NCT02559167

Cannabidiol and Cocaine Craving/Dependence

Cannabidiol as a New Treatment for Cocaine Addiction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Substance Use Disorder
• Cocaine Dependence
• Withdrawal From Addictive Substance; Detoxification

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-08-16
• Completion: 2019-08-16
• First posted: 2015-09-24
• Last updated: 2020-10-23

Locations

1 site across 1 country: Canada