Cannabinoid Modulation of Pain

NCT01595620 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 1005006859
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Cannabis; THC; Pain

Outcome Measures

Primary Outcomes (1)

• Capsaicin-induced hyperalgesia

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

Secondary Outcomes (3)

• Pain Measures

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

• Non-pain subjective responses

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

• Cognitive subjective responses

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

Study Arms (3)

THC 0.01 mg/kg

ACTIVE COMPARATOR

Other: Thermal; Other: Electrical; Other: Capsaicin; Drug: THC

Placebo

PLACEBO COMPARATOR

Other: Thermal; Other: Electrical; Other: Capsaicin; Drug: Placebo

THC 0.03 mg/kg

ACTIVE COMPARATOR

Other: Thermal; Other: Electrical; Other: Capsaicin; Drug: THC

Interventions

Thermal OTHER

Thermal sensation/pain testing

Placebo; THC 0.01 mg/kg; THC 0.03 mg/kg

Electrical OTHER

Electrical sensation/pain testing

Placebo; THC 0.01 mg/kg; THC 0.03 mg/kg

Capsaicin OTHER

Intradermal Capsaicin

Placebo; THC 0.01 mg/kg; THC 0.03 mg/kg

THC DRUG

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

Also known as: Delta-9-tetrahydrocannabinol

THC 0.01 mg/kg

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Pain; Marijuana Abuse

Interventions

Electricity; Capsaicin; Dronabinol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Cannabinoids; Terpenes

Study Officials

• Deepak C D'Souza, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: May 10, 2012
• Study Start: November 9, 2011
• Primary Completion: April 19, 2012
• Study Completion: April 19, 2012
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

US (1)