A Trial Of Approach Bias Modification Training During Treatment For Cocaine Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Approach Bias Modification, Treatment as usual.
- Who it may be relevant to
- Registry conditions: Training for Cocaine Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Randomised Controlled Trial of Approach Bias Modification During Traetment for Cocaine Use Disorder
Overview
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.
Interventions
- 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.
Primary outcome measures
- Abstinence days from cocaine after 4 Approach Bias Modification (ABM) training sessions [Time frame: 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 (5)
- Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU. [Time frame: at 1 and 3 months after the end of training.]
- Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU [Time frame: at 1 and 3 months after the end of training]
- Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU. [Time frame: at 1 and 3 months after the end of training]
- Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU. [Time frame: at 1 month after the end of training]
- Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU. [Time frame: at 1 month after the end of training]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Struttura Semplice Servizio Dipendenze — Milan
Identifiers
NCT: NCT07033416 · ABMCocaine