Opioid Use Clinical Trial
Official title:
Interactions of Marijuana and Opioids: Pharmacodynamic Effects
Verified date | February 2024 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Shanna Babalonis, PhD | National Institute on Drug Abuse (NIDA) |
United States,
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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