Cannabidiol as Adjunctive Treatment for Opioid Use Disorder

• Status: Not yet recruiting
• Trial end date: 2023-11-15
• Target enrollment: 0
• Participant gender: All

Summary

This research aims to determine the effects and safety of cannabidiol (CBD) as an adjunctive therapy for patients, who have Opioid Use Disorder and are taking buprenorphine + naloxone. Buprenorphine + naloxone is an approved treatment for Opioid Use Disorder, but relapse to opioid misuse is common among patients who receive this treatment. Finding an adjunctive treatment that does not have abuse liability and reduces relapse for these patients would be helpful.

Investigators will recruit participants from the Tarzana Treatment Center in Los Angeles. They will be receiving buprenorphine + naloxone as part of residential therapy. Potential participants who pass initial screening and wish to continue in the study will provide written, informed consent and will complete a screening evaluation, including blood and urine tests, questionnaires about their mood, medical, psychiatric and drug use history and a physical exam.

Sixty participants who meet all eligibility criteria will be invited to complete baseline assessments (blood and urine tests, questionnaires), and will be assigned randomly to receive CBD or placebo in each of three cohorts, corresponding to two dose groups of 20 participants per cohort (CBD 600, 1200mg/day). Within each cohort, 20 participants will receive CBD and 10 will receive placebo. The cohorts will be studied in ascending dose order to ensure safety.

Each day, participants will take the study medication twice daily under supervision. Questionnaires on opioid craving, withdrawal, and mood symptoms will be administered daily during the treatment period. Cue-induced craving will be assessed at 3 timepoints (days 0, 7 and 28). PK samples will be assessed at multiple time-points during the study.

After the 28-day intervention, participants will complete questionnaires and undergo urine drug tests in weekly follow-up visits (days 29-56). PK samples will be assessed at multiple time-points during the follow-up period.

The study will last ~9 weeks, comprising three periods: a screening period (~7 days during which participants are stabilized on buprenorphine + naloxone in residential treatment at Tarzana Treatment Center), a treatment period (4 weeks when study CBD or placebo is administered at UCLA), and a follow-up period (4 weeks after termination of the test intervention).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Analgesics, Opioid; Buprenorphine; Cannabidiol; Pharmaceutical Solutions

Criteria

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.