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New treatment option for Pain
Official title Age-dependent Effects of Smoked and Oral Delta-9-THC
ClinicalTrials.gov ID: NCT05865470
What this study is testing
What is Cannabis?
Cannabis is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pain.
Also referred to as Smoked cannabis with THC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS...
- Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening
- Not currently seeking treatment for their cannabis use
- No reported clinically significant adverse effects with cannabis use
- Have a Body Mass Index from 18.5 - 34kg/m2
You likely can't join if
- Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis...
- Report using other illicit drugs in the prior 4 weeks
- Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e...
- Current predominant licit use of medical cannabis
- Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement...
- If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range...
See the full eligibility criteria
- Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS: 35-45 years of age (+/- one year) LATE MIDDLE-AGED ADULTS: 55-65 years...
- Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening
- Not currently seeking treatment for their cannabis use
- No reported clinically significant adverse effects with cannabis use
- Have a Body Mass Index from 18.5 - 34kg/m2
- Able to perform all study procedures
- FEMALES: Currently practicing an effective form of birth control if pre-menopausal
- Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis use disorder
- Report using other illicit drugs in the prior 4 weeks
- Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e., hypertension) judged by the study physician (and PI to put the...
- Current predominant licit use of medical cannabis
- Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement therapy). Current use of herbal supplements that may affect study...
- If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged...
- Current pain
- Pregnancy is exclusionary due to the possible effects of the study medication on fetal development
- History of an allergic reaction or adverse reaction to cannabis is exclusionary.
- Currently enrolled in another research protocol
- Not using a contraceptive method (hormonal or barrier methods)
- The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
- Intolerance to lactose and sesame (ingredients in the oral THC preparation)
- Insensitivity to the Cold Pressor Test
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.