Cannabinoid Modulation of Pain

Yale University

Status and phase: Completed; Early Phase 1

Conditions: Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01595620

1005006859

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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6 participants in 3 patient groups, including a placebo group

THC 0.01 mg/kg

Active Comparator group

Treatment:

Other: Thermal

Drug: THC

Other: Capsaicin

Other: Electrical

Drug: THC

Placebo

Placebo Comparator group

Treatment:

Other: Thermal

Other: Capsaicin

Other: Electrical

Drug: Placebo

THC 0.03 mg/kg

Active Comparator group

Treatment:

Other: Thermal

Drug: THC

Other: Capsaicin

Other: Electrical

Drug: THC