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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Treatment as usual
  Participants receiving TAU are not trained to avoid drug-related images and approach positive images.

Первичные конечные точки

• Abstinence days from cocaine after 4 Approach Bias Modification (ABM) training sessions [Срок оценки: 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.]

Вторичные конечные точки (5)

• Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU. [Срок оценки: at 1 and 3 months after the end of training.]
• Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU [Срок оценки: at 1 and 3 months after the end of training]
• Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU. [Срок оценки: at 1 and 3 months after the end of training]
• Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU. [Срок оценки: at 1 month after the end of training]
• Operationalisation of continuous abstinence in participants trained with ABM, relative to TAU. [Срок оценки: at 1 month after the end of training]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Struttura Semplice Servizio Dipendenze — Milan

Идентификаторы

NCT: NCT07033416 · ABMCocaine

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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