This trial is active, not recruiting.

Condition opiate addiction
Treatments cannabidiol, placebo
Phase phase 2
Sponsor Hurd,Yasmin, Ph.D.
Start date May 2012
End date October 2013
Trial size 10 participants
Trial identifier NCT01605539, R21 DA027781(2)


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties.
Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study
Subjects will receive 400mg of cannabidiol
Subjects in Arm CBD 400 will receive 400mg of Cannabidiol in each of the three test sessions
Subjects will receive 800mg of cannabidiol
Subjects in Arm CBD 800 will receive 800mg of Cannabidiol in each of the three test sessions

Primary Outcomes

In-Clinic Craving Assessment - The Visual Analog Scale for Craving (VASC)
time frame: 0 min, 25min, 45min, 65min where 0 is the beginning of cue-induced craving session in visits 2, 3, and 5
Out-Clinic Craving Assessment - Heroin Craving Questionnaire
time frame: 4 times in-clinic, pre-dose/craving session and 3 times at home: on average 6-8hrs after end of visits 2, 3, and 4

Secondary Outcomes

Vital Signs
time frame: 23 time points over the course of 5 visits in 2 weeks: pre-dose, (-60min, -40min, -20min), 0min, 25min, {30min} 45min, 65min, [90min] on visits 2, 3, 4, and 5 (where 0 minutes is the onset of cue-inducing session)
CBD Effects on Cognitive Behavior
time frame: 1 time, 30-35 minutes into fourth visit
Diagnostic Measure - EKG
time frame: 25min (pre-screening visit only)
Visual Analog Scale for Anxiety (VASA)
time frame: 5 time points: pre-dose [on visits 2 and visit 4], -20min [visit 3], 0min, 20min, 40min, 65 min (where 0 minutes is the onset of cue-induced craving session)
The Positive and Negative Affect Schedule(PANAS)
time frame: 4 times during visit 2, visit 3, and visit 5: 0min, 25, min, 45min, 65min (where 0 is the onset of the cue-induced craving session)
Physiological Response to Stress - Salivary Cortisol Measures
time frame: 4 times per visit at 0min, 25min, 45min, and 65min (where 0 is the beginning of the video cue session) during visits 2, 3, and 5.
Adverse Effects - SAFTEE
time frame: 3 times: 135min (at the end of visit 2), 100min (at the end of visit 3), and 55min (at the end of visit 4)

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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)

Additional Information

Official title Cannabidiol as Treatment Intervention for Opioid Relapse
Principal investigator Yasmin Hurd, Ph.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Hurd,Yasmin, Ph.D..