Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

This is an interventional treatment trial for Opioid-use Disorder focused on measuring Buprenorphine, Cannabidiol, Opioid Use disorder Read More

Inclusion Criteria:

1. Ability to read and speak English and has provided written informed consent.

1. Age between 18 and 65 years (inclusive).
2. Have an opiate use disorder that meets criteria set in the Mini-International Neuropsychiatric Interview (MINI 7.0.2) for DSM-5 ≥ three months before screening.
3. On a stable dose of 12-16 mg buprenorphine, either alone, or in combination with naloxone (buprenorphine/naloxone ratio of 4/1) for at least 7 days prior to starting and for the duration of the treatment phase of the study.
4. Self-report of opioid use in the 30 days before screening; verified by treatment center records.
5. If female, being surgically sterile or willing to use birth control (e.g., oral contraceptives, condoms, intrauterine device) or willingness to abstain from sex throughout the study.
6. Body Mass Index (BMI) between 17.5 and 35 kg/m2; total body weight > 110 lb (50 kg).
7. Currently in residential treatment at the Tarzana Treatment Center.

Exclusion Criteria:

1. History of sensitivity to a CBD product or any of the ingredients in the study drug, including glycerin or gelatin.
2. A condition that may affect drug absorption (e.g., gastrectomy).
3. Taking a medications that has clinically significant interactions with CBD or are contraindicated for the study (check with study physician).
4. Meeting criteria for a substance use disorder, moderate or severe, other than OUD or Tobacco Use Disorder in the 3 months prior to screening.
5. Positive urine test for THC at screening.
6. Self-report of using CBD at screening.
7. PK analysis at screening showing evidence of CBD use (any level > 0).
8. Physiological dependence on alcohol or a sedative-hypnotic benzodiazepine drug.
9. Current medication-assisted treatment with methadone or naltrexone.
10. Acute opioid withdrawal symptoms, as defined by a score on the COWS > 4.
11. Clinical laboratory finding of AST or ALT > 3 times the upper limit of normal (ULN) or bilirubin > 1.5 times ULN.
12. AIDS or HIV positive status (because treatment medications have potential interactions with CBD).
13. Pregnancy or lactation.
14. Clinically significant EKG abnormalities, as determined by the study physician, including the following: QTc >450 msec (men) or >470 (women) or QRS interval >120 msec (If QTc or QRS interval exceed these cutoff points, EKG will be repeated twice and the average of the three QTc values used to determine eligibility.), congenital long QT syndrome, history of prolonged QT in the 3 months before screening, corrected QT interval (Fridericia's - QTcF) >450 msec (male) or >470 msec (female) or history of risk factors for Torsades de Pointes.
15. For women: any value outside reference ranges on a hormonal battery [estradiol, follicle-stimulating hormone, free thyroxine index, luteinizing hormone, prolactin, T3 uptake, thyroid-stimulating hormone, and thyroxine], followed by an abnormal ovarian ultrasound finding.
16. Clinically significant cardiovascular, hematologic, hepatic, renal, or endocrine abnormalities, as determined by the study physician.
17. Meeting criteria on the MINI for schizophrenia, Bipolar I disorder, psychotic disorder, having active suicidal ideation, or suicide attempt in the past 12 months. Or, answers "yes" to questions 4 or 5 on C-SSRS. NOTE: Participants with other psychiatric conditions, such as major depression, generalized anxiety, dysthymia, social phobia or specific phobia may be enrolled in the study if they are clinically stable.
18. On the cue-induced opiate craving task at screening, the participant does not have a score of at least 50 (on a visual analogue scale with a maximum score of 100) for at least one image within one category. Note: Groups of images may be separated into smoking cues, pills and bottles, and injection paraphernalia. For example, for injection cues, a picture of a needle and syringe may elicit a craving response, though other images in the same group (i.e., picture of arm with vein bulging) do not elicit craving.