Acute and Short-term Effects of Cannabidiol Admin 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: 
      Opioid abuse is a significant global public health problem. 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. It is the goal of this second exploratory phase of
      the project to 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): Cannabidiol 400; Cannabidiol 800; Control
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects in Arm CBD 400 will receive 400mg of Cannabidiol in each of the three test sessions; Subjects in Arm CBD 800 will receive 800mg of Cannabidiol in each of the three test sessions; Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study
Other intervention name(s): CBD; CBD; CBD
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment