Cocaine DependencePhase 4NCT06159387
Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts
A Phase 4 study testing Cannabis Extract Oil SR Capsule in people with Cocaine Dependence, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Cannabis Extract Oil SR Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Oct 2023to 23 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old Patients who meet the DSM-5 criteria for Cocaine use disorder.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Perdizes
São Paulo, São Paulo, 05021-001,
Andre Malbergier, +5511984183278, andre.malbergier@hc.fm.usp.br
About this study
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."
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.
Read the 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
- Conditions
- Cocaine Dependence
- Being tested
- Cannabis Extract Oil SR Capsule
- Keywords
- Crack/cocaine, Clinical trial, Cannabis extract, Pharmacotherapy
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis Extract Oil SR CapsuleDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Cannabis extract | Experimental | 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. Receives: Drug: Cannabis Extract Oil SR Capsule |
| Placebo | Placebo comparator | 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. Receives: Drug: Cannabis Extract Oil SR Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: biweekly
Secondary outcomes (1)
Safety of the extract of cannabis in patients with crack/cocaine use disorders admitted to treatment
Side effects are measured by UKU scale
Measured: biweekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start23 Oct 2023
- Primary completion23 Oct 2024 (estimated)
- Study completion23 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After admission, 60 patients are randomly allocated into 2 groups. A simple randomization are carried out in which the computer program generates a number (0 or 1) for each subject who enters the research. Zero is the the placebo group and 1 is the active drug group. Neither the evaluators nor the patients know which medication each research subject is taking. The laboratory provides identical solutions of active drug and placebo to ensure blinding of the research and only professionals in that laboratory know which is placebo or active drug.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Malbergier, University of Sao Paulo General Hospital
- Investigators
- Andre Malbergier, MD, MPH, PhD, Principal investigator, Department of Psychiatry - University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159387
- Sponsor's protocol ID
- 69721222.0.0000.0068
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
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.
PubMed 35032495Ledesma 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.
PubMed 34157334Mongeau-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.
PubMed 33464660
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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."
- ClinicalTrials.gov ID
- NCT06159387
- Acronym / sponsor ID
- 69721222.0.0000.0068
- Conditions
- Cocaine Dependence
- Keywords
- Crack/cocaine, Clinical trial, Cannabis extract, Pharmacotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Oct 2024 (estimated)
- Study completion
- 23 Oct 2025 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- After admission, 60 patients are randomly allocated into 2 groups. A simple randomization are carried out in which the computer program generates a number (0 or 1) for each subject who enters the research. Zero is the the placebo group and 1 is the active drug group. Neither the evaluators nor the patients know which medication each research subject is taking. The laboratory provides identical solutions of active drug and placebo to ensure blinding of the research and only professionals in that laboratory know which is placebo or active drug.
| Arm | Type | Receives |
|---|---|---|
| Cannabis extract | Experimental | Drug: Cannabis Extract Oil SR CapsuleThirty 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. |
| Placebo | Placebo comparator | Drug: Cannabis Extract Oil SR CapsuleThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old Patients who meet the DSM-5 criteria for Cocaine use disorder.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis Extract Oil SR CapsuleAfter 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 | Drug | Cannabis extract, Placebo |
Primary outcome
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
1 secondary outcome
Safety of the extract of cannabis in patients with crack/cocaine use disorders admitted to treatment
Time frame: biweekly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Background: PubMed 35032495Karimi-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.
- Background: PubMed 34157334Ledesma 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.
- Background: PubMed 33464660Mongeau-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.
- Individual participant dataSharing planned: Yes. all collected IPD
Related trials for Cocaine Dependence
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
Active, not recruitingPhase 1
AAV8-hCocH for Cocaine Use Disorder
Cocaine Dependence, in Remission
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Malbergier, MD, MPH, PhD principal investigator
Department of Psychiatry - University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cannabis Extract Oil SR Capsule in people with Cocaine Dependence, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andre Malbergier, MD, MPH, PhD (+5511984183278, andre.malbergier@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the extract of cannabis compared to placebo (time frame: biweekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159387, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.