Cannabinoid Modulation of Pain

NCT ID: NCT01595620

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-09

Study Completion Date

2012-04-19

Brief Summary

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

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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THC 0.01 mg/kg

Group Type ACTIVE_COMPARATOR

Thermal

Intervention Type OTHER

Thermal sensation/pain testing

Electrical

Intervention Type OTHER

Electrical sensation/pain testing

Capsaicin

Intervention Type OTHER

Intradermal Capsaicin

THC

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Thermal

Intervention Type OTHER

Thermal sensation/pain testing

Electrical

Intervention Type OTHER

Electrical sensation/pain testing

Capsaicin

Intervention Type OTHER

Intradermal Capsaicin

Placebo

Intervention Type DRUG

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

THC 0.03 mg/kg

Group Type ACTIVE_COMPARATOR

Thermal

Intervention Type OTHER

Thermal sensation/pain testing

Electrical

Intervention Type OTHER

Electrical sensation/pain testing

Capsaicin

Intervention Type OTHER

Intradermal Capsaicin

THC

Intervention Type DRUG

Active THC (0.03 mg/kg) administered over 10 minutes

Interventions

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Thermal

Thermal sensation/pain testing

Intervention Type OTHER

Electrical

Electrical sensation/pain testing

Intervention Type OTHER

Capsaicin

Intradermal Capsaicin

Intervention Type OTHER

THC

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

Intervention Type DRUG

THC

Active THC (0.03 mg/kg) administered over 10 minutes

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Delta-9-tetrahydrocannabinol Delta-9-tetrahydrocannabinol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Deepak C. D'Souza

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deepak C D'Souza, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1005006859

Identifier Type: -

Identifier Source: org_study_id

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