Cannabidiol, Morphine, Pain

Chronic Pain Clinical Trial

— CMP  

Official title:

Human Laboratory Model to Screen Drugs With Opioid Analgesic-sparing Effects: Cannabidiol/Morphine Combinations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04030442
• Other study ID #: CMP
• Status: Recruiting
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: January 26, 2025

Study information

• Verified date: February 2024
• Source: Wayne State University
• Contact: Leslie Lundahl, Ph.D
• Phone: (313)993-3960
• Email: llundahl[@]med.wayne.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the proposed study is to investigate the interaction of cannabidiol (CBD) and morphine effects on pain sensitivity. Cannabidiol is a cannabinoid (similar to cannabis, or marijuana) present in marijuana that alters some of the effects of marijuana.

Description:

Eligible participants will be asked to participate in a total of three experimental sessions with each session day separated by at least one week. Each session day will last approximately 6-7 hours.

In the morning of each of the three study sessions, participants will be asked to complete baseline assessments which include self-report questionnaires (answering questions about how they feel), vital sign measurements (blood pressure, heart rate, oxygen saturation, temperature, and pupillometry) will be taken using a non-invasive (external) vitals monitor, and lastly thermal (heat and cold) and mechanical sensitivity testing will be done.

Participants will be asked to take an oral morphine capsule.

Participants will participate in 2 smoking sessions where they will be asked to smoke cigarettes or a vaporizer balloon containing either cannabidiol or a placebo (a blank).

Participants will be asked to complete the same battery assessments mentioned above, which include self-report questionnaires (answering questions about how they feel); vital sign measurements (blood pressure, heart rate, oxygen saturation, temperature, and pupillometry) will be taken using a non-invasive (external) vitals monitor; and lastly thermal (heat and cold) and mechanical stimulation will be administered to test pain sensitivity.

Participants will be asked to complete subjective questionnaires and have vital signs (blood pressure, heart rate, oxygen saturation, temperature, and pupillometry) measured multiple times throughout the visit; these measurements will be monitored for reasons such as safety.

After completing the second round of smoking and battery assessments, participants will be provided with lunch and can relax, watch television, listen to music, or read.

Once vital signs and questionnaire ratings have returned to baseline levels; participants can leave the laboratory.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 26, 2025
• Est. primary completion date: January 26, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• CBD
• Chronic Pain

Intervention

Drug:
• Immediate-release Oral Morphine Sulfate Tablets
0 mg Immediate release oral morphine; 15 mg Immediate release oral morphine; 30 mg Immediate release oral morphine; Randomized between sessions

Other:
• Thermal and Pressure Nociceptive Sensitivity
Primary outcome measures of pain threshold and tolerance.

Locations

Country	Name	City	State
United States	Tolan Park Medical Building	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHANGE: PAIN THRESHOLD AND TOLERANCE Pain responses to a range of heat, cold and mechanical pressure stimuli	Change in pain threshold and tolerance is being assessed post each CBD drug use (0%and 9.7%) using Q-Sense Conditioned Pain Modulation™. A randomized series of 7 heat stimuli and 7 cold stimuli will be delivered via a thermode attached to the lower nondominant arm. A series of 7 pressure stimuli will be delivered with a pressure algometer to the opposite arm.	Pain responses measured at the start of the visit, baseline; 25 minutes post CBD 0% drug; 25 minutes post CBD 9.7% drug
Secondary	SAFETY: Systolic blood pressure (physiological effects)	Safety is being assessed.	Systolic blood pressure measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).
Secondary	SAFETY: Diastolic blood pressure (physiological effects)	Safety is being assessed.	Diastolic blood pressure measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).
Secondary	SAFETY: Heart rate	Safety is being assessed.	Heart Rate measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).
Secondary	SAFETY: Temperature	Safety is being assessed.	Temperature measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).
Secondary	SAFETY: Oxygen saturation	Safety is being assessed.	Oxygen Saturation measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).
Secondary	SAFETY: Pupillometry Measurement - Diameter of your eye	Safety is being assessed.	Pupillometry measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).
Secondary	SAFETY & INDICES OF ABUSE LIABILITY: Drug Effect	Indices of abuse liability is being assessed. Visual Analog Scales (0="not at all" and 100= "extremely"): "good drug effect," "bad drug effect," "strength of drug effect," liking," "sedated," "high" and "desire to take again."	Drug Liking measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).
Secondary	SAFETY & INDICES OF ABUSE LIABILITY: Drug Symptoms	Drug Symptoms are being assessed, (0="not at all", 1= "a little", 2="moderately", 3="quite a bit" 4= "extremely").	Drug Symptoms measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).
Secondary	SAFETY & INDICES OF ABUSE LIABILITY: Mood and Feeling	Mood and Feeling is being assessed. Visual Analog Scales (0="not at all" and 100= "extremely"): "Anxious", "Sedated", "Hungry", "Stimulated", "Friendly", "High", "Alert", "Happy", "Tired", "Talkative", "Self-Confident", "Down", "Social", "Upset", "Confused", "Good Drug Effect", "Bad Drug Effect", "Dizzy", "Sleep", "Energetic", "Jittery", "Content", "Unmotivated", "Restless", "Forgetful", "Mellow", "Clumsy", "Numbness or tingling in my extremities", "I'm having difficulty concentrating", "I am sweating", "My heart is pounding or beating faster than usual", "Noises or sounds seem louder than usual", "My limbs feel heavier than usual".	Measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).
Secondary	SAFETY & INDICES OF ABUSE LIABILITY: Feelings about self	One's self-evaluation of feelings is being assessed.	Measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).
Secondary	SAFETY & INDICES OF ABUSE LIABILITY: Brief Pain Inventory	One's self-evaluation of pain is being assessed.	Measured at baseline only.