Investigating the effects of cannabidiol and morphine on pain sensitivity
Human Laboratory Model to Screen Drugs With Opioid Analgesic-sparing Effects: Cannabidiol/Morphine Combinations
This study is testing how taking cannabidiol (CBD) along with morphine affects how people feel pain.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Wayne State University Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT04030442 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how cannabidiol (CBD) interacts with morphine to affect pain sensitivity in participants. Eligible individuals will attend three experimental sessions, each lasting 6-7 hours, where they will undergo various assessments including self-report questionnaires, vital sign measurements, and pain sensitivity testing. Participants will take oral morphine and smoke either CBD or a placebo during the sessions to evaluate the combined effects on pain perception. The study will also include thorough medical and psychiatric evaluations to ensure participant safety.
Who should consider this trial
Good fit: Ideal candidates are individuals who have a history of smoking cigarettes or marijuana and have taken opioids on multiple occasions.
Not a fit: Patients with serious psychiatric illnesses, substance use disorders (other than nicotine or mild cannabis), or significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies by understanding the interaction between CBD and morphine.
How similar studies have performed: While there is ongoing research into the effects of cannabinoids on pain, this specific combination of CBD and morphine is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must report having smoked a cigarette (nicotine or marijuana) AND having taken an opioid on 3 or more occasions in their lifetime. * Participants must be in good health to participate; those with certain contraindications will be excluded. * All participants will undergo psychiatric evaluation and will be asked to report their substance use history by interview and structured questionnaire methods. * Participants will undergo medical evaluations using medical history, physical exam, standard lab tests (complete blood chemistry, urinalysis, urine pregnancy test for females), and 12-lead ECG. Exclusion Criteria: * Serious psychiatric illness (e.g. psychotic or bipolar disorder, recent suicide attempts; severe depression) * Substance Use Disorders other than Nicotine Use Disorder and Mild Cannabis Use Disorder * Neurological diseases; cardiovascular problems (e.g. systolic BP \>140 or \<95 mmHg, diastolic BP \>90 mmHg, abnormal ECG); pulmonary diseases; systemic diseases (e.g. liver, renal, inflammatory) * Cognitive impairment (\<80 IQ) * Past-month medications that increase study risk * Women who are pregnant (urine HCG), lactating (self-report), or if heterosexually active and not using (self-report) medically approved birth control (oral or depot contraception, IUD, condom/foam, sterilization, tubal ligation) * Individuals unable to give informed consent will be excluded.
Where this trial is running
Detroit, Michigan
- Tolan Park Medical Building — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Leslie Lundahl, PhD — Wayne State University
- Study coordinator: Leslie Lundahl, Ph.D
- Email: llundahl@med.wayne.edu
- Phone: (313)993-3960
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.