Cannabidiol and Cocaine Craving/Dependence
Condition: Substance Use Disorder; Cocaine Dependence; Withdrawal From Addictive Substance; Detoxification
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Cannabidiol
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): CBD
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment