Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

New York State Psychiatric Institute

Status and phase: Completed; Phase 1

Conditions: Abuse, Drug; Pain

Treatments: Drug: Placebo; Drug: Cannabis (THC:CBD = ~ 1:0); Drug: Cannabis (THC:CBD = ~ 1:1); Drug: Cannabis (THC:CBD = ~ 0:1); Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT03679949

7647

Details and patient eligibility

About

The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.

Enrollment: 26 patients

Sex: All

Ages: 21 to 53 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or non-pregnant female aged 21-53 years
• Previous cannabis use
• Previous opioid use
• Urine test positive for recent cannabis use
• Being able to perform all study procedures
• Currently practicing an effective form of birth control (women only)

Exclusion criteria

• Meeting criteria for some Use Disorders
• Report regular illicit drug use
• If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process revealed any significant illness

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 8 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized)

Treatment:

Drug: Placebo

Oxycodone

Experimental group

Description:

Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)

Treatment:

Drug: Oxycodone

Drug: Placebo

Cannabis (THC:CBD = ~1:0)

Experimental group

Description:

Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)

Treatment:

Drug: Cannabis (THC:CBD = ~ 1:0)

Drug: Placebo

Cannabis (THC:CBD = ~ 0:1)

Experimental group

Description:

Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)

Treatment:

Drug: Cannabis (THC:CBD = ~ 0:1)

Drug: Placebo

Cannabis (THC:CBD = ~ 1:1)

Experimental group

Description:

Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized)

Treatment:

Drug: Cannabis (THC:CBD = ~ 1:1)

Drug: Placebo

Cannabis (THC:CBD = ~1:0) + Oxycodone

Experimental group

Description:

Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)

Treatment:

Drug: Oxycodone

Drug: Cannabis (THC:CBD = ~ 1:0)

Cannabis (THC:CBD = ~ 0:1) + Oxycodone

Experimental group

Description:

Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)

Treatment:

Drug: Oxycodone

Drug: Cannabis (THC:CBD = ~ 0:1)

Cannabis (THC:CBD = ~ 1:1) + Oxycodone

Experimental group

Description:

Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized)

Treatment:

Drug: Oxycodone

Drug: Cannabis (THC:CBD = ~ 1:1)