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

NCT06159387 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-13

No results posted yet for this study

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.

Conditions

  • Cocaine Dependence

Interventions

DRUG

Cannabis Extract Oil SR Capsule

After randomization, in a double blind model, subjects receive cannabis extract or placebo conditioned in identical vials with the same volume of substance. Everyone will undergo psychotherapy in the CBT (cognitive behavioral therapy) model

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Andre Malbergier, MD, MPH, PhD · Department of Psychiatry - University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2024-10-23
Completion
2025-10-23

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06159387 on ClinicalTrials.gov