Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2019-05-01
2025-01-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Smoked cannabidiol 0%
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
Thermal and Pressure Nociceptive Sensitivity
Primary outcome measures of pain threshold and tolerance.
Smoked cannabidiol 9.7%
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
Thermal and Pressure Nociceptive Sensitivity
Primary outcome measures of pain threshold and tolerance.
Interventions
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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
Thermal and Pressure Nociceptive Sensitivity
Primary outcome measures of pain threshold and tolerance.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Wayne State University
OTHER
Responsible Party
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Leslie Lundahl
Associate Professor
Principal Investigators
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Leslie Lundahl, PhD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
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Tolan Park Medical Building
Detroit, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMP
Identifier Type: -
Identifier Source: org_study_id
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