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Cannabidiol, Morphine, Pain (CMP)

Primary Purpose

CBD, Chronic Pain

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Immediate-release Oral Morphine Sulfate Tablets
Thermal and Pressure Nociceptive Sensitivity
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for CBD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Sites / Locations

  • Tolan Park Medical BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Smoked cannabidiol 0%

Smoked cannabidiol 3.4%

Smoked cannabidiol 12.7%

Arm Description

Outcomes

Primary Outcome Measures

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%, 3.4% and 12.7%) using a Medoc 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.

Secondary Outcome Measures

SAFETY Systolic blood pressure (physiological effects)
Safety is being assessed.
SAFETY Diastolic blood pressure (physiological effects)
Safety is being assessed.
SAFETY Heart rate
Safety is being assessed.
SAFETY Respiratory rate
Safety is being assessed.
SAFETY Oxygen saturation
Safety is being assessed.
INDICES OF ABUSE LIABILITY Drug Liking
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."
INDICES OF ABUSE LIABILITY Economic demand (drug purchase task (DPT)
Indices of abuse liability is being assessed. Participants will be asked to make drug purchases based on how they feel at the moment (each DPT assessment is independent from the last CBD cumulative dose received). They will be informed that the amount purchased at each drug unit price (independent observations) must be consumed within 24-hr (i.e., participants cannot save or stockpile drug). Unit prices (UPs) per drug dose will be: $0 (free; no constraint) and $0.01, $0.10, $0.50, $1, $3, $5, $7.50, $10, $12.50, $15, $20, $25, $30, $35, $40, $45, $50, $60, $80 and $100.

Full Information

First Posted
June 17, 2019
Last Updated
June 30, 2021
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT04030442
Brief Title
Cannabidiol, Morphine, Pain
Acronym
CMP
Official Title
Human Laboratory Model to Screen Drugs With Opioid Analgesic-sparing Effects: Cannabidiol/Morphine Combinations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CBD, Chronic Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smoked cannabidiol 0%
Arm Type
Placebo Comparator
Arm Title
Smoked cannabidiol 3.4%
Arm Type
Active Comparator
Arm Title
Smoked cannabidiol 12.7%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Immediate-release Oral Morphine Sulfate Tablets
Intervention Description
0 mg Immediate release oral morphine; 15 mg Immediate release oral morphine; 30 mg Immediate release oral morphine; Randomized between sessions
Intervention Type
Other
Intervention Name(s)
Thermal and Pressure Nociceptive Sensitivity
Intervention Description
Primary outcome measures of pain threshold and tolerance.
Primary Outcome Measure Information:
Title
CHANGE. PAIN THRESHOLD AND TOLERANCE Pain responses to a range of heat, cold and mechanical pressure stimuli
Description
Change in pain threshold and tolerance is being assessed post each CBD drug use (0%, 3.4% and 12.7%) using a Medoc 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 15 minutes post CBD 0% drug using (1015); 15 minutes post CBD 3.4% drug using (11:15); 15 minutes post 12.7% CBD drug using (1155)
Secondary Outcome Measure Information:
Title
SAFETY Systolic blood pressure (physiological effects)
Description
Safety is being assessed.
Time Frame
Systolic blood pressure measured at baseline (0845); 15 minutes post CBD 0% drug using (1015); 15 minutes post CBD 3.4% drug using (11:15); 15 minutes post 12.7% CBD drug using (1155); 155 minutes post final CBD drug using (1430)
Title
SAFETY Diastolic blood pressure (physiological effects)
Description
Safety is being assessed.
Time Frame
Diastolic blood pressure measured at baseline (0845); 15 minutes post CBD 0% drug using (1015); 15 minutes post CBD 3.4% drug using (11:15); 15 minutes post 12.7% CBD drug using (1155); 155 minutes post final CBD drug using (1430
Title
SAFETY Heart rate
Description
Safety is being assessed.
Time Frame
Heart Rate measured at baseline (0845); 15 minutes post CBD 0% drug using (1015); 15 minutes post CBD 3.4% drug using (11:15); 15 minutes post 12.7% CBD drug using (1155); 155 minutes post final CBD drug using (1430)
Title
SAFETY Respiratory rate
Description
Safety is being assessed.
Time Frame
Respiratory rate measured at baseline (0845); 15 minutes post CBD 0% drug using (1015); 15 minutes post CBD 3.4% drug using (11:15); 15 minutes post 12.7% CBD drug using (1155); 155 minutes post final CBD drug using (1430)
Title
SAFETY Oxygen saturation
Description
Safety is being assessed.
Time Frame
Oxygen Saturation measured at baseline (0845); 15 minutes post CBD 0% drug using (1015); 15 minutes post CBD 3.4% drug using (11:15); 15 minutes post 12.7% CBD drug using (1155); 155 minutes post final CBD drug using (1430)
Title
INDICES OF ABUSE LIABILITY Drug Liking
Description
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 (0845); 15 minutes post CBD 0% drug using (1015); 15 minutes post CBD 3.4% drug using (11:15); 15 minutes post 12.7% CBD drug using (1155); 155 minutes post final CBD drug usin
Title
INDICES OF ABUSE LIABILITY Economic demand (drug purchase task (DPT)
Description
Indices of abuse liability is being assessed. Participants will be asked to make drug purchases based on how they feel at the moment (each DPT assessment is independent from the last CBD cumulative dose received). They will be informed that the amount purchased at each drug unit price (independent observations) must be consumed within 24-hr (i.e., participants cannot save or stockpile drug). Unit prices (UPs) per drug dose will be: $0 (free; no constraint) and $0.01, $0.10, $0.50, $1, $3, $5, $7.50, $10, $12.50, $15, $20, $25, $30, $35, $40, $45, $50, $60, $80 and $100.
Time Frame
Economic demand will be measured at 40 minutes post CBD 0% drug using (1040); 40 minutes post CBD 3.4% drug using (1130); 40 minutes post CBD 12.7% drug using (1210)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alina Woodford
Phone
(313) 993-3960
Email
awoodford@med.wayne.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Lundahl, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tolan Park Medical Building
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Lundahl, PhD
Phone
313-993-3960
Email
llundahl@med.wayne.edu

12. IPD Sharing Statement

Learn more about this trial

Cannabidiol, Morphine, Pain

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