Study to Test the Safety and Efficacy of Cannabidiol as a Treatment Intervention for Opioid Relapse
Information source: Hurd,Yasmin, Ph.D.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate Addiction
Intervention: Cannabidiol (Drug); Fentanyl (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Hurd,Yasmin, Ph.D. Official(s) and/or principal investigator(s): Yasmin Hurd, PhD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
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.
Clinical Details
Official title: Cannabidiol as Treatment Intervention for Opioid Relapse
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To determine the safety of cannabidiol oral administration prior to fentanyl IV administration.
Secondary outcome: General cannabidiol pharmacokineticsCortisol levels Cannabidiol clearance Vital signs-BP Vital signs-HR Vital signs - RR Vital signs - O2 Vital signs - temp Vital signs - EKG Subjective measures-VAS Subjective measures-PANAS Subjective measures-Opiate effect Subjective measures- OVAS
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
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Mount Sinai Medical Center, New York, New York 10029, United States
Additional Information
Starting date: February 2010
Last updated: March 20, 2013
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