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Cannabinoid
Marijuana + Opioid Interaction for Substance Use Disorders
Phase 1
Recruiting
Research Sponsored by Shanna Babalonis, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18-50
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-dose during each session (change from baseline is assessed); visual analog scales will be the primary measure (0-100, 0=not at all, 100=extremely)
Awards & highlights
No Placebo-Only Group
Summary
This trial examines how marijuana and oxycodone affect each other when taken together, and at different doses.
Who is the study for?
This trial is for adults aged 18-50 who have used marijuana and opioids before, are generally healthy, and can stay at the University of Kentucky Hospital research unit for about 6.5 weeks with meals provided. People with significant medical conditions cannot participate.
What is being tested?
The study is looking into how marijuana affects the use of oxycodone (a type of opioid) and vice versa. Participants will be given different doses of each drug in a controlled environment to see how one influences the desire or effects of the other.
What are the potential side effects?
Possible side effects may include drowsiness, dizziness, nausea, confusion from opioids; and dry mouth, red eyes, increased appetite or short-term memory issues from marijuana.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-dose during each session (change from baseline is assessed)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-dose during each session (change from baseline is assessed)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Self-Administration
Secondary study objectives
Blood pressure
Heart rate
Subjective measures
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Double-blind opioid/placebo administrationExperimental Treatment2 Interventions
Participants will receive double-blind administration of intranasal opioid agonist/placebo
Group II: Double-blind marijuana/placebo administrationExperimental Treatment2 Interventions
Participants will receive double-blind administration of vaporized marijuana/placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Opioid
2008
Completed Phase 4
~2450
Marijuana
2008
Completed Phase 2
~340
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Shanna Babalonis, PhDLead Sponsor
3 Previous Clinical Trials
99 Total Patients Enrolled
1 Trials studying Cannabis Use
10 Patients Enrolled for Cannabis Use
National Institute on Drug Abuse (NIDA)NIH
2,592 Previous Clinical Trials
3,328,668 Total Patients Enrolled
34 Trials studying Cannabis Use
7,396 Patients Enrolled for Cannabis Use
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