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New treatment option for Pain
Official title Effects of Dronabinol in Opioid Maintained Patients
ClinicalTrials.gov ID: NCT04025359
What this study is testing
What is Dronabinol?
Dronabinol is an investigational medicine, given as an once-daily, being studied as a potential treatment for pain.
Also referred to as Marinol.
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
- Twenty male and female (ages 18-70) participants with OUD currently receiving methadone or buprenorphine will be enrolled. Prior to their daily methadone or buprenorphine dose and thus at trough plasma levels of opioid, participants will receive dronabinol (2.5 mg, 5mg) or placebo.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 70
You may be able to join if
- Prior exposure to THC or cannabis at least once in the last 10 years; 1-10 times in the last 20 years; or more than 20 times in their lifetime.
- Males and females, Veterans and non-Veterans, aged between 18 and 70.
- Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
- Capable of providing informed consent in English.
- Compliant in opioid maintenance treatment and on a stable dose for two weeks or longer.
You likely can't join if
- Currently meeting DSM-5 criteria for cannabis use disorder (CUD).
- History of primary psychotic disorders or other current major psychiatric disorders deemed clinically unstable by the principal investigator.
- Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal...
- Inability to complete neuropsychological tests.
- A physician will carefully evaluate participants for use of over-the-counter or prescription psychoactive drugs known to affect pain threshold or...
- Liver function tests (ALT or AST) greater than 3x normal.
See the full eligibility criteria
- Prior exposure to THC or cannabis at least once in the last 10 years; 1-10 times in the last 20 years; or more than 20 times in their lifetime.
- Males and females, Veterans and non-Veterans, aged between 18 and 70.
- Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
- Capable of providing informed consent in English.
- Compliant in opioid maintenance treatment and on a stable dose for two weeks or longer.
- Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
- No current medical problems deemed contraindicated for participation by principal investigator.
- For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods.
- Currently meeting DSM-5 criteria for cannabis use disorder (CUD).
- History of primary psychotic disorders or other current major psychiatric disorders deemed clinically unstable by the principal investigator.
- Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator.
- Inability to complete neuropsychological tests.
- A physician will carefully evaluate participants for use of over-the-counter or prescription psychoactive drugs known to affect pain threshold or pain tolerance (including NSAIDS, serotonin-norepinephrine reuptake...
- Liver function tests (ALT or AST) greater than 3x normal.
- Contraindications for exposure to cold temperatures, such as Raynaud's phenomenon and hypertension.
- Allergy or serious adverse reaction to cannabis, dronabinol or other cannabinoids.
The study team makes the final eligibility decision.
Where it's taking place
- West Haven, Connecticut, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Haven, Connecticut, 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.