ClinConnect ClinConnect Logo
Search / Trial NCT06159387

Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Nov 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Crack/Cocaine Clinical Trial Cannabis Extract Pharmacotherapy

ClinConnect Summary

This clinical trial is looking at whether a cannabis extract, which contains a compound called CBD and a small amount of THC, can help people who are struggling with cocaine addiction. Researchers want to find out if this cannabis extract can reduce how much and how often participants use cocaine compared to a placebo, which is a substance that has no active ingredients. They will also check if the cannabis extract affects feelings of anxiety and depression, and if there are any side effects from using it.

To participate in this trial, individuals must be over 18 years old and meet certain criteria for cocaine use disorder. However, people with conditions like schizophrenia or bipolar disorder, those who have recently used marijuana, or those dependent on other substances besides cocaine and tobacco are not eligible. Participants can expect to be divided into two groups, one receiving the cannabis extract and the other receiving the placebo, and will be monitored throughout the study for changes in their cocaine use and overall well-being. This trial is currently recruiting participants of all genders between the ages of 18 and 74.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients over 18 years old Patients who meet the DSM-5 criteria for Cocaine use disorder.
  • Exclusion Criteria:
  • Patients diagnosed with Schizophrenia and Bipolar Affective Disorder Patients with a history of severe head trauma Patients who used marijuana in the last month Patients who meet the criteria for other substances dependence besides crack/cocaine and tobacco.

About University Of Sao Paulo General Hospital

The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.

Locations

São Paulo, Sao Paulo, Brazil

Patients applied

0 patients applied

Trial Officials

Andre Malbergier, MD, MPH, PhD

Principal Investigator

Department of Psychiatry - University of São Paulo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported