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| Name | Class |
|---|---|
| Monash University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABM+TAU | Experimental | Participants treated with the experimental training Approach Bias Modification (ABM), and the usual treatment (Treatment As Usual, TAU). |
|
| TAU | Active Comparator | Participants treated with the usual treatment (Treatment As Usual, TAU). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Approach Bias Modification | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from participating if they have:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefania Cheli, PhD | Contact | +390250319643 | stefania.cheli@asst-fbf-sacco.it |
| Name | Affiliation | Role |
|---|---|---|
| Doriana Losasso | ASST Fatebenefratelli Sacco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Struttura Semplice Servizio Dipendenze | Recruiting | Milan | Milano | 20131 | Italy |
At present ethics has not approved the sharing of IPD with researchers outside of the investigator team
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual | Behavioral | Participants receiving TAU are not trained to avoid drug-related images and approach positive images. |
|
| at 1 and 3 months after the end of training. |
| 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. | at 1 and 3 months after the end of training |
| 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 | at 1 and 3 months after the end of training |
| 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. | at 1 month after the end of training |
| 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 Go/No-go Task for Addiction (MGNT): a measure of suppression of pre-potent responses and control of attention bias for salient stimuli associated with addiction-related. | at 1 month after the end of training |