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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03705559
Other study ID # 45017
Secondary ID R01DA045700
Status Completed
Phase Phase 1
First received
Last updated
Start date June 21, 2019
Est. completion date February 15, 2024

Study information

Verified date February 2024
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date February 15, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vaporized Marijuana
Active Marijuana or Placebo, administered through vaporizer
Opioid Agonist
Active Opioid Agonist or Placebo, administered intranasally

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (2)

Lead Sponsor Collaborator
Shanna Babalonis, PhD National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Subject-Rated Outcomes Participants will rate their subjective drug effects (ex: drug liking, high) on standardized VAS scales. These outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Secondary Change in Oxygen Saturation Oxygen saturation (measured as a percentage) will be monitored throughout each session. Oxygen saturation will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Secondary Change in Respiration Rate Respiration rate (number of breaths per minute) Respiration rate will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Secondary Change in Blood pressure Systolic and diastolic blood pressure (mm Hg) Blood pressure will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
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