Opioid-use Disorder
Conditions
Brief summary
The purpose of this week-long study is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment.
Detailed description
Studies have indicated that medication treatment for opioid use disorder (OUD) with buprenorphine, methadone, or extended-release naltrexone reduces the risk for overdose by 70%. However, treatment dropout rates remain unacceptably high, with approximately 50% of patients discontinuing treatment 6 months after initiation. There is a substantial body of research indicating that high rates of treatment discontinuation are due to the emergence of intense cravings to use illicit opioids in response to cues - which are reminders of the drug such as drug paraphernalia. Much of the research so far in improving treatment retention on medications for OUD have focused on helping patients learn how to avoid triggers and to manage their cravings if they do emerge, and psychosocial treatments as adjuncts to medications has similarly not been as helpful as hoped. As such, there is a critical need to identify novel strategies that will improve retention in medical treatment for OUD, and cannabidiol (CBD) has emerged as a possible adjunct to OUD treatment, as it appears to target brain regions that mediate cue-induced cravings. Two studies so far have shown that CBD reduces cue-induced cravings for abstinent individuals with OUD not taking any medications, but the impact of CBD on cue-induced cravings among individuals stabilized on buprenorphine is not known. Given that long-term medication treatment remains the gold-standard approach, a critical question that remains unanswered is whether CBD can be used as an adjunct to buprenorphine treatment to reduce cue-induced cravings. As such, the purpose of this week-long open-label feasibility pilot is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment. Patients with OUD currently receiving treatment with sublingual buprenorphine will be eligible to enroll. The cue-induced cravings assessment will be conducted before and after the CBD administration.
Interventions
DRUGCannabidiol 600mg
All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) opioid use disorder, severe * Currently in treatment with methadone or buprenorphine
Exclusion criteria
* Requiring level of care higher than outpatient treatment for alcohol, sedative/hypnotics, or stimulants * Any current mood episode requiring level of care higher than outpatient treatment * History of psychotic disorder or bipolar disorder * Currently pregnant * Hepatic liver enzymes greater than 3x upper normal limit * Hypersensitivity to cannabinoids or sesame oil (cannabidiol solution comes in sesame oil emulsion) * Currently taking any medications with known significant pharmacokinetic interactions with CBD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration | pre-exposure (Visit 2, which is day 2 of the 5-day study) and post-exposure (Visit 3, which is day 5 of the 5-day study) | Change in cue-induced cravings and anxiety measured before and after 3 days of cannabidiol administration. Subjects will use the Cue-Induced Opioid Craving and Anxiety Scales to note their responses using a visual analog scale of 0 to 10, 0 being not at all and 10 being extremely. Higher scores thus mean a worse outcome (i.e. more intense cravings/anxiety). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cannabidiol As this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically 600mg of oral cannabidiol once daily for 3 consecutive days.
Cannabidiol 600mg: All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Cannabidiol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 37.86 years STANDARD_DEVIATION 8.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration
Change in cue-induced cravings and anxiety measured before and after 3 days of cannabidiol administration. Subjects will use the Cue-Induced Opioid Craving and Anxiety Scales to note their responses using a visual analog scale of 0 to 10, 0 being not at all and 10 being extremely. Higher scores thus mean a worse outcome (i.e. more intense cravings/anxiety).
Time frame: pre-exposure (Visit 2, which is day 2 of the 5-day study) and post-exposure (Visit 3, which is day 5 of the 5-day study)
Population: Individuals with opioid use disorder who are currently receiving buprenorphine for treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol | Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration | Cannabidiol | 3.2 score on a scale | Standard Deviation 0.8 |
| Cannabidiol | Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration | Pre-CBD | 0.4 score on a scale | Standard Deviation 0.5 |