Safety and Effects on Responses to Stress and Pain of Natural Medical Marijuana Products

NCT04226690 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2000020896No NIH funding
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal aims to systematically examine the safety and pharmacokinetic/pharmacodynamic profile and the physiologic, neuroendocrine and behavioral stress and pain responses to acute single doses and repeated dosing of oral tablet formulation of natural Cannabidiol (CBD) alone and in combination with Tetrahydrocannabinol and matched Placebo (PLA).

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain Ratings

  Change in provoked pain ratings on day 1 and day 7 on visual analog scale of pain (range 0-10)

  Day 1 and 7 provocation during 7-day treatment period

Secondary Outcomes (1)

• Anxiety Ratings

  Day 1 and 7 provocation during 7-day treatment period

Other Outcomes (2)

• Pain Intensity Ratings

  Baseline, 7-day treatment period and during 2 week follow-up

• Sleep disturbance Ratings

  Baseline, 7-day treatment period and during 2 week follow-up

Study Arms (3)

Active Dose 1

EXPERIMENTAL

Participants will receive the most tolerable CBD/THC dose with repeated dosing for 7 days. On day 1 and 6/7 of the 7-day dosing, subjects will complete laboratory sessions.

Drug: Active CBD/THC Dose 1

Matching Placebo

PLACEBO COMPARATOR

Participants will receive a placebo with repeated dosing for 7 days. On day 1 and 6/7 of the 7-day dosing, subjects will complete laboratory sessions.

Drug: matched placebo comparator

Active Dose 2

EXPERIMENTAL

Participants will receive the second most tolerable CBD/THC dose with repeated dosing for 7 days. On day 1 and 6/7 of the 7-day dosing, subjects will complete laboratory sessions

Drug: Active CBD/THC Dose 2

Interventions

Active CBD/THC Dose 1 DRUG

Subjects will self-administer the assigned study medication daily at home after pickup and will be tested using medication compliance procedures. Subjects will visit the center 2 times in the 7-day period on days 1 and 7 for blood draws to assess medication compliance.

Also known as: Medical marijuana medicine

Active Dose 1

Active CBD/THC Dose 2 DRUG

Subjects will self-administer the assigned study medication daily at home after pickup and will be tested using medication compliance procedures. Subjects will visit the center 2 times in the 7-day period on days 1 and 7 for blood draws to assess medication compliance.

Also known as: Medical marijuana medicine

Active Dose 2

matched placebo comparator DRUG

Subjects will self-administer the assigned study medication daily at home after pickup and will be tested using medication compliance procedures. Subjects will visit the center 2 times in the 7-day period on days 1 and 7 for blood draws to assess medication compliance.

Also known as: Placebo

Matching Placebo

Eligibility Criteria

• Age: 21 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read and write English;
• Recreational cannabis use with a minimum history recent use of at least one joint of smoked marijuana or marijuana edible or other equivalent form;
• Current chronic pain, as defined by the International Classification of Diseases (ICD)-10, and stabilized for a minimum of 2 weeks on pain medication, (minimum pain ratings of 4 on a 10-point scale) and agree to not change pain medication during course of the study;
• Body Mass Index (BMI) in the 18-36 range;

You may not qualify if:

• Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation.
• Any Current moderate/severe Substance Use Disorder, including alcohol and cannabis.
• Women who are nursing or have premenstrual dysphoric disorder;
• Women who are pregnant as determined by the urine pregnancy test at each assessment period;
• Inability to give informed consent;
• Traumatic brain injury or loss of consciousness;
• Individuals with current or past history of seizure disorders;

Sponsors & Collaborators

• Yale University: lead
• Connecticut Pharmaceutical Solutions: collaborator

Study Sites (1)

The Yale Stress Center: Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo controlled, parallel group design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: November 15, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

US (1)