Opiate AddictionPhase 1NCT01311778
Study to Test the Safety and Efficacy of Cannabidiol as a Treatment Intervention for Opioid Relapse
A Phase 1 study testing Cannabidiol and Fentanyl in people with Opiate Addiction, run by Hurd,Yasmin, Ph.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- Cannabidiol and Fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being aged between 21 and 65 years old.
- having exposure at least once to an opioid (i.e. codeine, morphine, Fentanyl) in the past
Who cannot join
- using any psychoactive drug or medication at any time during the study, or 24 hours before the test session
- having a past or current diagnosis of drug abuse or dependence (except for nicotine), based on the SCID-IV interview (Structured Clinical Interview for DSM-IV)
- being maintained on methadone or buprenorphine, or taking opioid antagonist such as naltrexone
- having taken any opioid in the last 14 days
- having medical conditions, including Axis I psychiatric conditions under DSM-IV (examined with the MINI International Neuropsychiatric Interview-MINI), history of cardiac disease, arrhythmias, head trauma, and seizures
- having a history of hypersensitivity to any opioid or cannabinoid
Show all 11Show fewer
- being pregnant or breastfeeding
- not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. spermicide, diaphragm)
- 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 for cocaine, cannabis, opiates, benzodiazepines, barbiturates, phencyclidine and amphetamines
- being actively treated and currently involved in an addiction treatment program
- being an anesthesiologist or a pharmacist
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: Cannabidiol as Treatment Intervention for Opioid Relapse
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.
Read the detailed description
Opioid abuse is a significant global public health problem. Of the over million opiate-dependent subjects today, only less than a quarter of such individuals receive treatment. Pharmacotherapeutic approaches traditionally have targeted 5 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 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 exploratory phase of the project to (1) determine the safety and basic pharmacokinetic characteristics of CBD when administered concomitantly with opiate in humans and (2) characterize the acute (24 hr) and short-term (3 days) effects of CBD administration on cue-induced craving in drug-abstinent heroin-dependent subjects using a random double blind design. This exploratory investigation together with ongoing complementary preclinical rodent studies has the potential to significantly impact the development of a novel agent for drug relapse prevention that is critical for ending the continued cycle of substance abuse. PUBLIC HEALTH RELEVANCE: 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.
- Conditions
- Opiate Addiction
- Being tested
- Cannabidiol, Fentanyl
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Subjects in Arm CBD 400 mg will receive 400 mg of Cannabidiol in two test sessions along with 0.5 mcg/kg and 1mcg/kg of fentanyl.
Subjects in Arm CBD 800 mg will receive 800 mg of Cannabidiol in two test sessions along with 0.5 mcg/kg and 1mcg/kg of fentanyl.
FentanylDrug
Also called Fentanyl Citrate
All subjects will receive 0.5 mcg/kg and 1mcg/kg of Fentanyl (test session 1 and test session 2)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will receive placebo Receives: Drug: Fentanyl |
| CBD 400 mg | Experimental | Subjects will receive 400 mg CBD Receives: Drug: Cannabidiol; Drug: Fentanyl |
| CBD 800mg | Experimental | Subjects will receive 800 mg CBD Receives: Drug: Cannabidiol; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of cannabidiol oral administration prior to fentanyl IV administration.
We will assess safety and adverse effects with the Systematic Assessment for Treatment Emergent Events (SAFTEE). Excessive sedation (GCS<10), cardiac dysrhythmia (on telematry monitor), hypotension (blood pressure < 90/60 mmHg), bradycardia (heart rate 50/minute),severe anxiety, or seizures (partial or generalized tonic-clonic) after the administration of either Fentanyl or Cannabidiol would result in discontinuation of the study for the subject and immediate medical attention.
Measured: 9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
Secondary outcomes (13)
General cannabidiol pharmacokinetics
Blood will be taken at specified times to determine cannabidiol peak plasma concentration (Cmax), time to reach peak serum concentration (tmax) and serum elimination half-life (t1/2).
Measured: 9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
Cortisol levels
Variation in plasma levels of cortisol will be measured at various time points.
Measured: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
Cannabidiol clearance
Urine will be taken at specified times to estimate cannabidiol concentration in order to assess clearance and excretion functions.
Measured: 5 timepoints: -60 min, 45, 120, 240, 480
Vital signs-BP
Blood pressure (mmHg) will be monitored and change from baseline will be studied across the multiple time points.
Measured: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Vital signs-HR
Heart rate (beats/minute) will be monitored and change from baseline will be studied across the multiple time points.
Measured: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Vital signs - RR
respiratory rate (respirations/minute) will be monitored and change from baseline will be studied across the multiple time points.
Measured: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Vital signs - O2
% oxygen saturation will be monitored and change from baseline will be studied across the multiple time points.
Measured: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Vital signs - temp
body temperature (degrees Fahrenheit) will be monitored and change from baseline will be studied across the multiple time points.
Measured: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Vital signs - EKG
EKG will be monitored and change from baseline will be studied across the multiple time points.
Measured: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Subjective measures-VAS
Questionnaires will be used to measure subjective responses. Anxiety will be assessed using a visual analog scale (VAS).
Measured: -1, 30, 65, 90, 120, 240, 360, 480 min.
Subjective measures-PANAS
Questionnaires will be used to measure subjective responses. The PANAS (Positive and Negative Affect Schedule) will allow obtaining positive and negative affect measures.
