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Cannabidiol, Morphine, Pain (CMP)

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ClinicalTrials.gov Identifier: NCT04030442
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Leslie Lundahl, Wayne State University

Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE July 24, 2019
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
CHANGE. PAIN THRESHOLD AND TOLERANCE Pain responses to a range of heat, cold and mechanical pressure stimuli [ 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) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • SAFETY Systolic blood pressure (physiological effects) [ 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) ]
    Safety is being assessed.
  • SAFETY Diastolic blood pressure (physiological effects) [ 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 ]
    Safety is being assessed.
  • SAFETY Heart rate [ 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) ]
    Safety is being assessed.
  • SAFETY Respiratory rate [ 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) ]
    Safety is being assessed.
  • SAFETY Oxygen saturation [ 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) ]
    Safety is being assessed.
  • INDICES OF ABUSE LIABILITY Drug Liking [ 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 ]
    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) [ 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) ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol, Morphine, Pain
Official Title  ICMJE Human Laboratory Model to Screen Drugs With Opioid Analgesic-sparing Effects: Cannabidiol/Morphine Combinations
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • CBD
  • Chronic Pain
Intervention  ICMJE
  • Drug: 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
  • Other: Thermal and Pressure Nociceptive Sensitivity
    Primary outcome measures of pain threshold and tolerance.
Study Arms  ICMJE
  • Placebo Comparator: Smoked cannabidiol 0%
    Interventions:
    • Drug: Immediate-release Oral Morphine Sulfate Tablets
    • Other: Thermal and Pressure Nociceptive Sensitivity
  • Active Comparator: Smoked cannabidiol 3.4%
    Interventions:
    • Drug: Immediate-release Oral Morphine Sulfate Tablets
    • Other: Thermal and Pressure Nociceptive Sensitivity
  • Active Comparator: Smoked cannabidiol 12.7%
    Interventions:
    • Drug: Immediate-release Oral Morphine Sulfate Tablets
    • Other: Thermal and Pressure Nociceptive Sensitivity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alina Woodford (313) 993-3960 awoodford@med.wayne.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04030442
Other Study ID Numbers  ICMJE CMP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leslie Lundahl, Wayne State University
Study Sponsor  ICMJE Wayne State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leslie Lundahl, PhD Wayne State University
PRS Account Wayne State University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP