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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
0 mg Immediate release oral morphine; 15 mg Immediate release oral morphine; 30 mg Immediate release oral morphine; Randomized between sessions
Primary outcome measures of pain threshold and tolerance.
Tolan Park Medical Building
Detroit, Michigan, United States
RECRUITINGCHANGE: 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.
Time frame: Pain responses measured at the start of the visit, baseline; 25 minutes post CBD 0% drug; 25 minutes post CBD 9.7% drug
SAFETY: Systolic blood pressure (physiological effects)
Safety is being assessed.
Time frame: 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).
SAFETY: Diastolic blood pressure (physiological effects)
Safety is being assessed.
Time frame: 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).
SAFETY: Heart rate
Safety is being assessed.
Time frame: 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).
SAFETY: Temperature
Safety is being assessed.
Time frame: 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).
SAFETY: Oxygen saturation
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Safety is being assessed.
Time frame: 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).
SAFETY: Pupillometry Measurement - Diameter of your eye
Safety is being assessed.
Time frame: 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).
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."
Time frame: 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).
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").
Time frame: 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).
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".
Time frame: 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).
SAFETY & INDICES OF ABUSE LIABILITY: Feelings about self
One's self-evaluation of feelings is being assessed.
Time frame: 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).
SAFETY & INDICES OF ABUSE LIABILITY: Brief Pain Inventory
One's self-evaluation of pain is being assessed.
Time frame: Measured at baseline only.