Evaluation of the Interactions of Cannabidiol (CBD) With Morphine

NCT ID: NCT05143424

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2024-12-01

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.

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.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

CBD (350 mg)

CBD 350 mg twice per day for 3 days

Group Type: ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type: DRUG

Morphine sulfate 30 mg tablets as a single dose twice

CBD (700 mg)

CBD 700 mg twice per day for 3 days

Group Type: ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type: DRUG

Morphine sulfate 30 mg tablets as a single dose twice

Interventions

Morphine Sulfate

Morphine sulfate 30 mg tablets as a single dose twice

Intervention Type: DRUG

Other Intervention Names

Placebo oral capsule; Placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AltaSciences

Overland Park, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Debra Kelsh, MD

Role: CONTACT

contact@altasciences.com

913-696-1601

Facility Contacts

Debra Kelsh, MD

Role: primary

contact@altasciences.com

913-696-1601

Other Identifiers

NIDA-CBD-Phase1a-002

Identifier Type: -

Identifier Source: org_study_id