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Evaluation of the Interactions of Cannabidiol (CBD) With Morphine

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ClinicalTrials.gov Identifier: NCT05143424
Recruitment Status : Recruiting
First Posted : December 3, 2021
Last Update Posted : February 21, 2022
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

Brief Summary:
The purpose of this study is to analyze drug-drug interactions of CBD on co-administered Morphine as first step in understanding CBD-opioid interactions.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: Morphine Sulfate Phase 1

Detailed Description:
This is an inpatient, single-blind, non-randomized, 1-sequence study involving healthy subjects who have used opioids for recreational use. The primary objective of the study is to establish the pharmacokinetic parameters of morphine 30 mg when administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Phase 1 Drug-drug Interaction of Cannabidiol and Morphine in Recreational Opioid Users
Actual Study Start Date : November 4, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Active Comparator: CBD (350 mg)
CBD 350 mg twice per day for 3 days
Drug: Morphine Sulfate
Morphine sulfate 30 mg tablets as a single dose twice
Other Names:
  • Placebo oral capsule
  • Placebo

Active Comparator: CBD (700 mg)
CBD 700 mg twice per day for 3 days
Drug: Morphine Sulfate
Morphine sulfate 30 mg tablets as a single dose twice
Other Names:
  • Placebo oral capsule
  • Placebo




Primary Outcome Measures :
  1. Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD [ Time Frame: 3 day ]
    Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.

  2. Establish the Area Under the Curve (AUC 0-t) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD [ Time Frame: 3 day ]
    Establish the Area Under the Curve (AUC 0-t) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.

  3. Establish the Area Under the Curve from zero to infinity (AUC 0-inf) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD [ Time Frame: 3 day ]
    Establish the Area Under the Curve from zero to infinity (AUC 0-inf) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.


Secondary Outcome Measures :
  1. Establish the Time of Maximum Plasma Concentration (Tmax) of morphine when administered orally with and without CBD [ Time Frame: 3 day ]
    Establish the Time of Maximum Plasma Concentration (Tmax) of morphine when administered orally with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.

  2. Establish the Terminal Phase Elimination Rate Constant of morphine when administered orally with and without CBD [ Time Frame: 3 day ]
    Establish the Terminal Phase Elimination Rate Constant of morphine when administered orally with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.

  3. Establish the Apparent Clearance of morphine when administered orally with and without CBD [ Time Frame: 3 day ]
    Establish the Apparent Clearance of morphine when administered orally with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.

  4. Establish the Maximum Plasma Concentration (Cmax) of CBD when administered orally with morphine [ Time Frame: 3 day ]
    Establish the Maximum Plasma Concentration (Cmax) of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine

  5. Establish the Time of Maximum Plasma Concentration (Tmax) of CBD when administered orally with morphine [ Time Frame: 3 day ]
    Establish the Time of Maximum Plasma Concentration (Tmax) of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine

  6. Establish the Area Under the Curve of the dosing period of CBD when administered orally with morphine [ Time Frame: 3 day ]
    Establish the Area Under the Curve of the dosing period of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine

  7. Establish the Apparent Clearance of CBD when administered orally with morphine [ Time Frame: 3 day ]
    Establish the Apparent Clearance of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine

  8. Establish the terminal half-life of CBD when administered orally with morphine [ Time Frame: 3 day ]
    Establish the terminal half-life of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine

  9. Establish the terminal-phase elimination rate constant of CBD when administered orally with morphine [ Time Frame: 3 day ]
    Establish the terminal-phase elimination rate constant of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine

  10. Safety and Tolerability of morphine when administered orally with or without CBD by collecting vital signs and recording treatment emergent adverse events [ Time Frame: 7 + 3/5 days ]

    Incidence of treatment Emergent Adverse Events using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) preferred terms, its relationship to the treatment, and maximum severity, either reported by the subject or by clinically significant abnormal findings on:

    i. Physical examination ii. Rate of change in vital signs assessments of heart rate, sitting blood pressure, respiration rate, and temperature iii. Rate of change in ECG assessment iv. Rate of change in venous CO2 concentrations v. Rate of clinical laboratory changes




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures.
  • Males and females 18 to 55 years of age, inclusive.
  • Body mass index (BMI) ranging from 18 to 34 kg/m2, inclusive, and body weight of 56 kg and above.
  • Adequate venous access as assessed by an investigator at screening.
  • No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
  • Recreational opioid use (i.e., defined as prescription opioid use for nontherapeutic purposes on at least 3 occasions within the previous year and at least once in the 12 weeks prior to screening), experienced in using opioids of approximately 30 mg morphine equivalents and not seeking treatment for Opioid Use Disorder.
  • If of childbearing potential, a female study subject must agree to use 1 of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study and for at least 30 days after the last dose of the study medication

    1. An acceptable method of contraception includes abstinence from heterosexual intercourse or intrauterine device (with or without hormones)
    2. OR agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication. Oral contraceptives are prohibited.
    3. If a female of non-childbearing potential, she should be surgically sterile (i.e., has undergone compete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by FSH level.
  • A male study subject must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication.
  • Agree not to ingest alcohol, drinks containing caffeine >500 mg/day (e.g., Coca Cola®, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.
  • Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
  • Must be willing and able to abide by all study requirements and restrictions.

Exclusion Criteria:

  • Contact site directly for more information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05143424


Contacts
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Contact: Debra Kelsh, MD 913-696-1601 contact@altasciences.com

Locations
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United States, Kansas
AltaSciences Recruiting
Overland Park, Kansas, United States, 66212
Contact: Debra Kelsh, MD    913-696-1601    contact@altasciences.com   
Principal Investigator: Debra Kelsh, MD         
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT05143424    
Other Study ID Numbers: NIDA-CBD-Phase1a-002
First Posted: December 3, 2021    Key Record Dates
Last Update Posted: February 21, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute on Drug Abuse (NIDA):
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Depressants
Psychotropic Drugs
Neurotransmitter Agents
Cannabidiol
CBD
Morphine
Molecular Mechanisms of Pharmacological Action
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents