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

December 6, 2023 updated by: André Malbergier, University of Sao Paulo General Hospital

"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."

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The project is being developed at the Interdisciplinary Group for Alcohol and Drug Studies (GREA). GREA is a service of the Perdizes Institute - Department of Psychiatry of the Hospital das Clínicas of Medical School of the University of São Paulo that offers specialized treatment for addiction..

After admission, 60 crack/cocaine dependent patients are randomly allocated into 2 groups.

Neither the evaluators nor the patients know which medication each research subject is taking. The laboratory provides the medication and placebo in identical solutions to ensure blinding of the research.

Thirty patients receive (total daily dose) 384 mg of CBD and 11.4 mg of THC divided into one intake in the morning (1 mL of oily solution - 192 mg of CBD and 5.7 mg of THC) and one intake in the evening ( 1 mL of oily solution - 192 mg of CBD and 5.7 mg of THC) during breakfast and dinner and psychotherapy. The other 30 subjects receive placebo (same volumes of oily solution without active ingredient) and psychotherapy.

Titration will be done with an initial dose of 1 mL taken at night and increased over 2 days to 1 mL morning and night. Patients using placebo make similar increments to maintain the blind nature of the study.

Pharmacological treatments for other psychiatric disorders or clinical pathologies are maintained.

Psychotherapeutic treatment consists of weekly group cognitive behavioral therapy for 12 weeks for all patients and under the coordination of a psychologist trained in the field. Each session have a discussion topic. The groups have a maximum of 10 patients and, as this number is reached, a new group is started.

At admission, patients are assessed by the following questionnaires:

Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID5), Addiction Severity Index 6 (ASI 6), Patient Health Questionnaire-9 (PHQ-9), GAD-7 (General Anxiety Disorder-7), Timeline followback (TLFB), Minnesota Cocaine Craving Scale (MCCS).

Also at admission, patients are evaluated by the following blood tests:

Complete blood count, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyltransferase), Alkaline phosphatase, Amylase,Lipase, Fasting blood glucose, Beta-HCG (human chorionic gonadotropin), Total bilirubin and fractions, Urea, Creatinine, Sodium, Potassium, Coagulogram (PT and APTT), Anti-HIV, Ag HBS, Anti HBs, Serology for Syphilis, Serology for Hepatitis C. Those exams will be repeated 2 times throughout the research project.

Patients are assessed biweekly by physicians by the following questionnaires:

TLFB MCCS UKU (Udvalg for Kliniske Undersøgelser) scale for assessing side effects

Urine toxicology tests will be carried out in every physician assessment (biweekly)

Patients are treated for 12 weeks

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05021-001,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cannabis extract
Thirty patients will receive cannabis extract (total daily dose) 384 mg of CBD and 11.4 mg of THC divided into one intake in the morning (1 mL of oily solution - 192 mg of CBD and 5.7 mg of THC) and one intake in the evening ( 1 mL of oily solution - 192 mg of CBD and 5.7 mg of THC) during breakfast and dinner and psychotherapy.
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
Placebo Comparator: Placebo
The other 30 subjects will receive placebo (same volumes of oily solution without active ingredient) and psychotherapy. Titration will be done with an initial dose of 1 mL taken at night and increased over 2 days to 1 mL morning and night. Patients using placebo will make similar increments to maintain the blind nature of the study.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the extract of cannabis compared to placebo
Time Frame: biweekly

The primary outcome will be the comparison of treatment efficacy between the active and placebo groups at weeks 1, 2, 4, 6, 8, 10 and 12. This outcome will be assessed through:

Self-report of improvement by TLFB: The number of days of use and the amount of drugs consumed on those days are registered.

Decrease in crack intensity measured by the MCCS instrument. The MCCS reports the frequency, intensity, and duration of the craving during the last week.

Negative test for cocaine/crack by urine test indicates no use
biweekly

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the extract of cannabis in patients with crack/cocaine use disorders admitted to treatment
Time Frame: biweekly
Side effects are measured by UKU scale
biweekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Andre Malbergier, MD, MPH, PhD, Department of Psychiatry - University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2023

Primary Completion (Estimated)

October 23, 2024

Study Completion (Estimated)

October 23, 2025

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69721222.0.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD

IPD Sharing Time Frame

October 2024 to october 2025

IPD Sharing Access Criteria

Researchers in the field

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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