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

Not Applicable

Recruiting

• Conditions: Training for Cocaine Use Disorder

• Registration Number: NCT07033416
• Lead Sponsor: ASST Fatebenefratelli Sacco

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Abstinence days from cocaine after 4 Approach Bias Modification (ABM) training sessions	Urine analysis from enrollment to the end of treatment twice a week,in the first three weeks. TLFB at 1 and 3 months after the end of training.	Abstinence days from cocaine measured by urine analysis and a self-report questionnaire (Timeline Follow-Back, TLFB) measuring frequency and quantity of cocaine use and route of administration.

Secondary Outcome Measures

Name	Time	Method
Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU.	at 1 month after the end of training	Operationalisation of continuous abstinence is assessed by urine analysis and self-report questionnaires: Modified Go/No-go Task for Addiction (MGNT): a measure of suppression of pre-potent responses and control of attention bias for salient stimuli associated with addiction-related.
Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU	at 1 and 3 months after the end of training	Severity of Dependence Scale (SDS): a continuous measure of psychological dependence on cocaine. A score of zero is assigned to no cocaine use during the past month.

Trial Locations

Locations (1)

Struttura Semplice Servizio Dipendenze; 🇮🇹 Milano, Italy