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

NCT07033416 | Recruiting

• 1 other identifier: ABMCocaine
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU.

  at 1 and 3 months after the end of training.

• Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU

  at 1 and 3 months after the end of training

• Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU.

  at 1 and 3 months after the end of training

• Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU.

  at 1 month after the end of training

• Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU.

  at 1 month after the end of training

Study Arms (2)

ABM+TAU

EXPERIMENTAL

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

Behavioral: Approach Bias Modification; Behavioral: Treatment as usual

TAU

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual

Interventions

Approach Bias Modification 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.

ABM+TAU

Treatment as usual BEHAVIORAL

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

ABM+TAU; TAU

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead
• Monash University: collaborator

Study Sites (1)

Struttura Semplice Servizio Dipendenze

Milan, Milano, 20131, Italy

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Doriana Losasso

  ASST Fatebenefratelli Sacco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Cheli, PhD

CONTACT

+390250319643; stefania.cheli@asst-fbf-sacco.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 24, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)