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New treatment option for Chronic Pain
Official title Combined THC and CBD for OUD and Chronic Pain
ClinicalTrials.gov ID: NCT06544291
What this study is testing
What is CBD 300mg?
CBD 300mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic pain.
Also referred to as Nantheia™ ATL5 (300mg).
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
- The primary objective of this phase 2 study is to investigate the therapeutic potential of orally administered combined delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in relieving both pain and cue-induced opioid craving in people with co-occurring opioid use disorder (OUD) and chronic pain who are undergoing methadone therapy.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. 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 65
You may be able to join if
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 18-65 years.
- Co-occurring OUD (meeting DSM-5 criteria) and chronic pain (uniformly operationalized as high-impact [occurring most days, limiting life or work...
- Prior exposure to cannabis or its constituent cannabinoids at least once in the last 10 years, 1-10 times in the last 20 years, or more than 20 times...
You likely can't join if
- Meeting DSM-5 criteria for cannabis use disorder and/or substance use disorders (SUDs) within the last 3 months. Participants meeting DSM-5 criteria...
- Clinically significant medical disorders as noted by the participant or through study screening procedures (e.g. liver dysfunction, as indicated by...
- Neurological conditions that may change the response to nociceptive stimuli (e.g., stroke, neuropathy), or that lead to loss of balance, evidenced by...
- Contraindications for exposure to nociceptive stimuli, such as untreated hypertension, verbally noted by participant or verified during screening...
- Abnormal screening EKG (QTc interval \>450 ms), arrythmia, or vasospastic disease.
- Positive urine pregnancy test, or lack of birth control measures in women of childbearing potential. For males of reproductive potential refusal to...
See the full eligibility criteria
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 18-65 years.
- Co-occurring OUD (meeting DSM-5 criteria) and chronic pain (uniformly operationalized as high-impact [occurring most days, limiting life or work activities] non-cancer low back pain for ≥ 3 months).
- Prior exposure to cannabis or its constituent cannabinoids at least once in the last 10 years, 1-10 times in the last 20 years, or more than 20 times in lifetime.
- Adherence to their clinically prescribed methadone therapy, on a stable dose (30-150 mg/day ≥ 3 weeks).
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
- Meeting DSM-5 criteria for cannabis use disorder and/or substance use disorders (SUDs) within the last 3 months. Participants meeting DSM-5 criteria for OUD and/or tobacco use disorder, either currently or within the...
- Clinically significant medical disorders as noted by the participant or through study screening procedures (e.g. liver dysfunction, as indicated by ALT and/or AST \> 1.5 times the normal limit).
- Neurological conditions that may change the response to nociceptive stimuli (e.g., stroke, neuropathy), or that lead to loss of balance, evidenced by a neuro-sensory exam during screening.
- Contraindications for exposure to nociceptive stimuli, such as untreated hypertension, verbally noted by participant or verified during screening procedures.
- Abnormal screening EKG (QTc interval \>450 ms), arrythmia, or vasospastic disease.
- Positive urine pregnancy test, or lack of birth control measures in women of childbearing potential. For males of reproductive potential refusal to use condoms or other methods to ensure effective contraception with...
- Currently lactating.
- Male participants who plan to donate sperm starting at screening and through 90 days after final study drug administration.
- Females who plan to donate ova starting at screening through 28 days after final study drug administration.
- History of primary psychotic disorders or mood disorders with psychotic features.
- Current suicidal ideation or related behavior.
- 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...
- Current, regular use of benzodiazepines, other prescription opioids, or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor).
- Allergy or serious adverse reaction to cannabis or its constituent cannabinoid.
- Allergy or serious adverse reaction to sesame oil or seeds.
- Allergy or serious adverse reaction to Butylated Hydroxytoluene (BHT).
- Unable to swallow or have difficulty swallowing capsules.
- Prior to receiving the study medication on the first test session, participants' cannabinoid use will be assessed using a quantitative point-of-care urine 11-nor-9-carboxy-THC concentration test with a cut-off of ≤ 150...
The study team makes the final eligibility decision.
Where it's taking place
- New 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New 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.