Cocaine Use DisorderCRACK-TARGETNCT06050304
CRACK-TARGET 1: Descriptive Study of Observed Behavioral Sensitization and Expectations
A study testing Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter and 3 blood tests in people with Cocaine Use Disorder, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
This research focuses on behavioral sensitization (BS) a specific behavioural disturbance in crack-cocaine addiction. The primary objective is to observe whether BS can be demonstrated in an ecological setting in crack dependent users by continuous actimetry for 3 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter and 3 blood tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Mar 2025to 4 Mar 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
- > 18 years
- Have a current crack-cocaine use disorder defined as Severe Intensity Use Disorder (6 or more DSM5 criteria), AND preferential use of rapid administration route (intravenous or smoked)
- Self-identified male or female (n=10 males, n=10 females)
- Negative pregnancy test for females and use of effective contraception
- Be affiliated with a social security plan (or PUMA or CSS or AME)
- Sign an informed consent and commit to a 3-week follow-up in the study
- Have a weight greater than 40 kg
Who cannot join
- • Patient with a psychiatric disorder or symptoms that are not currently stabilized
- Patient who is a minor or under protective supervision (curatorship or guardianship)
- Patient in care at the request of a judicial authority (therapeutic injunction, classification with orientation)
- Pregnant or breastfeeding women
- Patients who do not speak French or English sufficiently
- Patients weighing less than 40 kg
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre 001_Hôpital Fernand Widal
Paris, 75010
- Recruiting
Hôpital Fernand Widal
Paris, F75010
Nora Keltoumi, 33 1 40 05 44 17, Nora.keltoumi@aphp.fr
About this study
Official title: Descriptive Study of Observed Behavioural Awareness and Patients Expectations of Treatment
This research focuses on behavioral sensitization (BS) a specific behavioural disturbance in crack-cocaine addiction. The primary objective is to observe whether BS can be demonstrated in an ecological setting in crack dependent users by continuous actimetry for 3 weeks.
It is planned to include 20 persons with a current crack-cocaine addiction with a preferential use of rapid administration route (intravenous or smoke), in a care institution: Fernand Widal Hospital.
In the proposed research, the investigators will assess the movements of crack-cocaine dependent users in relation to consumption. They will have to wear continuously for 3 weeks an actimeter. They will also have 3 blood tests trying to identify biomarkers of BS.
Read the detailed description
Paris region and the French west indies face a specific epidemic of crack-cocaine use, mostly by socially deprived subjects, highly visible in open drug scenes, with little access to the care system. Patients who suffer from crack-cocaine dependence experiment a high rate of medical and a high mortality rate, because this type of cocaine is a short-acting form, used through rapid route of administration (usually smoked or injected).
Nevertheless, despite important uncovered medical needs, they are not often included in clinical trials and there is to date no pharmacological treatment for this severe condition. The investigators identified behavioral disturbances as a key problem in crack-cocaine dependence, as it is the second cause for emergency visits for those patients and a reason to be excluded from addiction care facilities.
Based on preliminary results already gathered by our group, the investigators suggest that behavioral sensitization (BS), an increase of motor response to cocaine after repetitive intermittent use, could be assessed in Humans.
Our goal is therefore to include 20 persons (10 males - 10 females) with a current cocaine use disorder,specifically crack users, with preferential use of rapid administration route (intravenous or smoke), in a care institution: the Fernand Widal Hospital (Assistance Publique - Hôpitaux de Paris). The investigators will assess the movements of crack-cocaine dependent users in relation to consumption. They will have to wear continuously for 3 weeks an actimeter, in the form of a small watch, which collects the level of motor activity throughout the day and night. They will be asked to indicate each moment of crack-cocaine use by pressing the button in the center of the watch. The investigators want to know if certain uses lead to more behavioral problems (especially after periods of cessation).
They will also have 3 blood tests: the investigators want to know if blood proteins, genetic markers passed on by paricipants parents or the expression of proteins in particular situations, could predict this increase in motor effects for small doses of crack-cocaine.
The investigators also want to better understand the needs of crack-cocaine dependent patients towards treatments and their expectations for recovery, by conducting a qualitative study where patients will participate in the definition of treatment aims to increase the efficiency of care
With the project CRACK-TARGET 1 : DETA, the investigators aim at demonstrating the existence of BS in patients with crack dependent subjects. Furthermore, the investigators aim at developing specific, repeatable, easy to access measure of BS using questionnaires and objective actigraphy biomarkers to be used as surrogate endpoints in clinical trials.
