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OpenTrials
Completed

NCT Number: NCT01595620

Cannabinoid Modulation of Pain

The purpose of this study is to test the effects of cannabinoids on pain response using a variety of human experimental pain models.

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Key information

Conditions

Pain Chemically-Induced Disorders Marijuana Abuse Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one lifetime exposure to cannabis
  • Acceptable Birth Control methods for females

Exclusion criteria

  • Cannabis naive
  • Medical or psychiatric contraindications
  • Analgesic medication
  • Previous sensitivity to THC or cannabis

Treatment and study plan

Thermal

Other

Thermal sensation/pain testing

Electrical

Other

Electrical sensation/pain testing

Capsaicin

Other

Intradermal Capsaicin

THC

Drug

Active THC (0.01 mg/kg) administered over 10 minutes

Other names: Delta-9-tetrahydrocannabinol

Placebo

Drug

Control: small amount of alcohol with no THC, administered over 10 minutes

Primary outcomes

  1. Capsaicin-induced hyperalgesia

    Time frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration

Secondary outcomes

  1. Pain Measures

    Time frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration

  2. Non-pain subjective responses

    Time frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration

  3. Cognitive subjective responses

    Time frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 10, 2012
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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