RECRUITING

Combined THC and CBD for OUD and Chronic Pain

Conditions

Chronic Pain Opioid Use Disorder Delta-9-Tetrahydrocannabinol Cannabidiol Cannabinoid Methadone Opioid Addiction Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Combination of THC and CBD as Novel Treatment for Co-Occurring Opioid Use Disorder and Chronic Pain

Quick Facts

Study Start:2024-10-22

Study Completion:2028-01-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06544291

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female aged 18-65 years. 4. 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). 5. 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. 6. Adherence to their clinically prescribed methadone therapy, on a stable dose (30-150 mg/day ≥ 3 weeks). 7. 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 last test session. 8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.	1. Meeting DSM-5 criteria for cannabis use disorder and/or substance use disorders (SUDs) other than OUD or tobacco use disorder, within the last 12 months. 2. 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). 3. 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. 4. Contraindications for exposure to nociceptive stimuli, such as untreated hypertension, verbally noted by participant or verified during screening procedures. 5. Abnormal screening EKG (QTc interval \>450 ms), arrythmia, or vasospastic disease. 6. 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 partner. 7. Currently lactating. 8. Male participants who plan to donate sperm starting at screening and through 90 days after final study drug administration. 9. Females who plan to donate ova starting at screening through 28 days after final study drug administration. 10. History of primary psychotic disorders or mood disorders with psychotic features. 11. Current suicidal ideation or related behavior. 12. 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 inhibitors (SNRIs) (e.g. venlafaxine, duloxetine), gabapentinoids, tricyclic antidepressants (e.g., nortriptyline, amitriptyline), anticonvulsant medications (e.g., topiramate, carbamazepine). Only participants who are on stable doses (i.e., consistent daily administration of the medication for at least three months at the same dose following the last dose change, either increase or decrease) of these medications, and whose dosing schedules allow participation in the study visits, thus excluding instances of single-dose or temporary dosing of the medication, will be eligible as determined by the sponsor-investigator. If possible, the morning dose will be administered after the study visit. 13. Current, regular use of benzodiazepines, other prescription opioids, or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor). 14. Allergy or serious adverse reaction to cannabis or its constituent cannabinoid. 15. Allergy or serious adverse reaction to sesame oil or seeds. 16. Allergy or serious adverse reaction to Butylated Hydroxytoluene (BHT). 17. Unable to swallow or have difficulty swallowing capsules. 18. 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 ≤ 50 mg/mL. If a participant tests greater than ≤ 50 mg/mL, they will be asked to abstain for an additional 7 to 14 days. If 14 days after their initial THC concentration test the participant continues to test positive, they will not be allowed to participate in the study.

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female aged 18-65 years.
4. 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).
5. 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.
6. Adherence to their clinically prescribed methadone therapy, on a stable dose (30-150 mg/day ≥ 3 weeks).
7. 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 last test session.
8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

1. Meeting DSM-5 criteria for cannabis use disorder and/or substance use disorders (SUDs) other than OUD or tobacco use disorder, within the last 12 months.
2. 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).
3. 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.
4. Contraindications for exposure to nociceptive stimuli, such as untreated hypertension, verbally noted by participant or verified during screening procedures.
5. Abnormal screening EKG (QTc interval \>450 ms), arrythmia, or vasospastic disease.
6. 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 partner.
7. Currently lactating.
8. Male participants who plan to donate sperm starting at screening and through 90 days after final study drug administration.
9. Females who plan to donate ova starting at screening through 28 days after final study drug administration.
10. History of primary psychotic disorders or mood disorders with psychotic features.
11. Current suicidal ideation or related behavior.
12. 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 inhibitors (SNRIs) (e.g. venlafaxine, duloxetine), gabapentinoids, tricyclic antidepressants (e.g., nortriptyline, amitriptyline), anticonvulsant medications (e.g., topiramate, carbamazepine). Only participants who are on stable doses (i.e., consistent daily administration of the medication for at least three months at the same dose following the last dose change, either increase or decrease) of these medications, and whose dosing schedules allow participation in the study visits, thus excluding instances of single-dose or temporary dosing of the medication, will be eligible as determined by the sponsor-investigator. If possible, the morning dose will be administered after the study visit.
13. Current, regular use of benzodiazepines, other prescription opioids, or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor).
14. Allergy or serious adverse reaction to cannabis or its constituent cannabinoid.
15. Allergy or serious adverse reaction to sesame oil or seeds.
16. Allergy or serious adverse reaction to Butylated Hydroxytoluene (BHT).
17. Unable to swallow or have difficulty swallowing capsules.
18. 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 ≤ 50 mg/mL. If a participant tests greater than ≤ 50 mg/mL, they will be asked to abstain for an additional 7 to 14 days. If 14 days after their initial THC concentration test the participant continues to test positive, they will not be allowed to participate in the study.

Contacts and Locations

Study Contact

Julia V. Meyerovich, M.S.

CONTACT

203-932-5711

julia.meyerovich@yale.edu

Joao P. De Aquino, M.D.

CONTACT

203-623-7493

joao.deaquinolima@yale.edu

Principal Investigator

Joao P. De Aquino, M.D.

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Connecticut Mental Health Center

New Haven, Connecticut, 06519

United States

Collaborators and Investigators

Sponsor: Yale University

Joao P. De Aquino, M.D., PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-22

Study Completion Date2028-01-28

Study Record Updates

Study Start Date2024-10-22

Study Completion Date2028-01-28

Terms related to this study

Keywords Provided by Researchers

Delta-9-Tetrahydrocannabinol
Cannabidiol
Cannabinoid
Methadone
Opioid Addiction
Pain

Additional Relevant MeSH Terms

Chronic Pain
Opioid Use Disorder