Cannabidiol and Cocaine Craving/Dependence (CBD)

October 21, 2020 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Cannabidiol as a New Treatment for Cocaine Addiction

In this study, the investigators seek to evaluate the effects of cannabidiol (CBD) on cocaine craving and relapse. Cocaine addiction is characterized by compulsive substance use and repetitive urges to consume the drug even after a sustained period of abstinence. While substance use remains the most obvious direct outcome of addiction, there is a growing interest in other core symptoms of this disorder. Craving has become a subject of great interest as it is a reliable intermediate phenotype of cocaine relapse and a distressing symptom of addiction associated with suffering. Indeed, even after a period of abstinence, cocaine-dependent individuals remain vulnerable to stress and other craving-inducing stimuli, which, in turn, lead to intense physiological responses and various negative feelings such as anger and sadness. Real-time daily monitoring of craving and drug use has shown that craving predicts cocaine relapse among cocaine-dependent individuals. In sum, working toward improving the treatment of craving could not only help prevent relapse, but also reduce patient distress on emotional, cognitive, and physiological levels. In the past decades, significant scientific efforts have been deployed toward the development of innovative strategies to beat cocaine addiction, but with partial success thus far. Psychosocial approaches have been widely used to help cocaine-dependent patients achieve better outcomes after drug cessation, but literature indicates that these strategies alone are at times insufficient to induce significant behavioural changes or a reduction in rates of drug consumption. Unlike other types of addiction, such as opioid and alcohol, no pharmacological treatment has yet been found to be truly effective in relieving cocaine-cessation symptoms like craving and anxiety or to prevent relapse. CBD is a natural cannabinoid with a favourable tolerability profile and discrete neurobiological actions that are linked to neural circuits closely involved in addiction disorders. Addiction to cocaine is characterized by alternating phases of intoxication and short abstinence, followed by recurrent drug-craving episodes which result in distress and relapse. Our hypothesis is that CBD a cannabinoid known for its broad spectrum properties is an interesting pharmacological contender to decrease cocaine craving and treat cocaine addiction. Previous studies conducted in animals and humans confirm that CBD is a very safe and tolerable medication.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will carry out a double-blind, randomized, parallel-group, placebo-controlled trial to assess the effects of 92 days of CBD 400 mg (for the first 2 days starting on Day 2 of the study) or 800 mg (subjects who report side effects with the 800mg dose will be administered the CBD 400 mg dose for the remainder of the trial) or placebo on cocaine craving and cocaine use among 110 cocaine-dependent individuals. Phase I of the trial will assess the effects of CBD or placebo administration on cocaine craving in the context of a 10-day inpatient medical detoxification period. Phase II of the trial will be a 12-week post-detoxification outpatient follow-up period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre de recherche du Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • DSM-5 criteria for current cocaine use disorder (moderate or severe).
  • Current cocaine use with last use during two weeks prior to admission to the study as confirmed by the Timeline Follow Back questionnaire.
  • Age between 18 and 65 years old (inclusive).
  • Women with diagnosed menopause (as confirmed by the study physician), under the age of 65, will be eligible for the study
  • Subject consents to inpatient detoxification at the CHUM.
  • Ability to give valid, informed consent.
  • Ability to speak and read French or English.

