Clinical trial NCT01605539
Conditions: Opiate Addiction
Sponsor: Hurd,Yasmin, Ph.D.
Start date: 2012-05-01; Completion date: 2013-10-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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).

Arms: arm 1: Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties. arm 2: Subjects in Arm Cannabidiol 400 will receive 400 mg of cannabidiol arm 3: Subjects in Arm Cannabidiol 800 will receive 800mg of cannabidiol
Interventions: intervention 1: Cannabidiol 400 intervention 2: Cannabidiol 800 intervention 3: Control
Intervention descriptions: intervention 1: Subjects in Arm CBD 400 will receive 400mg of Cannabidiol in each of the three test sessions intervention 2: Subjects in Arm CBD 800 will receive 800mg of Cannabidiol in each of the three test sessions intervention 3: Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study

Protocol documents: