Cannabidiol, Morphine, Pain

Last updated: February 27, 2024
Sponsor: Wayne State University
Overall Status: Active - Recruiting

Phase

1

Condition

Chronic Pain

Progressive Supranuclear Palsy

Pain

Treatment

Immediate-release Oral Morphine Sulfate Tablets

Thermal and Pressure Nociceptive Sensitivity

Clinical Study ID

NCT04030442
CMP
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must report having smoked a cigarette (nicotine or marijuana) AND havingtaken an opioid on 3 or more occasions in their lifetime.
  • Participants must be in good health to participate; those with certaincontraindications will be excluded.
  • All participants will undergo psychiatric evaluation and will be asked to report theirsubstance 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 forfemales), and 12-lead ECG.

Exclusion

Exclusion Criteria:

  • Serious psychiatric illness (e.g. psychotic or bipolar disorder, recent suicideattempts; severe depression)
  • Substance Use Disorders other than Nicotine Use Disorder and Mild Cannabis UseDisorder
  • 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 heterosexuallyactive and not using (self-report) medically approved birth control (oral or depotcontraception, IUD, condom/foam, sterilization, tubal ligation)
  • Individuals unable to give informed consent will be excluded.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Immediate-release Oral Morphine Sulfate Tablets
Phase: 1
Study Start date:
May 01, 2019
Estimated Completion Date:
January 26, 2025

Study 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.

Connect with a study center

  • Tolan Park Medical Building

    Detroit, Michigan 48201
    United States

    Active - Recruiting

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