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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Training for Cocaine Use Disorder
• Intervention / Treatment: Behavioral: Approach Bias Modification; Behavioral: Treatment as usual

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefania Cheli, PhD; Phone Number: +390250319643; Email: stefania.cheli@asst-fbf-sacco.it

Study Locations

• Italy
  • Milano
    • Milan, Milano, Italy, 20131
      • Recruiting
      • Struttura Semplice Servizio Dipendenze
      • Contact: Doriana Losasso; Email: doriana.losasso@asst-fbf-sacco.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABM+TAU; Participants treated with the experimental training Approach Bias Modification (ABM), and the usual treatment (Treatment As Usual, TAU).	Behavioral: 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.; Behavioral: Treatment as usual; Participants receiving TAU are not trained to avoid drug-related images and approach positive images.
Active Comparator: TAU; Participants treated with the usual treatment (Treatment As Usual, TAU).	Behavioral: Treatment as usual; Participants receiving TAU are not trained to avoid drug-related images and approach positive images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence days from cocaine after 4 Approach Bias Modification (ABM) training sessions	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU.	Operationalisation of continuous abstinence is assessed by urine analysis and self-report questionnaires: • Craving Experience Questionnaire (CEQ): two 10-item scales, one measuring the frequency of cravings over a defined time period, and the other assessing the strength of the strongest cravings during this period.	at 1 and 3 months after the end of training.
Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU	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.	at 1 and 3 months after the end of training
Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU.	Operationalisation of continuous abstinence is assessed by urine analysis and self-report questionnaires: Timeline Follow-back (TLFB): a measure of frequency and quantity of cocaine use and route of administration	at 1 and 3 months after the end of training
Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU.	Operationalisation of continuous abstinence is assessed by urine analysis and self-report questionnaires: Modified Stroop Task for Addiction (MST): a 0-to-100 scale measuring attention regulation and suppression of interference due to semantic incongruence or salience of addiction-related stimuli.	at 1 month after the end of training
Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU.	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.	at 1 month after the end of training

Collaborators and Investigators

• Sponsor: ASST Fatebenefratelli Sacco
• Collaborators: Monash University
• Investigators: Principal Investigator: Doriana Losasso, Asst Fatebenefratelli Sacco

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: June 5, 2025
• First Submitted That Met QC Criteria: June 13, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: RCT; APPROACH BIAS MODIFICATION; COCAINE USE DISORDER
• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: ABMCocaine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At present ethics has not approved the sharing of IPD with researchers outside of the investigator team

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No