Recruiting
Phase 1

Cannabidiol & Morphine

Sponsor:

Wayne State University

Code:

NCT04030442

Conditions

CBD

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Immediate-release Oral Morphine Sulfate Tablets

Thermal and Pressure Nociceptive Sensitivity

Study Details

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

Study ID

NCT04030442

Start date

May 1, 2019

Status verified date

Feb, 2024

Completion date

Jan 26, 2025

Anticipated

Primary completion date

Jan 26, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Smoked cannabidiol 0%

active comparator: Smoked cannabidiol 9.7%

Interventions

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

Thermal and Pressure Nociceptive Sensitivity

Primary outcome measures of pain threshold and tolerance.

Primary outcome measure

  • CHANGE: PAIN THRESHOLD AND TOLERANCE Pain responses to a range of heat, cold and mechanical pressure stimuli [ Time Frame: Pain responses measured at the start of the visit, baseline; 25 minutes post CBD 0% drug; 25 minutes post CBD 9.7% drug ]

Central Contacts and Locations

Central contacts

Leslie Lundahl, Ph.D

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

Nareen Sadik, B.S

313-993-3960fw6362@wayne.edu

Locations

Tolan Park Medical Building

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Leslie Lundahl, PhD

313-993-3960llundahl@med.wayne.edu

More Information

Sponsor

Wayne State University

Last update posted

Feb 29, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2024-02-29.