A Trial Of Approach Bias Modification Training During Treatment For Cocaine Use Disorder

NCT ID: NCT07033416

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2026-10-31

Brief Summary

The goal of this clinical trial is to investigate if the intervention "Approach Bias Modification" (ABM) can low cocaine craving in people with Cocaine Use Disorder (CUD).

The main question this clinical trial aims to answer is how many days participants can be in abstinence from cocaine after 4 ABM sessions.

ABM is a computerised training aiming to train the participants to:

• avoid drug-related images by pushing a joystick which causes the image to disappear;
• approach positive images by pulling a joystick which causes the image to expand.

Researchers will compare participants treated with ABM to those who receive Treatment As Usual (TAU) condition to see if ABM training for CUD is more effective in increasing the number of abstinent days.

• Participants will attend 1 ABM session per week for a total of 4 sessions, each lasting 15 minutes.
• Both cocaine and non-cocaine positive images relative to the subjective values or interests (i.e. effects, sport, music, nature, work, etc.) are presented to the participant, in portrait or landscape orientation.
• Participants are instructed to push the joystick if the image is portrait-oriented (cocaine-related images) or to pull the joystick if it is landscape-oriented (positive images).
• At 1 and 3-month-follow up, participants will complete self-report questionnaires to measure abstinence days and describe the effect of ABM on cocaine use, dependence symptoms, and approach bias.

Conditions

Training for Cocaine Use Disorder

Keywords

APPROACH BIAS MODIFICATION; RCT; COCAINE USE DISORDER

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ABM+TAU

Participants treated with the experimental training Approach Bias Modification (ABM), and the usual treatment (Treatment As Usual, TAU).

Group Type: EXPERIMENTAL

Approach Bias Modification

Intervention Type: BEHAVIORAL

ABM is a computerised training aiming to train the participants to avoid drug-related images (by pushing a joystick which causes the image to disappear) and approach positive images (by pulling a joystick which causes the image to expand). Each training session lasts 15 minutes and it takes place once per week for 4 weeks.

Treatment as usual

Intervention Type: BEHAVIORAL

Participants receiving TAU are not trained to avoid drug-related images and approach positive images.

TAU

Participants treated with the usual treatment (Treatment As Usual, TAU).

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

Participants receiving TAU are not trained to avoid drug-related images and approach positive images.

Interventions

Approach Bias Modification

ABM is a computerised training aiming to train the participants to avoid drug-related images (by pushing a joystick which causes the image to disappear) and approach positive images (by pulling a joystick which causes the image to expand). Each training session lasts 15 minutes and it takes place once per week for 4 weeks.

Intervention Type: BEHAVIORAL

Treatment as usual

Participants receiving TAU are not trained to avoid drug-related images and approach positive images.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monash University

OTHER

Sponsor Role: collaborator

ASST Fatebenefratelli Sacco

OTHER

Sponsor Role: lead

Responsible Party

Doriana Losasso, Psych

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doriana Losasso

Role: PRINCIPAL_INVESTIGATOR

ASST Fatebenefratelli Sacco

Locations

Struttura Semplice Servizio Dipendenze

Milan, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefania Cheli, PhD

Role: CONTACT

Phone: +390250319643

Email: stefania.cheli@asst-fbf-sacco.it

Facility Contacts

Doriana Losasso

Role: primary

Other Identifiers

ABMCocaine

Identifier Type: -

Identifier Source: org_study_id