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.
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.
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;
Parallel
Approach Bias Modification
BehavioralABM 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
BehavioralParticipants receiving TAU are not trained to avoid drug-related images and approach positive images.
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.
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.
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.
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
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.
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ASST Fatebenefratelli Sacco
Lead sponsor
Monash University
Collaborator
