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

NCT ID: NCT01605539

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-10-31

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 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).

Conditions

Opiate Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DRUG

Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study

Cannabidiol 400

Subjects in Arm Cannabidiol 400 will receive 400 mg of cannabidiol

Group Type: EXPERIMENTAL

Cannabidiol 400

Intervention Type: DRUG

Subjects in Arm CBD 400 will receive 400mg of Cannabidiol in each of the three test sessions

Cannabidiol 800

Subjects in Arm Cannabidiol 800 will receive 800mg of cannabidiol

Group Type: EXPERIMENTAL

Cannabidiol 800

Intervention Type: DRUG

Subjects in Arm CBD 800 will receive 800mg of Cannabidiol in each of the three test sessions

Interventions

Cannabidiol 400

Subjects in Arm CBD 400 will receive 400mg of Cannabidiol in each of the three test sessions

Intervention Type: DRUG

Cannabidiol 800

Subjects in Arm CBD 800 will receive 800mg of Cannabidiol in each of the three test sessions

Intervention Type: DRUG

Control

Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study

Intervention Type: DRUG

Other Intervention Names

CBD; CBD; CBD

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hurd,Yasmin, Ph.D.

INDIV

Sponsor Role: lead

Responsible Party

Yasmin Hurd

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasmin Hurd, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

R21DA027781

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21 DA027781(2)

Identifier Type: -

Identifier Source: org_study_id