- Conditions
- Cocaine Use Disorder
- Being tested
- Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter, 3 blood tests
- Keywords
- Crack-cocaine, Behavioral Sensitization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeterBehavioural
In the form of a small watch, which collects the level of motor activity throughout the day and night. Patients will be asked to indicate each moment of crack-cocaine use by pressing the button in the center of the watch. We want to know if certain uses lead to more behavioral problems (especially after periods of cessation).
3 blood testsBiological
We will try to identify biomarkers of BS: blood proteins, genetic markers passed on by your parents, or the expression of proteins in particular situations
| Study group | Role | What they receive |
|---|---|---|
| Crack-cocaine Use Disorder users | Experimental | Observation of behaviour in ecological conditions in patients with crack-cocaine dependence Receives: Behavioral: Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter; Biological: 3 blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in sleep duration(hours/minutes) on crack-cocaine use days following a break of at least 2 days compared to crack-cocaine use days without any break (means over the 3 weeks period)
Reduction in sleep duration(hours/minutes) on crack-cocaine use days following a break of at least 2 days compared to crack-cocaine use days without any break (means over the 3 weeks period)
Measured: 3 Weeks
Secondary outcomes (11)
Earlier onset of M10(the time of day when the 10 hours of peak motor activity begins, a reflection of the "motor wake-up time).
The time of day when the 10 hours of peak motor activity begins, a reflection of the "motor wake-up time") (hours/minutes) during crack-cocaine use days following a 2 days break compared to crack-cocaine use days without any break (comparison of mean M10 time)
Measured: 3 Weeks
Shorter relative amplitude of motor activity (the relative difference between M10)
Average activity level during the most active 10-hour period) and L5 (average activity level during the least active 5-hour period) (hours/minutes) during crack-cocaine use days following a 2 days break compared to crack-cocaine use days without any break (comparison of mean relative amplitudes over 3 weeks
Measured: 3 Weeks
Self-defined patients' expectations toward treatment measured in qualitative interviews
Expectations toward treatment measured in qualitative interviews
Measured: 3 Weeks
Higher scores assessed with questionnaires that approximate BS
Higher scores assessed with questionnaires that approximate BS
Measured: 3 weeks
WURS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
WURS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Measured: 3 weeks
ASRS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
ASRS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Measured: 3 weeks
SAPS-CIP in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
SAPS-CIP in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Measured: 3 weeks
YMRS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
YMRS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Measured: 3 weeks
UPPS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
UPPS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Measured: 3 weeks
PDI in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
PDI in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Measured: 3 weeks
PANSS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
PANSS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start4 Mar 2025
- Primary completion4 Mar 2026 (estimated)
- Study completion4 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence VORSPAN, Principal investigator, Hôpital Fernand Widal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050304
- Sponsor's protocol ID
- 2022-A02072-41
- Acronym
- CRACK-TARGET
- Status last verified
- Jun 2025
- First submitted
- 15 May 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be available upon reasonable request made to the promotor (DRCI APHP)
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Observed Behavioural Awareness and Patients Expectations of Treatment
- ClinicalTrials.gov ID
- NCT06050304
- Acronym / sponsor ID
- CRACK-TARGET / 2022-A02072-41
- Conditions
- Cocaine Use Disorder
- Keywords
- Crack-cocaine, Behavioral Sensitization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 4 Mar 2026 (estimated)
- Study completion
- 4 Mar 2026 (estimated)
- First posted
- 22 Sep 2023 (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.
This research focuses on behavioral sensitization (BS) a specific behavioural disturbance in crack-cocaine addiction. The primary objective is to observe whether BS can be demonstrated in an ecological setting in crack dependent users by continuous actimetry for 3 weeks.
It is planned to include 20 persons with a current crack-cocaine addiction with a preferential use of rapid administration route (intravenous or smoke), in a care institution: Fernand Widal Hospital.
In the proposed research, the investigators will assess the movements of crack-cocaine dependent users in relation to consumption. They will have to wear continuously for 3 weeks an actimeter. They will also have 3 blood tests trying to identify biomarkers of BS.
Detailed description
Paris region and the French west indies face a specific epidemic of crack-cocaine use, mostly by socially deprived subjects, highly visible in open drug scenes, with little access to the care system. Patients who suffer from crack-cocaine dependence experiment a high rate of medical and a high mortality rate, because this type of cocaine is a short-acting form, used through rapid route of administration (usually smoked or injected).
Nevertheless, despite important uncovered medical needs, they are not often included in clinical trials and there is to date no pharmacological treatment for this severe condition. The investigators identified behavioral disturbances as a key problem in crack-cocaine dependence, as it is the second cause for emergency visits for those patients and a reason to be excluded from addiction care facilities.
