Training for Cocaine Use DisorderABMCocaineNCT07033416
A Trial Of Approach Bias Modification Training During Treatment For Cocaine Use Disorder
A study testing Approach Bias Modification and Treatment as usual in people with Training for Cocaine Use Disorder, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Training for Cocaine Use Disorder
- What is being tested?
- Approach Bias Modification and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Struttura Semplice Servizio Dipendenze
Milan, Milano, 20131
Doriana Losasso, doriana.losasso@asst-fbf-sacco.it
About this study
Official title: A Pilot Randomised Controlled Trial of Approach Bias Modification During Traetment for Cocaine Use Disorder
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.
Read more
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.
- Conditions
- Training for Cocaine Use Disorder
- Being tested
- Approach Bias Modification, Treatment as usual
- Keywords
- APPROACH BIAS MODIFICATION, RCT, COCAINE USE DISORDER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approach Bias ModificationBehavioural
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.
Treatment as usualBehavioural
Participants receiving TAU are not trained to avoid drug-related images and approach positive images.
| Study group | Role | What they receive |
|---|---|---|
| ABM+TAU | Experimental | Participants treated with the experimental training Approach Bias Modification (ABM), and the usual treatment (Treatment As Usual, TAU). Receives: Behavioral: Approach Bias Modification; Behavioral: Treatment as usual |
| TAU | Active comparator | Participants treated with the usual treatment (Treatment As Usual, TAU). Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: at 1 month after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start31 Mar 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Training for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Principal investigator, Doriana Losasso, Psych, ASST Fatebenefratelli Sacco
- Investigators
- Doriana Losasso, Principal investigator, ASST Fatebenefratelli Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033416
- Sponsor's protocol ID
- ABMCocaine
- Acronym
- ABMCocaine
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At present ethics has not approved the sharing of IPD with researchers outside of the investigator team
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Controlled Trial of Approach Bias Modification During Traetment for Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT07033416
- Acronym / sponsor ID
- ABMCocaine / ABMCocaine
- Conditions
- Training for Cocaine Use Disorder
- Keywords
- APPROACH BIAS MODIFICATION, RCT, COCAINE USE DISORDER
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABM+TAU | Experimental | Behavioral: Approach Bias Modification, Behavioral: Treatment as usualParticipants treated with the experimental training Approach Bias Modification (ABM), and the usual treatment (Treatment As Usual, TAU). |
| TAU | Active comparator | Behavioral: Treatment as usualParticipants treated with the usual treatment (Treatment As Usual, TAU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Approach Bias ModificationABM 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. | Behavioural | ABM+TAU |
| Treatment as usualParticipants receiving TAU are not trained to avoid drug-related images and approach positive images. | Behavioural | ABM+TAU, TAU |
Primary outcome
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. At present ethics has not approved the sharing of IPD with researchers outside of the investigator team
Related trials for Training for Cocaine Use Disorder
RecruitingPhase 2
Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction
Cocaine Use Disorder, Cocaine Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doriana Losasso principal investigator
ASST Fatebenefratelli Sacco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Approach Bias Modification and Treatment as usual in people with Training for Cocaine Use Disorder, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefania Cheli, PhD (+390250319643, stefania.cheli@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.