Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159387
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-11-28
Brief Title:
Randomized Double-blind Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
21 General To evaluate the efficacy and safety of a Cannabis sativa extract CBD Cannabidiol up to 03 THC Delta-9-tetrahydrocannabinol compared to placebo in the treatment of cocainecrack use disorder
22 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
22 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:
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 crackcocaine 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 114 mg of THC divided into one intake in the morning 1 mL of oily solution - 192 mg of CBD and 57 mg of THC and one intake in the evening 1 mL of oily solution - 192 mg of CBD and 57 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 AmylaseLipase 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
After admission 60 crackcocaine 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 114 mg of THC divided into one intake in the morning 1 mL of oily solution - 192 mg of CBD and 57 mg of THC and one intake in the evening 1 mL of oily solution - 192 mg of CBD and 57 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 AmylaseLipase 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None