CBDPhase 1CMPNCT04030442
Cannabidiol, Morphine, Pain
A Phase 1 study testing Immediate-release Oral Morphine Sulfate Tablets and Thermal and Pressure Nociceptive Sensitivity in people with CBD and Chronic Pain, run by Wayne State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- CBD, Chronic Pain
- What is being tested?
- Immediate-release Oral Morphine Sulfate Tablets and Thermal and Pressure Nociceptive Sensitivity
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 26 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tolan Park Medical Building
Detroit, Michigan, 48201
Leslie Lundahl, PhD, 313-993-3960, llundahl@med.wayne.edu
About this study
Official title: Human Laboratory Model to Screen Drugs With Opioid Analgesic-sparing Effects: Cannabidiol/Morphine Combinations
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.
Read the detailed 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.
- Conditions
- CBD, Chronic Pain
- Being tested
- Immediate-release Oral Morphine Sulfate Tablets, Thermal and Pressure Nociceptive Sensitivity
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate-release Oral Morphine Sulfate TabletsDrug
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 SensitivityOther
Primary outcome measures of pain threshold and tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Smoked cannabidiol 0% | Placebo comparator | Not described Receives: Drug: Immediate-release Oral Morphine Sulfate Tablets; Other: Thermal and Pressure Nociceptive Sensitivity |
| Smoked cannabidiol 9.7% | Active comparator | Not described Receives: Drug: Immediate-release Oral Morphine Sulfate Tablets; Other: Thermal and Pressure Nociceptive Sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pain responses measured at the start of the visit, baseline; 25 minutes post CBD 0% drug; 25 minutes post CBD 9.7% drug
Secondary outcomes (11)
SAFETY: Systolic blood pressure (physiological effects)
Safety is being assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Safety is being assessed.
Measured: 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.
Measured: 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."
Measured: 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").
Measured: 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".
Measured: 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.
Measured: 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.
Measured: Measured at baseline only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 May 2019
- Primary completion26 Jan 2025 (estimated)
- Study completion26 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Lundahl, Wayne State University
- Investigators
- Leslie Lundahl, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030442
- Sponsor's protocol ID
- CMP
- Acronym
- CMP
- Status last verified
- Feb 2024
- First submitted
- 17 Jun 2019
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Laboratory Model to Screen Drugs With Opioid Analgesic-sparing Effects: Cannabidiol/Morphine Combinations
- ClinicalTrials.gov ID
- NCT04030442
- Acronym / sponsor ID
- CMP / CMP
- Conditions
- CBD, Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 26 Jan 2025 (estimated)
- Study completion
- 26 Jan 2025 (estimated)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoked cannabidiol 0% | Placebo comparator | Drug: Immediate-release Oral Morphine Sulfate Tablets, Other: Thermal and Pressure Nociceptive Sensitivity |
| Smoked cannabidiol 9.7% | Active comparator | Drug: Immediate-release Oral Morphine Sulfate Tablets, Other: Thermal and Pressure Nociceptive Sensitivity |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate-release Oral Morphine Sulfate Tablets0 mg Immediate release oral morphine; 15 mg Immediate release oral morphine; 30 mg Immediate release oral morphine; Randomized between sessions | Drug | Smoked cannabidiol 0%, Smoked cannabidiol 9.7% |
| Thermal and Pressure Nociceptive SensitivityPrimary outcome measures of pain threshold and tolerance. | Other | Smoked cannabidiol 0%, Smoked cannabidiol 9.7% |
Primary outcome
CHANGE: PAIN THRESHOLD AND TOLERANCE Pain responses to a range of heat, cold and mechanical pressure stimuli
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
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.
11 secondary outcomes
SAFETY: Systolic blood pressure (physiological effects)
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)
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
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
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
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
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
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
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
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
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
Time frame: Measured at baseline only.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Lundahl, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Immediate-release Oral Morphine Sulfate Tablets and Thermal and Pressure Nociceptive Sensitivity in people with CBD and Chronic Pain, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leslie Lundahl, Ph.D ((313)993-3960, llundahl@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHANGE: PAIN THRESHOLD AND TOLERANCE Pain responses to a range of heat, cold and mechanical pressure stimuli (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.