Opioid Use Disorder
Conditions
Brief summary
This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.
Interventions
DRUGInhaled vaporized cannabis
Double-blind cannabis and placebo doses, administered through vaporizer
DRUGIntransal opioid
Double-blind opioid and placebo doses, administered intranasal route
Sponsors
Shanna Babalonis, PhD
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Current opioid use disorder
Exclusion criteria
* Current medical conditions that require medical management
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS) | Change from baseline | Subjective ratings of opioid withdrawal severity on visual analog scale (scale 0-100; 0 = not at all, 100 = extremely) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS) | Change from baseline | Subjective ratings of drug liking on visual analog scale (scale 0-100, 0 = not at all, 100 = extremely) |
| Change from Baseline - Respiration | Change from baseline | Physiological monitoring of respiration rate (breaths per minute) |
Countries
United States
Contacts
CONTACTPaul Nuzzo, MA
PRINCIPAL_INVESTIGATORShanna Babalonis, PhD
University of Kentucky
Outcome results
None listed