Cannabis extract treatment for cocaine addiction
"Randomized Double-blind Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of the Use of Cannabis Sativa Extract in the Treatment of Cocaine and Crack Addicts."
PHASE4 · University of Sao Paulo General Hospital · NCT06159387
This study is testing if a cannabis extract can help people struggling with cocaine addiction feel better and reduce their drug use while also receiving therapy.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital (other) |
| Locations | 1 site (São Paulo, Sao Paulo) |
| Trial ID | NCT06159387 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a Cannabis sativa extract containing CBD and low levels of THC in treating cocaine dependence. A total of 60 participants will be randomly assigned to receive either the cannabis extract or a placebo, with both groups also receiving psychotherapy. The study aims to compare the frequency of cocaine use, treatment adherence, and the prevalence of depressive and anxious symptoms between the two groups, while also monitoring side effects. The trial is conducted at the Interdisciplinary Group for Alcohol and Drug Studies at the University of São Paulo.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who meet the DSM-5 criteria for cocaine use disorder.
Not a fit: Patients with schizophrenia, bipolar disorder, or those with a history of severe head trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel pharmacotherapy option for individuals struggling with cocaine addiction.
How similar studies have performed: While the use of cannabis extracts for addiction treatment is an emerging field, this specific approach has not been widely tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, Sao Paulo
- Instituto Perdizes — São Paulo, Sao Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Andre Malbergier, MD, MPH, PhD — Department of Psychiatry - University of São Paulo
- Study coordinator: Andre Malbergier, MD, MPH, PhD
- Email: andre.malbergier@hc.fm.usp.br
- Phone: +5511984183278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cocaine Dependence, Crack/cocaine, Clinical trial, Cannabis extract, Pharmacotherapy