A Phase 4 interventional study of Cannabis Extract Oil SR Capsule in Cocaine Dependence, sponsored by University of Sao Paulo General Hospital. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by University of Sao Paulo General Hospital · Phase 4, Interventional, and Treatment
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
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
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
Efficacy of the extract of cannabis compared to placebo
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
Time frame: biweekly
Safety of the extract of cannabis in patients with crack/cocaine use disorders admitted to treatment
Side effects are measured by UKU scale
Time frame: biweekly
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Icf
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University of Sao Paulo General Hospital