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

ASST Fatebenefratelli Sacco

Status: Enrolling

Conditions: Training for Cocaine Use Disorder

Treatments: Behavioral: Treatment as usual; Behavioral: Approach Bias Modification

Study type: Interventional

Funder types: Other

Identifiers

NCT07033416

ABMCocaine

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

ABM+TAU

Experimental group

Description:

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

Treatment:

Behavioral: Approach Bias Modification

Behavioral: Treatment as usual

TAU

Active Comparator group

Description:

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

Treatment:

Behavioral: Treatment as usual