Status:
COMPLETED
Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research aims to determine the effects and safety of cannabidiol (CBD) (ATL5 softgel capsules) as an adjunctive therapy for patients who have Opioid Use Disorder and are taking buprenorphine + na...
Detailed Description
This will be a randomized, double-blind, placebo controlled, study of cannabidiol (CBD) (600 mg/day) as an adjunctive therapy to buprenorphine + naloxone or methadone in patients who have Opioid Use D...
Eligibility Criteria
Inclusion
- Ability to read and speak English and has provided written informed consent.
- Age of 18-65 years (inclusive).
- Meeting criteria for an OUD according to the MINI for ≥ 3 months before screening.
- Self-report of opioid use in the 60 days before screening; verified by treatment center records.
- On a stable dose of ≥12 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. OR, receiving methadone maintenance therapy for at least 7 days prior to starting and for the duration of the treatment phase of the study.
- 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.
- Body Mass Index (BMI) between 17.5 and 35 kg/m2; total body weight \> 110 lb (50 kg).
- Currently in residential treatment at the Tarzana Treatment Center.
Exclusion
- History of sensitivity to a CBD product or any of the ingredients in the study drug, including glycerin or gelatin.
- A condition that may affect drug absorption (e.g., gastrectomy).
- Taking a medications that has clinically significant interactions with CBD or are contraindicated for the study (check with study physician).
- Positive urine test for THC at screening.
- Self-report of using CBD at screening.
- PK analysis at screening showing evidence of CBD use (a signal that is ≥ three times the background noise at the corresponding CBD retention time and MS2 transition).
- Physiological dependence on alcohol or a sedative-hypnotic benzodiazepine drug.
- Current medication-assisted treatment with naltrexone.
- Acute opioid withdrawal symptoms, as defined by a score on the COWS \> 4.
- Clinical laboratory finding of AST or ALT \> 3 times the upper limit of normal (ULN) or bilirubin \> 1.5 times ULN.
- AIDS or HIV positive status (because treatment medications have potential interactions with CBD).
- Pregnancy or lactation.
- 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.
- 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.
- Clinically significant cardiovascular, hematologic, hepatic, renal, or endocrine abnormalities, as determined by the study physician.
- 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.
- On the cue-induced opiate craving task at screening, the participant does not have a score of at least 25 (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.
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03787628
Start Date
May 19 2022
End Date
March 12 2024
Last Update
August 1 2025
Active Locations (1)
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1
Tarzana Treatment Centers
Tarzana, California, United States, 91356