- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01311778
Study to Test the Safety and Efficacy of Cannabidiol as a Treatment Intervention for Opioid Relapse
Cannabidiol as Treatment Intervention for Opioid Relapse
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10029
- Mount Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- being aged between 21 and 65 years old.
- having exposure at least once to an opioid (i.e. codeine, morphine, Fentanyl) in the past
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Subjects will receive placebo
|
All subjects will receive 0.5 mcg/kg and 1mcg/kg of Fentanyl (test session 1 and test session 2)
Other Names:
|
Experimental: CBD 400 mg
Subjects will receive 400 mg CBD
|
All subjects will receive 0.5 mcg/kg and 1mcg/kg of Fentanyl (test session 1 and test session 2)
Other Names:
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. |
Experimental: CBD 800mg
Subjects will receive 800 mg CBD
|
All subjects will receive 0.5 mcg/kg and 1mcg/kg of Fentanyl (test session 1 and test session 2)
Other Names:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General cannabidiol pharmacokinetics
Time Frame: 9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480
|
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).
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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
|
Variation in plasma levels of cortisol will be measured at various time points.
|
-10 min, 30, 60, 90, 120, 180, 240, 360, 480
|
Cannabidiol clearance
Time Frame: 5 timepoints: -60 min, 45, 120, 240, 480
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Urine will be taken at specified times to estimate cannabidiol concentration in order to assess clearance and excretion functions.
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5 timepoints: -60 min, 45, 120, 240, 480
|
Vital signs-BP
Time Frame: -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min
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Blood pressure (mmHg) will be monitored and change from baseline will be studied across the multiple time points.
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-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
|
Heart rate (beats/minute) will be monitored and change from baseline will be studied across the multiple time points.
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-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
|
respiratory rate (respirations/minute) will be monitored and change from baseline will be studied across the multiple time points.
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-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
|
% oxygen saturation will be monitored and change from baseline will be studied across the multiple time points.
|
-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
|
body temperature (degrees Fahrenheit) will be monitored and change from baseline will be studied across the multiple time points.
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-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
|
EKG will be monitored and change from baseline will be studied across the multiple time points.
|
-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.
|
Questionnaires will be used to measure subjective responses.
Anxiety will be assessed using a visual analog scale (VAS).
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-1, 30, 65, 90, 120, 240, 360, 480 min.
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Subjective measures-PANAS
Time Frame: -1, 30, 65, 90, 120, 240, 360, 480 min.
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Questionnaires will be used to measure subjective responses.
The PANAS (Positive and Negative Affect Schedule) will allow obtaining positive and negative affect measures.
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-1, 30, 65, 90, 120, 240, 360, 480 min.
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Subjective measures-Opiate effect
Time Frame: -1, 30, 65, 90, 120, 240, 360, 480 min.
|
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.
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-1, 30, 65, 90, 120, 240, 360, 480 min.
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Subjective measures- OVAS
Time Frame: -1, 30, 65, 90, 120, 240, 360, 480 min.
|
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.
|
-1, 30, 65, 90, 120, 240, 360, 480 min.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yasmin Hurd, PhD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anticonvulsants
- Fentanyl
- Cannabidiol
Other Study ID Numbers
- R21DA027781 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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