventional trial compares a brief computerized Approach Bias Modification (ABM) program plus Treatment As Usual (TAU) against TAU alone in adults with cocaine use disorder. Participants complete one 15-minute ABM session per week for four weeks, using a joystick to push away drug-related images and pull positive images. The primary outcome is the number of days of abstinence after the four ABM sessions, with craving and clinical measures also recorded. The trial is conducted at the ASST Fatebenefratelli Sacco addiction service in Milan, Italy.

Who should consider this trial

Good fit: Adults (18+) with a current DSM-5 TR diagnosis of cocaine use disorder who speak Italian, can provide informed consent, are not on antipsychotic medication, and can attend four weekly sessions are the intended participants.

Not a fit: People with severe psychiatric disorders, significant neurological injury or prolonged loss of consciousness, intellectual disability, current antipsychotic treatment, or inability to attend the in-person sessions are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, ABM could provide a brief, low-cost add-on to usual care that helps people with cocaine use disorder reduce cravings and increase days of abstinence.

How similar studies have performed: ABM has shown mixed but sometimes promising results for alcohol and tobacco use, but it remains relatively untested for cocaine use disorder.

Eligibility criteria

Inclusion Criteria:

* participants must be aged at least 18 years;
* current DSM 5 TR Cocaine Use Disorder;
* sufficient Italian language proficiency to understand the participant information sheet, questionnaires and intervention task instructions;
* signed Consent form.

Exclusion Criteria:

Participants are excluded from participating if they have:

* neurological disorder or injury or brain trauma involving loss of consciousness for longer than 30 minutes;
* severe psychiatric disorder, as evaluated by clinical judgement;
* antipsychotic medication;
* intellectual disability;
* missing Informed Consent;
* planned absence from attendance through the training period (one month).

Where this trial is running

Milan, Milano

• Struttura Semplice Servizio Dipendenze — Milan, Milano, Italy (Recruiting)

Study contacts

• Principal investigator: Doriana Losasso — ASST Fatebenefratelli Sacco
• Study coordinator: Stefania Cheli, PhD

Conditions Training for Cocaine Use Disorder; APPROACH BIAS MODIFICATION; RCT; COCAINE USE DISORDER