Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts

NCT06159387 | Unknown Phase 4 DMC

• 1 other identifier: 69721222.0.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cocaine Dependence

Keywords

Crack/cocaine; Clinical trial; Cannabis extract; Pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  biweekly

Secondary Outcomes (1)

• Safety of the extract of cannabis in patients with crack/cocaine use disorders admitted to treatment

  biweekly

Study Arms (2)

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.

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.

Drug: Cannabis Extract Oil SR Capsule

Interventions

Cannabis Extract Oil SR Capsule DRUG

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

Cannabis extract; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old Patients who meet the DSM-5 criteria for Cocaine use disorder.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto Perdizes

São Paulo, São Paulo, 05021-001,, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 35032495 BACKGROUND

• 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.

  PMID: 34157334 BACKGROUND

• 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.

  PMID: 33464660 BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Andre Malbergier, MD, MPH, PhD

  Department of Psychiatry - University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre Malbergier, MD, MPH, PhD

CONTACT

+5511984183278; andre.malbergier@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, PhD, Head of Alcohol and Drugs Service

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: October 23, 2023
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2025
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: October 2024 to october 2025
• Access Criteria: Researchers in the field

Locations

BR (1)