Evaluation of the Interactions of Cannabidiol (CBD) With Morphine

NCT05143424 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NIDA-CBD-Phase1a-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD

  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.

  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

  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 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

  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.

  3 day

Secondary Outcomes (10)

• Establish the Time of Maximum Plasma Concentration (Tmax) of morphine when administered orally with and without CBD

  3 day

• Establish the Terminal Phase Elimination Rate Constant of morphine when administered orally with and without CBD

  3 day

• Establish the Apparent Clearance of morphine when administered orally with and without CBD

  3 day

• Establish the Maximum Plasma Concentration (Cmax) of CBD when administered orally with morphine

  3 day

• Establish the Time of Maximum Plasma Concentration (Tmax) of CBD when administered orally with morphine

  3 day

Study Arms (2)

CBD (350 mg)

ACTIVE COMPARATOR

CBD 350 mg twice per day for 3 days

Drug: Morphine Sulfate

CBD (700 mg)

ACTIVE COMPARATOR

CBD 700 mg twice per day for 3 days

Drug: Morphine Sulfate

Interventions

Morphine Sulfate DRUG

Morphine sulfate 30 mg tablets as a single dose twice

Also known as: Placebo oral capsule, Placebo

CBD (350 mg); CBD (700 mg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• An acceptable method of contraception includes abstinence from heterosexual intercourse or intrauterine device (with or without hormones)
• 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.
• 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.

You may not qualify if:

• Contact site directly for more information

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

AltaSciences

Overland Park, Kansas, 66212, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Marijuana Abuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Interventions

Morphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Debra Kelsh, MD

CONTACT

913-696-1601; contact@altasciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 3, 2021
• Study Start: November 4, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

US (1)