Cannabidiol Morphine Pain

  • STATUS
    Recruiting
  • End date
    Dec 1, 2021
  • participants needed
    40
  • sponsor
    Wayne State University
Updated on 26 January 2021
morphine
opioid
oral morphine

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 answer questions about how they feel and vital signs (blood pressure, heart rate, oxygen saturation, and temperature) will be measured using a non-invasive (external) vitals monitor.

Participants will be asked to take an oral morphine capsule.

Participants will participant in 3 smoking sessions where they will be asked to smoke cigarettes containing either cannabidiol or placebo (a blank).

Participant's response to different intensities of thermal (heat and cold) stimulation will be administered to test pain sensitivity.

Participants will be asked to complete questionnaires and have vital signs (blood pressure, heart rate) monitored.

After completing the third round of smoking and assessment battery, 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.

Details
Condition Pain, Cannabidiol, Carbidopa, Chronic Pain, Post-Surgical Pain, Pain (Pediatric), chronic pains
Treatment Immediate-release Oral Morphine Sulfate Tablets, Thermal and Pressure Nociceptive Sensitivity
Clinical Study IdentifierNCT04030442
SponsorWayne State University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 55 yrs?
Gender: Male or Female
Do you have any of these conditions: Carbidopa or Post-Surgical Pain or Pain or Chronic Pain or Pain (Pediatric)?
Do you have any of these conditions: Carbidopa or Pain (Pediatric) or Chronic Pain or Post-Surgical Pain or Cannabidiol or chronic pains or Pain?
Participants must report having smoked a cigarette (nicotine or marijuana) AND having taken an opioid > 3 occasions lifetime
Participants must be in good health to participate; those with 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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