Based on preliminary results already gathered by our group, the investigators suggest that behavioral sensitization (BS), an increase of motor response to cocaine after repetitive intermittent use, could be assessed in Humans.
Our goal is therefore to include 20 persons (10 males - 10 females) with a current cocaine use disorder,specifically crack users, with preferential use of rapid administration route (intravenous or smoke), in a care institution: the Fernand Widal Hospital (Assistance Publique - Hôpitaux de Paris). The investigators will assess the movements of crack-cocaine dependent users in relation to consumption. They will have to wear continuously for 3 weeks an actimeter, in the form of a small watch, which collects the level of motor activity throughout the day and night. They will be asked to indicate each moment of crack-cocaine use by pressing the button in the center of the watch. The investigators want to know if certain uses lead to more behavioral problems (especially after periods of cessation).
They will also have 3 blood tests: the investigators want to know if blood proteins, genetic markers passed on by paricipants parents or the expression of proteins in particular situations, could predict this increase in motor effects for small doses of crack-cocaine.
The investigators also want to better understand the needs of crack-cocaine dependent patients towards treatments and their expectations for recovery, by conducting a qualitative study where patients will participate in the definition of treatment aims to increase the efficiency of care
With the project CRACK-TARGET 1 : DETA, the investigators aim at demonstrating the existence of BS in patients with crack dependent subjects. Furthermore, the investigators aim at developing specific, repeatable, easy to access measure of BS using questionnaires and objective actigraphy biomarkers to be used as surrogate endpoints in clinical trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crack-cocaine Use Disorder users | Experimental | Behavioral: Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter, Biological: 3 blood testsObservation of behaviour in ecological conditions in patients with crack-cocaine dependence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- > 18 years
- Have a current crack-cocaine use disorder defined as Severe Intensity Use Disorder (6 or more DSM5 criteria), AND preferential use of rapid administration route (intravenous or smoked)
- Self-identified male or female (n=10 males, n=10 females)
- Negative pregnancy test for females and use of effective contraception
- Be affiliated with a social security plan (or PUMA or CSS or AME)
Key exclusion criteria (6 listed)
- • Patient with a psychiatric disorder or symptoms that are not currently stabilized
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 |
|---|---|---|
| Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeterIn the form of a small watch, which collects the level of motor activity throughout the day and night. Patients will be asked to indicate each moment of crack-cocaine use by pressing the button in the center of the watch. We want to know if certain uses lead to more behavioral problems (especially after periods of cessation). | Behavioural | Crack-cocaine Use Disorder users |
| 3 blood testsWe will try to identify biomarkers of BS: blood proteins, genetic markers passed on by your parents, or the expression of proteins in particular situations | Biological | Crack-cocaine Use Disorder users |
Primary outcome
Reduction in sleep duration(hours/minutes) on crack-cocaine use days following a break of at least 2 days compared to crack-cocaine use days without any break (means over the 3 weeks period)
Time frame: 3 Weeks
Reduction in sleep duration(hours/minutes) on crack-cocaine use days following a break of at least 2 days compared to crack-cocaine use days without any break (means over the 3 weeks period)
11 secondary outcomes
Earlier onset of M10(the time of day when the 10 hours of peak motor activity begins, a reflection of the "motor wake-up time).
Time frame: 3 Weeks
Shorter relative amplitude of motor activity (the relative difference between M10)
Time frame: 3 Weeks
Self-defined patients' expectations toward treatment measured in qualitative interviews
Time frame: 3 Weeks
Higher scores assessed with questionnaires that approximate BS
Time frame: 3 weeks
WURS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Time frame: 3 weeks
ASRS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Time frame: 3 weeks
SAPS-CIP in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Time frame: 3 weeks
YMRS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Time frame: 3 weeks
UPPS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Time frame: 3 weeks
PDI in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Time frame: 3 weeks
PANSS in patients presenting with at least 1 of the 3 previously defition of BS on actimetric measures compared to patients without BS
Time frame: 3 weeks
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 15 Jan 2026.
- Individual participant dataSharing planned: Yes. IPD can be available upon reasonable request made to the promotor (DRCI APHP)
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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.
Florence VORSPAN principal investigator
Hôpital Fernand Widal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observation of behavior and search of biomarkers with 3 blood tests.3 weeks wearing an actimeter and 3 blood tests in people with Cocaine Use Disorder, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 7 inclusion and 6 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Florence Vorspan, MD, PhD (01 40 05 44 17, Florence.vorspan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in sleep duration(hours/minutes) on crack-cocaine use days following a break of at least 2 days compared to crack-cocaine use days without any break (means over the 3 weeks period) (time frame: 3 Weeks). 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 15 Jan 2026.