A Pilot Randomised Controlled Trial of Approach Bias Modification During Traetment for Cocaine Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Abstinence days from cocaine after 4 Approach Bias Modification (ABM) training sessions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Abstinence days from cocaine after 4 Approach Bias Modification (ABM) training sessions
时间窗: 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.
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.
次要结局
- 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 and 3 months after the end of training)
研究者
Doriana Losasso, Psych
Principal Investigator
ASST Fatebenefratelli Sacco