This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Cannabidiol and Cocaine Craving/Dependence (CBD)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Didier Jutras-Aswad, Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Information provided by (Responsible Party):
Didier Jutras-Aswad, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT02559167
First received: September 22, 2015
Last updated: June 13, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Substance Use Disorder Cocaine Dependence Withdrawal From Addictive Substance; Detoxification Drug: Cannabidiol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Cannabidiol as a New Treatment for Cocaine Addiction

Resource links provided by NLM:


Further study details as provided by Didier Jutras-Aswad, Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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.


Estimated Enrollment: 110
Study Start Date: February 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: CBD

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-5 criteria for cocaine use disorder (moderate or severe).
  • Current cocaine use with last use during the week prior to admission to the study, as confirmed by urine drug screening and the Time-Line Follow-Back questionnaire
  • Women with diagnosed menopause (as confirmed by the study physician), under the age of 65, will be eligible for the study
  • Age between 18 and 65 years old
  • Subject is eligible for and consents to inpatient detoxification at the CHUM
  • Ability to give valid, informed consent
  • Ability to speak and read French or English (grade-nine level of language required)

Exclusion Criteria:

  • Serious medical condition (e.g., severe and/or unstable hepatic, neurologic, cardiac (including arrhythmias) or renal disease).
  • Patients who are already immunocompromised (e.g., patients with human immunodeficiency virus-1 or other infectious organisms), exhibit malignancy and/or have autoimmune syndromes.
  • History of seizures
  • Hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
  • Severe psychiatric condition (e.g., current acute psychosis, severe agitation, mania, major depression, 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 substance dependence (except nicotine) based on the SCID
  • 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
  • Another current severe substance use disorder or any substance use disorder that would require pharmacological treatment according to the addiction specialist (e.g. benzodiazepine or opiate for alcohol or opioid use disorder).
  • Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form
  • Any patient, who in the opinion of the investigator, should not participate in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02559167

Contacts
Contact: Diego Arizala, M.A 514-890-8000 ext 30950 diego.arizala.chum@ssss.gouv.qc.ca
Contact: Amel Zertal, MSc 514-890-8000 ext 36153 amel.zertal.chum@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre de recherche du Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2X 0A9
Contact: Diego Arizala, M.A    514 890-8000 ext 30950    diego.arizala.chum@ssss.gouv.qc.ca   
Contact: Amel Zertal, MSc    514 890-8000 ext 36153    amel.zertal.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Didier Jutras-Aswad
Investigators
Principal Investigator: Didier Jutras-Aswad, MD,MS,FRCPC Centre de Recherche du CHUM / Université de Montréal
  More Information

Responsible Party: Didier Jutras-Aswad, M.D., M.Sc., FRCPC, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02559167     History of Changes
Other Study ID Numbers: 14.183
Study First Received: September 22, 2015
Last Updated: June 13, 2017

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on June 28, 2017