Cannabidiol, Morphine, Pain

NCT04030442 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CMP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

CBD; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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

  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

  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

  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).

Study Arms (2)

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

Interventions

Immediate-release Oral Morphine Sulfate Tablets DRUG

0 mg Immediate release oral morphine; 15 mg Immediate release oral morphine; 30 mg Immediate release oral morphine; Randomized between sessions

Smoked cannabidiol 0%; Smoked cannabidiol 9.7%

Thermal and Pressure Nociceptive Sensitivity OTHER

Primary outcome measures of pain threshold and tolerance.

Smoked cannabidiol 0%; Smoked cannabidiol 9.7%

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Tolan Park Medical Building

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leslie Lundahl, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Lundahl, Ph.D

CONTACT

(313)993-3960; llundahl@med.wayne.edu

Nareen Sadik, B.S

CONTACT

313-993-3960; fw6362@wayne.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: July 24, 2019
• Study Start: May 1, 2019
• Primary Completion: January 26, 2025
• Study Completion: January 26, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

US (1)