Exclusion criteria

  • Severe and/or unstable hepatic, neurologic (including diagnosis of seizures), cardiac (including arrhythmias) or renal disease), or any other severe or unstable medical condition that precludes safe participation in the study according to the study physician.
  • Patients who are already immunocompromised (e.g., patients with human immunodeficiency virus-1 who do not meet the following criteria: undetectable HIV virus (using modern assay) and CD4 count >350 cells/uL in the last 6 months prior to enrolment, patients on antiretroviral therapy; or other infectious organisms), exhibit malignancy and/or have autoimmune syndromes.
  • Hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
  • Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder); current acute psychosis, mania or severe suicidality based on the Mini International Neuropsychiatric Interview (MINI 7.0)).
  • Pregnancy or breastfeeding.
  • Inability (or unwillingness) of women of childbearing potential to use a medically acceptable form of contraception throughout study duration and for 3 months after dosing stops. A medically acceptable form of contraception is either: (1) contraceptive pill or intrauterine device or depot hormonal preparation (ring, injection, implant); and/or (2) a double barrier method of contraception such as diaphragm, sponge with spermicide and condom.
  • Couples planning to conceive within the next 12 months.
  • Men with history of fertility problems.
  • Another current severe substance use disorder or any substance use disorder that would require pharmacological treatment according to the addiction specialist except nicotine (e.g. benzodiazepine or opiate for alcohol or opioid use disorder).
  • Current treatment with medications that may interact with Cannabidiol (i.e., psychotropic medications such as benzodiazepines or anticonvulsants) or anticipation that the patient may need to initiate such treatment during the study.
  • Any serious medical condition or psychiatric illness that precludes the subject from signing the informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cannabidiol
Participants will receive CBD 800 mg for 92 consecutive days starting on Day 2 of a 10-day inpatient detoxification period followed by 12 weeks of outpatient follow-up
Drug: Cannabidiol
The investigators will carry out a double-blind, randomized, controlled trial comparing the effects of 92 days of 400 (only for the first 2 Days starting on the Day 2 of the study) or 800 mg CBD (subjects who report side effects with the 800mg dose will be administered the CBD 400 mg dose for the remainder of the trial) vs. placebo administration on cocaine craving and relapse in 110 cocaine-dependent subjects.
Other Names:
  • CBD
Placebo Comparator: Placebo
Participants will receive placebo for 92 consecutive days starting on Day 2 of a 10-day inpatient detoxification period followed by 12 weeks of outpatient follow-up
Drug: Cannabidiol
The investigators will carry out a double-blind, randomized, controlled trial comparing the effects of 92 days of 400 (only for the first 2 Days starting on the Day 2 of the study) or 800 mg CBD (subjects who report side effects with the 800mg dose will be administered the CBD 400 mg dose for the remainder of the trial) vs. placebo administration on cocaine craving and relapse in 110 cocaine-dependent subjects.
Other Names:
  • CBD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Drug-cue induced craving
Time Frame: Day 8
A 10-point visual analog scale (VAS) used to measure craving responses in the context of cocaine cue-induced craving during the laboratory session on Day 8 of detoxification
Day 8
Number of days to relapse
Time Frame: Day 10 to 92
The number of days to relapse will be determined as the number of days between detoxification discharge (Day 10) and the day of first cocaine use as determined by the first positive urine test for cocaine (the day prior to urine testing will be entered as the day of relapse) or the first day of cocaine use self-reported by participants (the earliest of both measures)
Day 10 to 92

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stress-induced craving
Time Frame: Day 8
A 10-point VAS used to measure craving responses in the context of stress-induced craving during the laboratory session on Day 8.
Day 8
Cocaine use during the post-detoxification phase
Time Frame: Day 10 to 92
The percentage of positive urine tests will be calculated - we will conservatively assign a 'positive' result to all visits for which the test result is not available for a given subject (including all visits after the subject's loss to follow-up and all scheduled 'intermediate' weekly visits to which the subject did not come or at which the test was not performed).
Day 10 to 92

