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Cannabidiol and Cocaine Craving/Dependence (CBD)

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ClinicalTrials.gov Identifier: NCT02559167
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Didier Jutras-Aswad, Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information
First Submitted Date  ICMJE September 22, 2015
First Posted Date  ICMJE September 24, 2015
Last Update Posted Date January 31, 2019
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • 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
  • To assess the 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • 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.
  • To assess cocaine use during the post-detoxification phase [ Time Frame: Day 10 to 92 ]
    The percentage of positive urine tests will be calculated in the usual manner (Castells et al., 2007) i.e., 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).
Current Other Pre-specified Outcome Measures
 (submitted: June 13, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Blood pressure [ Time Frame: Day 1 to 10, Week 4, Week 12 ]
    Blood pressure during the laboratory session and daily during detoxification.
  • Heart rate [ Time Frame: Day 1 to 10, Week 4, Week 12 ]
    Heart rate during the laboratory session and daily during detoxification.
  • 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).
  • Sustained abstinence [ Time Frame: Day 10 to 92 ]
    Defined as three weeks without self-reported cocaine use (using the TLFB) or positive urine test
  • 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.
  • Sleeping pills used during phase 1 (detoxification) [ Time Frame: Day 1 to 10 ]
    Doses of Benadryl or trazodone administered during detoxification.
  • 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.
  • Number of psychosocial intervention sessions (outpatient phase) [ Time Frame: Day 10 to 92 ]
    Number of attended group therapy sessions during the outpatient phase.
  • 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.
  • Completion rate [ Time Frame: Day 10 to 92 ]
    Assessed by determining if participants is still in the study at week 12.
  • 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
  • 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
  • CBD plasma levels [ Time Frame: Day 8, Day 9, Week 4 and Week 12 ]
    CBD plasma levels.
  • 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.
  • 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.
  • Cognition [ Time Frame: Day 1, Day 7, Week 6 ]
    Memory, attention, impulsivity and decision-making will be assessed using a CANTAB battery.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol and Cocaine Craving/Dependence
Official Title  ICMJE Cannabidiol as a New Treatment for Cocaine Addiction
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Substance Use Disorder
  • Cocaine Dependence
  • Withdrawal From Addictive Substance; Detoxification
Intervention  ICMJE 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 Name: CBD
Study Arms  ICMJE
  • 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
    Intervention: Drug: Cannabidiol
  • 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
    Intervention: Drug: Cannabidiol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2015)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amel Zertal, MSc 514-890-8000 ext 36153 amel.zertal.chum@ssss.gouv.qc.ca
Contact: Diego Arizala, MA 514-890-8000 ext 30950 diego.arizala.chum@ssss.gouv.qc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02559167
Other Study ID Numbers  ICMJE 14.183
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Didier Jutras-Aswad, Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor  ICMJE Didier Jutras-Aswad
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Didier Jutras-Aswad, MD,MS,FRCPC Centre de Recherche du CHUM / Université de Montréal
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP