Study to Test the Safety and Efficacy of Cannabidiol as a Treatment Intervention for Opioid Relapse
Condition: Opiate Addiction
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

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 over million
      opiate-dependent subjects today, only less than a quarter of such individuals receive
      treatment. Pharmacotherapeutic approaches traditionally have targeted 5 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 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 exploratory phase of the project to (1) determine the
      safety and basic pharmacokinetic characteristics of CBD when administered concomitantly with
      opiate in humans and (2) characterize the acute (24 hr) and short-term (3 days) effects of
      CBD administration on cue-induced craving in drug-abstinent heroin-dependent subjects using a
      random double blind design. This exploratory investigation together with ongoing
      complementary preclinical rodent studies has the potential to significantly impact the
      development of a novel agent for drug relapse prevention that is critical for ending the
      continued cycle of substance abuse. PUBLIC HEALTH RELEVANCE: 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.
    

Intervention name(s): Cannabidiol; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Subjects in Arm CBD 400 mg will receive 400 mg of Cannabidiol in two test sessions along with 0.5 mcg/kg and 1mcg/kg of fentanyl.
Subjects in Arm CBD 800 mg will receive 800 mg of Cannabidiol in two test sessions along with 0.5 mcg/kg and 1mcg/kg of fentanyl.; All subjects will receive 0.5 mcg/kg and 1mcg/kg of Fentanyl (test session 1 and test session 2)
Other intervention name(s): Fentanyl Citrate
Intervention MeSH terms: Fentanyl; Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment