Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-05-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01605539

Opiate Addiction

COMPLETED PHASE2

Cannabidiol and Cocaine Craving/Dependence

NCT02559167

Substance Use Disorder Cocaine Dependence Withdrawal From Addictive Substance; Detoxification

COMPLETED PHASE2

Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts

NCT06159387

Cocaine Dependence

RECRUITING PHASE4

Pharmacotherapy & CM for Opioid and Cocaine Dependence

NCT00838981

Cocaine Dependence

COMPLETED PHASE1/PHASE2

Individualized Neuromodulation of Craving Control for Meth Use Disorders

NCT06695637

Substance Use Disorders Methamphetamine Use Disorders

WITHDRAWN EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There has been an epidemic rise in heroin abuse and overdose in recent years. 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. Preliminary pilot study showed CBD decreased craving. It is the goal of the current study to more fully 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

See the medical conditions and disease areas that this research is targeting or investigating.

Opiate Addiction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties

Group Type PLACEBO_COMPARATOR

Control (placebo)

Intervention Type DRUG

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

CBD 400mg

Subjects will receive 400mg of cannabidiol

Group Type EXPERIMENTAL

CBD 400 mg

Intervention Type DRUG

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

CBD 800mg

Subjects will receive 800 mg of cannabidiol

Group Type EXPERIMENTAL

CBD 800 mg

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBD 400 mg

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

Intervention Type DRUG

CBD 800 mg

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

Intervention Type DRUG

Control (placebo)

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CBD CBD CBD

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Structured Clinical Interview for DSM (SCID-V) 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-V 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-V (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