Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans
Condition: Opiate Addiction
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite the current available therapies for opioid-dependent patients, most patients relapse.
      This research project focuses on the development of a novel compound, cannabidiol, to
      modulate opioid craving in humans based on animal models showing its selective effectiveness
      to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse
      would be of tremendous medical and public health value.
    

Detailed description: 
      There has been an epidemic rise in heroin abuse and overdose in recent years. Of the more
      than one million people suffering today from opiate dependency, less than a quarter of such
      individuals receive treatment. Pharmacotherapeutic approaches traditionally have targeted mu
      opioid receptors since heroin and its metabolites bind with highest affinity to this receptor
      subtype. Although such treatment strategies have improved substance abuse outcomes, they do
      not effectively block opiate craving and thus are still associated with high rates of
      relapse. Using a strategy of indirectly regulating neural systems to modulate opioid-related
      behavior, our preclinical rodent studies consistently demonstrated that cannabidiol (CBD), a
      nonpsychoactive component of cannabis, specifically inhibited cue-induced heroin-seeking
      behavior. CBD's selective effect on drug-seeking behavior was pronounced after 24 hrs and
      endured even two weeks after the last drug administration following short-term CBD exposure.
      The fact that drug craving is generally triggered by exposure to conditioned cues suggests
      that CBD might be an effective treatment for heroin craving, specially given its protracted
      impact on behavior. CBD has already been shown in Phase I of our study and in various
      clinical studies to be well tolerated with a wide safety margin in human subjects. CBD thus
      represents a strong candidate for the development as a potential therapeutic agent in humans
      for opioid craving and relapse prevention. Preliminary pilot study showed CBD decreased
      craving. It is the goal of the current study to more fully characterize the effects of CBD
      administration on cue-induced craving in drug-abstinent heroin-dependent subjects using a
      random double blind design during a post-acute (greater than 6 days since last use) heroin
      withdrawal period. Study participants will be administered CBD during 3 test sessions and
      studied for the effects on cue-induced craving during those sessions as well as one week
      after the final CBD administration on the final test day (session 4).
    

Intervention name(s): CBD 400 mg; CBD 800 mg; Control (placebo)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions; Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions; Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
Other intervention name(s): CBD; CBD; CBD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment