Opioid Use Disorder, Stimulant Use Disorder
Conditions
Keywords
Orexin receptor antagonist, Suvorexant, Cocaine, Opioid, Opiate, Heroin, Fentanyl, Nonmedical opioid use, Methadone, Buprenorphine, Suboxone, Polysubstance use, Co-use, Substance-related disorders, Narcotic-related disorders, Chemically-induced disorders, Sleep, Stress, Opioid-related disorders, Stimulant-related disorders, Cocaine use disorder
Brief summary
This study will evaluate whether Suvorexant 20mg reduces drug use and craving, and improves sleep and stress among persons with co-occurring opioid use disorder and stimulant use disorder.
Detailed description
This between-subjects, double-blinded, randomized controlled pilot study will recruit patients who are receiving methadone or buprenorphine treatment for OUD and are using cocaine. Participants will be randomly assigned to receive up to 30-days of Suvorexant (SUVO) or placebo. They will visit the clinic regularly to provide urine drug screens and complete questionnaires and will wear a device that can measure their sleep parameters. We expect that relative to persons who receive placebo, individuals who receive SUVO will 1) be less likely to screen positive for cocaine and/or opioids on urine drug screens, 2) will report lower drug craving, 3) will have longer total sleep time, 4) will report fewer insomnia symptoms, and 5) will report overall lower stress than persons who receive placebo. We also expect that patients will not have side effects from SUVO. These preliminary data will inform whether this FDA-approved medication may help patients stop co-using opioids and stimulants, which can be scaled up to reduce public health consequences related to co-use.
Interventions
Participants will be prescribed up to 30 days of SUVO.
DRUGPlacebo
Participants will be prescribed up to 30 days of placebo medication.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The research pharmacy will manage all randomization and blinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 18-65, 2. Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) 3. Currently receiving methadone or buprenorphine treatment for OUD and considered to be stable on current dose for at least 30 days 4. Willingness to engage with study protocol 5. Use of birth control (as appropriate)
Exclusion criteria
1. Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO 2. Pregnant or breastfeeding 3. Current use of benzodiazepines, tranquilizers, or other schedule IV sleep medications 4. Moderate or severe substance use disorder other than opioid or stimulant use disorder 5. SUVO consumption in the last 30 days 6. Use of medications that are contraindicated with the study 7. Past 30-day suicidal behavior 8. Use of continuous positive airway pressure (CPAP) device for sleep apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use: Proportion of Positive Urine Drug Screens (UDS) | Up to 30 days post-randomization | Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no) |
| Cocaine Use: Proportion of Positive UDS Screens | Up to 30 days post-randomization | Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Craving Visual Analog Scale (VAS) Regression Slope | Up to 30 days post-randomization | Regression slope of opioid craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving. |
| Insomnia Severity Regression Slope | Up to 30 days post-randomization | Regression slope of Insomnia Severity Index (ISI) scores over scheduled study visits through 30 days post-randomization. Total score range between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). Higher score worse insomnia. |
| Perceived Stress Scale Regression Slope | Up to 30 days post-randomization | Regression slope of Perceived Stress Scale (PSS) scores over scheduled study visits through 30 days post-randomization. Total score range 0 to 40, with higher scores indicating worse perceived stress. |
| Cocaine Craving Visual Analog Scale (VAS) Regression Slope | Up to 30 days post-randomization | Regression slope of cocaine craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving. |
| Total Sleep Time (TST) Regression Slope | Up to 30 days post-randomization | Regression slope of TST scores over scheduled study visits up to 30 days post-randomization. |
Countries
United States
Participant flow
Pre-assignment details
A total of 41 individuals attended a screening visit. Of the 20 individuals enrolled (i.e., initially determined as eligible to be scheduled for randomization), 5 declined enrollment and 2 no longer met criteria at the randomization visit and were not randomized. A total of 13 individuals were randomized. 12 of these individuals completed the study, one individual did not complete.
