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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL150835 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo sleep medication (2 placebo oral capsules) |
|
| Suvorexant | Active Comparator | Sleep medication (20mg suvorexant; 2 10mg capsules; patients can self-titrate to 1 10mg capsule) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug | Dual orexin receptor antagonist |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time | Mean total number of minutes slept per night as measured by actigraphy and self-reported sleep diary. Mean total sleep time will be collected over a seven-night period in weeks 1, 4, and 8 of the trial. | 21 nights |
| Total Wake Time After Sleep Onset | Mean total number of minutes awake between initial sleep onset and final morning awakening, measured by actigraphy and self-reported sleep diary. Mean wake after sleep onset will be collected over a seven-night period in weeks 1, 4, and 8 of the trial. | 21 nights |
| Change in Perceived Stress Scale 4 (PSS-4) score | Mean daily scores on the PSS-4 (a four item scale self-reported scale than measures stress using a 0-4 Likert scale; total range of PSS-4 scores is 0-16; lower scores indicate lower daily stress relative to higher scores, which indicate higher daily stress). Mean PSS-4 scores will be collected over a seven-day period in weeks 1, 4, and 8 of the trial. | 21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial) |
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Inclusion Criteria:
Exclusion Criteria:
Self-reported male or female
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| Name | Affiliation | Role |
|---|---|---|
| Andrew S Huhn, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Man Alive Inc., Lane Treatment Center | Baltimore | Maryland | 21218 | United States | ||
| Addiction Treatment Services at Johns Hopkins Bayview Medical Center |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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| Drug |
Weight and color matched placebo |
|
| Baltimore |
| Maryland |
| 21224 |
| United States |
| Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| Ashley Addiction Treatment | Bel Air | Maryland | 21014 | United States |
| Ashley Addiction Treatment | Elkton | Maryland | 21921 | United States |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |