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

• Status: Recruiting
• Trial end date: 2025-10-23
• Target enrollment: 0
• Participant gender: All

Summary

2.1. General To evaluate the efficacy and safety of a Cannabis sativa extract (CBD (Cannabidiol) + up to 0.3% THC (Delta-9-tetrahydrocannabinol)), compared to placebo, in the treatment of cocaine/crack use disorder.

2.2. Specifics

• Compare the amount and frequency of cocaine use between the group treated with Cannabis sativa extract and the placebo group

• Compare adherence to treatment between the group treated with Cannabis sativa extract and the placebo group

• Evaluate the prevalence and intensity of depressive and anxious symptoms in patients using Cannabis sativa extract compared to patients using placebo

• Evaluate the incidence and severity of side effects in the active group compared to placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital

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.