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