Clinical trial NCT01311778: Study to Test the Safety and Efficacy of Cannabidiol as a Treatment Intervention for Opioid Relapse
Official title: Cannabidiol as Treatment Intervention for Opioid Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opiate Addiction
Lead sponsor: Hurd,Yasmin, Ph.D.
Sponsor class: INDIV
First posted: 2011-03-10
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* being aged between 21 and 65 years old.
* having exposure at least once to an opioid (i.e. codeine, morphine, Fentanyl) in the past

Exclusion Criteria:

* using any psychoactive drug or medication at any time during the study, or 24 hours before the test session
* having a past or current diagnosis of drug abuse or dependence (except for nicotine), based on the SCID-IV interview (Structured Clinical Interview for DSM-IV)
* being maintained on methadone or buprenorphine, or taking opioid antagonist such as naltrexone
* having taken any opioid in the last 14 days
* having medical conditions, including Axis I psychiatric conditions under DSM-IV (examined with the MINI International Neuropsychiatric Interview-MINI), history of cardiac disease, arrhythmias, head trauma, and seizures
* having a history of hypersensitivity to any opioid or cannabinoid
* being pregnant or breastfeeding
* not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. spermicide, diaphragm)
* arriving to the study site visibly intoxicated as determined by a clinical evaluation for signs and symptoms of intoxication and as verified by a drug screen for cocaine, cannabis, opiates, benzodiazepines, barbiturates, phencyclidine and amphetamines
* being actively treated and currently involved in an addiction treatment program
* being an anesthesiologist or a pharmacist

Primary outcomes:
measure: To determine the safety of cannabidiol oral administration prior to fentanyl IV administration.
timeFrame: 9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
Secondary outcomes:
measure: General cannabidiol pharmacokinetics
timeFrame: 9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
measure: Cortisol levels
timeFrame: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
measure: Cannabidiol clearance
timeFrame: 5 timepoints: -60 min, 45, 120, 240, 480
measure: Vital signs-BP
timeFrame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
measure: Vital signs-HR
timeFrame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
measure: Vital signs - RR
timeFrame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
measure: Vital signs - O2
timeFrame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
measure: Vital signs - temp
timeFrame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
measure: Vital signs - EKG
timeFrame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
measure: Subjective measures-VAS
timeFrame: -1, 30, 65, 90, 120, 240, 360, 480 min.
measure: Subjective measures-PANAS
timeFrame: -1, 30, 65, 90, 120, 240, 360, 480 min.
measure: Subjective measures-Opiate effect
timeFrame: -1, 30, 65, 90, 120, 240, 360, 480 min.
measure: Subjective measures- OVAS
timeFrame: -1, 30, 65, 90, 120, 240, 360, 480 min.
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Yasmin Hurd, PhD
role: PRINCIPAL_INVESTIGATOR
References: