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Opioid and Cannabinoid Interactions

S

Shanna Babalonis, PhD

Status and phase

Completed
Phase 1

Conditions

Marijuana Usage
Opioid Use

Treatments

Drug: Vaporized Marijuana
Drug: Opioid Agonist
Drug: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03705559
R01DA045700 (U.S. NIH Grant/Contract)
45017

Details and patient eligibility

About

This study will examine the effects of doses of marijuana/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

Enrollment

10 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Healthy adults ages 18-50
  • Current non-medical use of opioids and marijuana

Exclusion criteria

  • Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics
  • Seeking treatment for drug use
  • Significant medical problems

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

10 participants in 4 patient groups, including a placebo group

Vaporized Marijuana
Experimental group
Description:
Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.
Treatment:
Drug: Placebo
Drug: Vaporized Marijuana
Opioid Agonist
Experimental group
Description:
Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).
Treatment:
Drug: Placebo
Drug: Opioid Agonist
Opioid Agonist/Marijuana Combination
Experimental group
Description:
Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
Treatment:
Drug: Opioid Agonist
Drug: Vaporized Marijuana
Placebo
Placebo Comparator group
Description:
Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Shanna Babalonis, Ph.D.

Data sourced from clinicaltrials.gov

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