Actively Recruiting
Descriptive Study of Observed Behavioural Awareness and Patients Expectations of Treatment
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-15
20
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
I
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying behavioral sensitization (BS), a specific behavioral disturbance seen in people addicted to crack-cocaine. This research focuses on whether BS can be observed in real-life settings among crack users who prefer rapid intake methods like smoking or intravenous use. The study aims to better understand movement changes related to crack use and explore potential biological markers of BS. It also includes a qualitative part to learn about patients' treatment needs and expectations for recovery. Participants will wear an actimeter, a small watch-like device that continuously tracks motor activity day and night for 3 weeks. They will press a button on the device each time they use crack-cocaine to help link behavior with use. During this period, participants will have three blood tests to look for biomarkers such as blood proteins and genetic markers related to BS. The study is observational and does not include medication or placebo treatment. Participants will be involved in wearing the actimeter continuously for three weeks and attending blood test visits. Researchers will assess changes in sleep duration, motor activity patterns, and behavioral scales related to BS. Patient expectations about treatment will be gathered through interviews. Safety is monitored, and the total participation lasts about three weeks, focusing on collecting movement data and biological samples to understand BS better.
CONDITIONS
Brief Title
CRACK-TARGET 1: Descriptive Study of Observed Behavioral Sensitization and Expectations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older
- Have a current crack-cocaine use disorder with severe intensity (6 or more DSM5 criteria) and preferential use of rapid administration route (intravenous or smoked)
- Self-identify as male or female (10 males and 10 females planned)
- Negative pregnancy test for females and use effective contraception
- Be affiliated with a social security plan or equivalent
- Sign informed consent and commit to a 3-week follow-up
- Weigh more than 40 kg
You will not qualify if you...
- Have a psychiatric disorder or symptoms that are not currently stabilized
- Be a minor or under protective supervision (curatorship or guardianship)
- Be in care by judicial authority request (therapeutic injunction or classification with orientation)
- Be pregnant or breastfeeding
- Do not speak French or English sufficiently
- Weigh less than 40 kg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 3 weeks
Participants will wear a small actimeter watch continuously for 3 weeks to monitor motor activity throughout the day and night. They will press a button on the watch each time they use crack-cocaine. Additionally, participants will have 3 blood tests to identify potential biomarkers related to behavioral sensitization.
3 blood test visits and continuous actimeter wear
Trial Site Locations
Total: 2 locations
1
Centre 001_Hôpital Fernand Widal
Paris, France, 75010
Actively Recruiting
2
Hôpital Fernand Widal
Paris, France, F75010
Actively Recruiting
Research Team
F
Florence Vorspan, MD, PhD
F
Florence Vorspan, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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