RECRUITING

Evaluation of the Interactions of Cannabidiol (CBD) With Morphine

Conditions

Opioid Use Disorder 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1 Drug-drug Interaction of Cannabidiol and Morphine in Recreational Opioid Users

Quick Facts

Study Start:2021-11-04

Study Completion:2024-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05143424

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* Contact site directly for more information

Inclusion Criteria

Exclusion 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.

* Contact site directly for more information

Contacts and Locations

Study Contact

Debra Kelsh, MD

CONTACT

913-696-1601

contact@altasciences.com

Study Locations (Sites)

AltaSciences

Overland Park, Kansas, 66212

United States

Collaborators and Investigators

Sponsor: National Institute on Drug Abuse (NIDA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-04

Study Completion Date2024-12-01

Study Record Updates

Study Start Date2021-11-04

Study Completion Date2024-12-01

Terms related to this study

Keywords Provided by Researchers

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

Opioid Use Disorder