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Detailed cocaine craving
Time Frame: Day 1, Day 3, Day 5, Day 7, Day 9, Week 1, Week 3, Week 5, Week 7, Week 9, Week11
Assessed using the Cocaine Craving Questionnaire: CCQ-Brief.
Day 1, Day 3, Day 5, Day 7, Day 9, Week 1, Week 3, Week 5, Week 7, Week 9, Week11
Subjective cocaine craving
Time Frame: Day 1, Day 3, Day 5, Day 7, Day 9, Week 1, Week 3, Week 5, Week 7, Week 9, Week11
A 10-point VAS used to measure cocaine craving.
Day 1, Day 3, Day 5, Day 7, Day 9, Week 1, Week 3, Week 5, Week 7, Week 9, Week11
Cocaine withdrawal symptoms
Time Frame: Day 1, Day 3, Day 5, Day 7, Day 9, Week 4, Week 8, Week 12
Assessed using the Cocaine Selective Severity Assessment: CSSA. The CSSA enquires about 18 symptoms commonly reported in the literature as being associated with early cocaine abstinence; items are rated on a scale of 0-7.
Day 1, Day 3, Day 5, Day 7, Day 9, Week 4, Week 8, Week 12
Anxiety
Time Frame: Day 2, Day 9, Week4, and Week 12
Using the Beck Anxiety Inventory (BAI). 21-item self-report scale that measures the severity of anxiety in adults. The BAI total score is the sum of the ratings given by the examinee for the 21 symptoms. Each symptom is rated on a 4-point scale ranging from 0 to 3. The maximum score is 63 points.
Day 2, Day 9, Week4, and Week 12
Subjective anxiety
Time Frame: Day 1, Day 3, Day 5, Day 7, Day 9, Week 1, Week 3, Week 5, Week 7, Week 9, Week11
A 10-point VAS used to measure anxiety.
Day 1, Day 3, Day 5, Day 7, Day 9, Week 1, Week 3, Week 5, Week 7, Week 9, Week11
Positive and negative affect
Time Frame: Day 1, Day 3, Day 5, Day 7, Day 9, Week 1, Week 3, Week 5, Week 7, Week 9, Week11
Positive and Negative Affect Schedule: PANAS is a 10 positive and 10 negative affects rated on a scale from 1 to 5.
Day 1, Day 3, Day 5, Day 7, Day 9, Week 1, Week 3, Week 5, Week 7, Week 9, Week11
Blood pressure
Time Frame: Day 1 to 10, Week 4, Week 12
Blood pressure during the laboratory session and daily during detoxification.
Day 1 to 10, Week 4, Week 12
Heart rate
Time Frame: Day 1 to 10, Week 4, Week 12
Heart rate during the laboratory session and daily during detoxification.
Day 1 to 10, Week 4, Week 12
Self-report cocaine use during the post-detoxification phase
Time Frame: Day 10 to 92
Total number of self-reported days of cocaine use using the Time Line Follow-Back (TLFB).
Day 10 to 92
Sustained abstinence
Time Frame: Day 10 to 92
Defined as three weeks without self-reported cocaine use (using the TLFB) or positive urine test
Day 10 to 92
Addiction severity
Time Frame: Day 2 and Day 92
Using the Addiction Severity Index: ASI-Lite questionnaire. The ASI-Lite is a semi structured interview tool to assess potential problem areas in substance-abusing patients: medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status.
Day 2 and Day 92
Sleeping pills used during phase 1 (detoxification)
Time Frame: Day 1 to 10
Doses of Benadryl or trazodone administered during detoxification.
Day 1 to 10
Depressive symptoms
Time Frame: Day 2, Day 9, Week4 and Week 12
Beck's Depression Inventory second edition: BDI-II. The BDI-II is a 21-item self-report instrument for measuring the severity of depression in adults.
Day 2, Day 9, Week4 and Week 12
Number of psychosocial intervention sessions (outpatient phase)
Time Frame: Day 10 to 92
Number of attended group therapy sessions during the outpatient phase.
Day 10 to 92
Compliance to CBD
Time Frame: Day 10 to 92
Assessed by measuring CBD remaining in bottle weekly during post-detoxification visits and weekly journal entries by patient.
Day 10 to 92
Completion rate
Time Frame: Day 10 to 92
Assessed by determining if participants is still in the study at week 12.
Day 10 to 92
Potential biological substrates of CBD's impact on cocaine craving and relapse - cortisol
Time Frame: Day 2, Day 8 and Week 4
Assessed by measuring cortisol levels
Day 2, Day 8 and Week 4
Potential biological substrates of CBD's impact on cocaine craving and relapse - anandamide
Time Frame: Day 2, Day 8 and Week 4
Assessed by measuring anandamide (AEA) levels
Day 2, Day 8 and Week 4
CBD plasma levels
Time Frame: Day 8, Day 9, Week 4 and Week 12
CBD plasma levels.
Day 8, Day 9, Week 4 and Week 12
Inflammatory markers - leukocytes
Time Frame: Day 2, Day 8, Week 4 and Week 12
Assessed by evaluating modulation of the activation status of the immune cells (circulating leukocytes) in their sera at defined time points.
Day 2, Day 8, Week 4 and Week 12
Inflammatory markers - inflammatory proteins
Time Frame: Day 2, Day 8, Week 4 and Week 12
Assessed by evaluating modulation of the presence of inflammatory proteins in their sera at defined time points.
Day 2, Day 8, Week 4 and Week 12
Cognition
Time Frame: Day 1, Day 7, Week 6
Memory, attention, impulsivity and decision-making will be assessed using a CANTAB battery.
Day 1, Day 7, Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Didier Jutras-Aswad, MD,MS,FRCPC, Centre de Recherche du CHUM / Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14.183

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