Participants by arm
| Arm | Count |
|---|---|
| Suvorexant 20mg Suvorexant | 6 |
| Placebo Placebo oral capsules | 7 |
| Total | 13 |
Baseline characteristics
| Characteristic | Total | Suvorexant | Placebo |
|---|---|---|---|
| Age, Continuous | 46.62 years STANDARD_DEVIATION 9.39 | 43.67 years STANDARD_DEVIATION 9.54 | 49.14 years STANDARD_DEVIATION 9.19 |
| Cocaine Craving VAS, | 44.92 units on a scale STANDARD_DEVIATION 28.09 | 44.27 units on a scale STANDARD_DEVIATION 28.16 | 45.49 units on a scale STANDARD_DEVIATION 30.28 |
| Insomnia Severity Index (ISI) | 13.84 score on a scale STANDARD_DEVIATION 8.25 | 15.67 score on a scale STANDARD_DEVIATION 6.71 | 12.29 score on a scale STANDARD_DEVIATION 9.62 |
| Opioid Craving Visual Analog Scale (VAS) | 36.38 units on a scale STANDARD_DEVIATION 28.85 | 39.43 units on a scale STANDARD_DEVIATION 23.9 | 33.77 units on a scale STANDARD_DEVIATION 34.22 |
| Perceived Stress Scale | 19 units on a scale STANDARD_DEVIATION 10.07 | 18.83 units on a scale STANDARD_DEVIATION 10.34 | 19.14 units on a scale STANDARD_DEVIATION 10.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 2 Participants |
| Total Sleep Time (TST) | 389.09 minutes STANDARD_DEVIATION 107.93 | 394 minutes STANDARD_DEVIATION 104.31 | 385 minutes STANDARD_DEVIATION 120.62 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 6 / 6 | 5 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
Primary
Cocaine Use: Proportion of Positive UDS Screens
Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization.
Time frame: Up to 30 days post-randomization
Population: One participant in the placebo group discontinued following randomization and did not have data collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant | Cocaine Use: Proportion of Positive UDS Screens | 0.83 Proportion of urine drug screens | Standard Deviation 0.41 |
| Placebo | Cocaine Use: Proportion of Positive UDS Screens | 0.97 Proportion of urine drug screens | Standard Deviation 0.07 |
Primary
Opioid Use: Proportion of Positive Urine Drug Screens (UDS)
Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no)
Time frame: Up to 30 days post-randomization
Population: One participant in the placebo group discontinued following randomization and did not have data collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant | Opioid Use: Proportion of Positive Urine Drug Screens (UDS) | 0.83 Proportion of urine drug screens | Standard Deviation 0.41 |
| Placebo | Opioid Use: Proportion of Positive Urine Drug Screens (UDS) | 0.67 Proportion of urine drug screens | Standard Deviation 0.52 |
Secondary
Cocaine Craving Visual Analog Scale (VAS) Regression Slope
Regression slope of cocaine craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving.
Time frame: Up to 30 days post-randomization
Population: One participant in the placebo group discontinued following randomization and did not have data collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Suvorexant | Cocaine Craving Visual Analog Scale (VAS) Regression Slope | -0.60 score on a scale/day |
| Placebo | Cocaine Craving Visual Analog Scale (VAS) Regression Slope | -0.71 score on a scale/day |
Secondary
Insomnia Severity Regression Slope
Regression slope of Insomnia Severity Index (ISI) scores over scheduled study visits through 30 days post-randomization. Total score range between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). Higher score worse insomnia.
Time frame: Up to 30 days post-randomization
Population: One participant in the placebo group discontinued following randomization and did not have data collected, leaving six participants in each group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Suvorexant | Insomnia Severity Regression Slope | -0.55 score on a scale/day |
| Placebo | Insomnia Severity Regression Slope | -0.16 score on a scale/day |
Secondary
Opioid Craving Visual Analog Scale (VAS) Regression Slope
Regression slope of opioid craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving.
Time frame: Up to 30 days post-randomization
Population: One participant in the placebo group discontinued following randomization and did not have data collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Suvorexant | Opioid Craving Visual Analog Scale (VAS) Regression Slope | -1.76 score on a scale/day |
| Placebo | Opioid Craving Visual Analog Scale (VAS) Regression Slope | -1.46 score on a scale/day |
Secondary
Perceived Stress Scale Regression Slope
Regression slope of Perceived Stress Scale (PSS) scores over scheduled study visits through 30 days post-randomization. Total score range 0 to 40, with higher scores indicating worse perceived stress.
Time frame: Up to 30 days post-randomization
Population: One participant in the placebo group discontinued following randomization and did not have data collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Suvorexant | Perceived Stress Scale Regression Slope | -0.19 score on a scale/day |
| Placebo | Perceived Stress Scale Regression Slope | 0.19 score on a scale/day |
Secondary
Total Sleep Time (TST) Regression Slope
Regression slope of TST scores over scheduled study visits up to 30 days post-randomization.
Time frame: Up to 30 days post-randomization
Population: Two participants did not have baseline data on TST and could not be included in the analysis. One additional participant in the placebo group discontinued following randomization and did not have data collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Suvorexant | Total Sleep Time (TST) Regression Slope | 11.68 score on a scale/day |
| Placebo | Total Sleep Time (TST) Regression Slope | 9.37 score on a scale/day |