Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans

Hurd,Yasmin, Ph.D.

Status and phase: Completed; Phase 2

Conditions: Opiate Addiction

Treatments: Drug: Cannabidiol 400; Drug: Control; Drug: Cannabidiol 800

Study type: Interventional

Identifiers

NCT01605539

R21 DA027781(2)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be between 21 and 65 years old
• Must have an opiate dependence that meets criteria set in the Structured Clinical Interview for DSM-IV(SCID-IV) over the last three months
• No opioid use in the past 7 days (will be verified via urine drug screen and opiate metabolite test)

Exclusion criteria

• Using any psychoactive drug (other than nicotine) any time up to test session 3
• Having a diagnosis of drug dependence (except for heroin or nicotine) in the past 3 months, based on the SCID-IV interview criteria
• Being maintained on methadone or buprenorphine, or taking opioid antagonists such as naltrexone
• Having a positive a drug screen
• Showing signs of acute heroin withdrawal symptoms
• Having medical conditions, including Axis I psychiatric conditions under DSM-IV (examined using the Mini International Neuropsychiatric Interview [MINI])
• Having a a history of cardiac disease, arrhythmias, head trauma, and seizures
• Having a history of hypersensitivity to cannabinoids
• 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
• Participating in a another pharmacotherapeutic trial in the past 3 months
• Being pregnant of breastfeeding
• Not using or irregularly using appropriate methods of contraception such as hormonal contraceptives (e.g., Depo-Provera, Nuva-Ring), an intrauterine device (IUD), or double barrier method (combination of any two barrier methods used simultaneously, e.g., condoms, spermicide, diaphragms)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties.

Treatment:

Drug: Control

Cannabidiol 400

Experimental group

Description:

Subjects in Arm Cannabidiol 400 will receive 400 mg of cannabidiol

Treatment:

Drug: Cannabidiol 400

Cannabidiol 800

Experimental group

Description:

Subjects in Arm Cannabidiol 800 will receive 800mg of cannabidiol

Treatment:

Drug: Cannabidiol 800