Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2025-01-22
2029-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Smoked THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
THC 30mg
High dose of THC (30 mg)
THC 5mg
Low dose of THC (5 mg)
THC 0mg
Placebo dose of THC (0 mg)
Cigarette Full Nicotine
Full nicotine cigarette
Cigarette Reduced Nicotine
Reduced nicotine cigarette
Vaporized THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
THC 30mg
High dose of THC (30 mg)
THC 5mg
Low dose of THC (5 mg)
THC 0mg
Placebo dose of THC (0 mg)
Cigarette Full Nicotine
Full nicotine cigarette
Cigarette Reduced Nicotine
Reduced nicotine cigarette
Interventions
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THC 30mg
High dose of THC (30 mg)
THC 5mg
Low dose of THC (5 mg)
THC 0mg
Placebo dose of THC (0 mg)
Cigarette Full Nicotine
Full nicotine cigarette
Cigarette Reduced Nicotine
Reduced nicotine cigarette
Eligibility Criteria
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Inclusion Criteria
2. Report daily use of combustible tobacco cigarettes
3. Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 5 ppm and a positive urine cotinine test at screening
4. Report current use of cannabis (at least 1 occasion per week)
5. Have experience with the inhalation route of administration for cannabis
6. Biological confirmation of cannabis use: have a positive urinary THC drug test at screening.
7. For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study.
Exclusion Criteria
2. Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
3. Test positive for illicit drugs other than cannabis and tobacco
4. Positive breath alcohol test at study admission
5. Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
6. Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
7. Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding
8. Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
9. Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
21 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Dustin Lee, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine
Locations
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Johns Hopkins University Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00435111
Identifier Type: -
Identifier Source: org_study_id
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