Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts
NCT ID: NCT06159387
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2023-10-23
2025-10-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sao Paulo General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
André Malbergier
MD, MPH, PhD, Head of Alcohol and Drugs Service
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andre Malbergier, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry - University of São Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto Perdizes
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Andre Malbergier
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Karimi-Haghighi S, Razavi Y, Iezzi D, Scheyer AF, Manzoni O, Haghparast A. Cannabidiol and substance use disorder: Dream or reality. Neuropharmacology. 2022 Apr 1;207:108948. doi: 10.1016/j.neuropharm.2022.108948. Epub 2022 Jan 13.
Ledesma JC, Manzanedo C, Aguilar MA. Cannabidiol prevents several of the behavioral alterations related to cocaine addiction in mice. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Dec 20;111:110390. doi: 10.1016/j.pnpbp.2021.110390. Epub 2021 Jun 19.
Mongeau-Perusse V, Brissette S, Bruneau J, Conrod P, Dubreucq S, Gazil G, Stip E, Jutras-Aswad D. Cannabidiol as a treatment for craving and relapse in individuals with cocaine use disorder: a randomized placebo-controlled trial. Addiction. 2021 Sep;116(9):2431-2442. doi: 10.1111/add.15417. Epub 2021 Feb 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
69721222.0.0000.0068
Identifier Type: -
Identifier Source: org_study_id