Evaluating how CBD interacts with Morphine
Phase 1 Drug-drug Interaction of Cannabidiol and Morphine in Recreational Opioid Users
This study is testing how cannabidiol (CBD) affects the way morphine works in healthy people who have used opioids before.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | National Institute on Drug Abuse (NIDA) NIH |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT05143424 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze the interactions between cannabidiol (CBD) and morphine in healthy individuals who have used opioids recreationally. It is an inpatient, single-blind, non-randomized study that will assess the pharmacokinetics of morphine when administered with and without CBD at two different dosages. The primary goal is to understand how CBD affects the metabolism and effects of morphine, which could have implications for opioid use disorder treatment. Participants will be closely monitored to ensure safety and gather accurate data on drug interactions.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 55 who have a history of recreational opioid use but are not seeking treatment for opioid use disorder.
Not a fit: Patients who are currently seeking treatment for opioid use disorder or have significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer pain management strategies for individuals with opioid use disorder.
How similar studies have performed: While there is ongoing research into CBD and opioid interactions, this specific approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Overland Park, Kansas
- AltaSciences — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Debra Kelsh, MD
- Email: contact@altasciences.com
- Phone: 913-696-1601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.