Measured: -1, 30, 65, 90, 120, 240, 360, 480 min.
Subjective measures-Opiate effect
Questionnaires will be used to measure subjective responses. Global Intoxication and Withdrawal Rating will be administered to assess potential variations in the subjective effects associated to fentanyl.
Measured: -1, 30, 65, 90, 120, 240, 360, 480 min.
Subjective measures- OVAS
Questionnaires will be used to measure subjective responses. Opiate Visual Analog Scales (OVAS) will be administered to assess potential variations in the subjective effects associated to fentanyl.
Measured: -1, 30, 65, 90, 120, 240, 360, 480 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hurd,Yasmin, Ph.D.
- Responsible party
- Principal investigator, Yasmin Hurd, Hurd,Yasmin, Ph.D.
- Investigators
- Yasmin Hurd, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311778
- Sponsor's protocol ID
- R21DA027781
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2011
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol as Treatment Intervention for Opioid Relapse
- ClinicalTrials.gov ID
- NCT01311778
- Acronym / sponsor ID
- R21DA027781
- Conditions
- Opiate Addiction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hurd,Yasmin, Ph.D.
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 over million opiate-dependent subjects today, only less than a quarter of such individuals receive treatment. Pharmacotherapeutic approaches traditionally have targeted 5 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 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 exploratory phase of the project to (1) determine the safety and basic pharmacokinetic characteristics of CBD when administered concomitantly with opiate in humans and (2) characterize the acute (24 hr) and short-term (3 days) effects of CBD administration on cue-induced craving in drug-abstinent heroin-dependent subjects using a random double blind design. This exploratory investigation together with ongoing complementary preclinical rodent studies has the potential to significantly impact the development of a novel agent for drug relapse prevention that is critical for ending the continued cycle of substance abuse. PUBLIC HEALTH RELEVANCE: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: FentanylSubjects will receive placebo |
| CBD 400 mg | Experimental | Drug: Cannabidiol, Drug: FentanylSubjects will receive 400 mg CBD |
| CBD 800mg | Experimental | Drug: Cannabidiol, Drug: FentanylSubjects will receive 800 mg CBD |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being aged between 21 and 65 years old.
- having exposure at least once to an opioid (i.e. codeine, morphine, Fentanyl) in the past
Key exclusion criteria (11 listed)
- using any psychoactive drug or medication at any time during the study, or 24 hours before the test session
- having a past or current diagnosis of drug abuse or dependence (except for nicotine), based on the SCID-IV interview (Structured Clinical Interview for DSM-IV)
- being maintained on methadone or buprenorphine, or taking opioid antagonist such as naltrexone
- having taken any opioid in the last 14 days
- having medical conditions, including Axis I psychiatric conditions under DSM-IV (examined with the MINI International Neuropsychiatric Interview-MINI), history of cardiac disease, arrhythmias, head trauma, and seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolSubjects in Arm CBD 400 mg will receive 400 mg of Cannabidiol in two test sessions along with 0.5 mcg/kg and 1mcg/kg of fentanyl. Subjects in Arm CBD 800 mg will receive 800 mg of Cannabidiol in two test sessions along with 0.5 mcg/kg and 1mcg/kg of fentanyl. | Drug | CBD 400 mg, CBD 800mg |
| FentanylAlso: Fentanyl CitrateAll subjects will receive 0.5 mcg/kg and 1mcg/kg of Fentanyl (test session 1 and test session 2) | Drug | CBD 400 mg, CBD 800mg, Placebo |
Primary outcome
To determine the safety of cannabidiol oral administration prior to fentanyl IV administration.
Time frame: 9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
We will assess safety and adverse effects with the Systematic Assessment for Treatment Emergent Events (SAFTEE). Excessive sedation (GCS<10), cardiac dysrhythmia (on telematry monitor), hypotension (blood pressure < 90/60 mmHg), bradycardia (heart rate 50/minute),severe anxiety, or seizures (partial or generalized tonic-clonic) after the administration of either Fentanyl or Cannabidiol would result in discontinuation of the study for the subject and immediate medical attention.
13 secondary outcomes
General cannabidiol pharmacokinetics
Time frame: 9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
Cortisol levels
Time frame: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
Cannabidiol clearance
Time frame: 5 timepoints: -60 min, 45, 120, 240, 480
Vital signs-BP
Time frame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Vital signs-HR
Time frame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Vital signs - RR
Time frame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Vital signs - O2
Time frame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Vital signs - temp
Time frame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Vital signs - EKG
Time frame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
Subjective measures-VAS
Time frame: -1, 30, 65, 90, 120, 240, 360, 480 min.
Subjective measures-PANAS
Time frame: -1, 30, 65, 90, 120, 240, 360, 480 min.
Subjective measures-Opiate effect
Time frame: -1, 30, 65, 90, 120, 240, 360, 480 min.
Subjective measures- OVAS
Time frame: -1, 30, 65, 90, 120, 240, 360, 480 min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
Related trials for Opiate Addiction
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures
Hepatitis C, Transmission, Intravenous Drug Abuser
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmin Hurd, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabidiol and Fentanyl in people with Opiate Addiction, run by Hurd,Yasmin, Ph.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety of cannabidiol oral administration prior to fentanyl IV administration. (time frame: 9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013; AzTrials last refreshed its copy on 8 Nov 2026.