An Early Phase 1 interventional study of Suvorexant and Cocaine in Cocaine Use Disorder, sponsored by William Stoops. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by William Stoops · Early Phase 1, Interventional, and Basic science
The research proposed here will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for cocaine, as well as other cocaine-associated maladaptive behaviors in active cocaine users. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of cocaine in humans. As such the outcomes will contribute to our understanding of the clinical neurobiology of cocaine use disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on cocaine addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.
William Stoops is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Drug: Cocaine · Drug: Placebo oral capsule
Subjects will be maintained on oral suvorexant dose 1. Cocaine will be administered acutely during suvorexant dose 1 maintenance. Placebo will be administered acutely during suvorexant dose 1 maintenance.
Drug: Suvorexant · Drug: Cocaine
Subjects will be maintained on oral suvorexant dose 2. Cocaine will be administered acutely during suvorexant dose 2 maintenance. Placebo will be administered acutely during suvorexant dose 2 maintenance.
Drug: Suvorexant · Drug: Cocaine
Subjects will be maintained on oral suvorexant dose 3. Cocaine will be administered acutely during suvorexant dose 3 maintenance. Placebo will be administered acutely during suvorexant dose 3 maintenance.
Drug: Suvorexant · Drug: Cocaine
The pharmacodynamic effects of suvorexant maintenance will be determined.
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.
The pharmacodynamic effects of placebo will be determined.
Reinforcing Effects of Cocaine
Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money
Time frame: 12 times over approximately 1 month inpatient admission.
| Milestone | Subjects Included in Analysis |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
| Withdrew: Covid-19 pandemic | 1 |
Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money
| Number of Cocaine Choices | Dose Condition 1 | Dose Condition 2 | Dose Condition 3 | Dose Condition 4 | Dose Condition 5 | Dose Condition 6 | Dose Condition 7 | Dose Condition 8 | Dose Condition 9 | Dose Condition 10 | Dose Condition 11 | Dose Condition 12 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reinforcing Effects of Cocaine | 1.3 ± 3.5 | 5.0 ± 5.3 | 8.3 ± 3. | 0 ± 0 | 3.7 ± 8.4 | 8.4 ± 2.7 | 1.3 ± 3.5 | 8.1 ± 3.7 | 9.3 ± 1.9 | 0.4 ± 1.1 | 6.6 ± 4.7 | 8.7 ± 1.9 |
Collected over 32 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects Included in Analysis | 0/8 (0%) | 0/8 (0%) | 8/8 (100%) |
| Event | Subjects Included in Analysis |
|---|---|
| Elevated Blood PressureCardiac disorders | 2/8 |
| Hand SwellingSkin and subcutaneous tissue disorders | 2/8 |
| Elevated Heart RateCardiac disorders | 1/8 |
| EcchymosisSkin and subcutaneous tissue disorders | 1/8 |
| BruisingSkin and subcutaneous tissue disorders | 1/8 |
| Burning SensationSkin and subcutaneous tissue disorders | 1/8 |
| IV Needle InfiltrationSkin and subcutaneous tissue disorders | 1/8 |
| Shoulder PainMusculoskeletal and connective tissue disorders | 1/8 |
| Arm SorenessSkin and subcutaneous tissue disorders | 1/8 |
| Saline Taste from IV FlushGastrointestinal disorders | 1/8 |
| Age, Continuous(years) | Subjects Included in Analysis |
|---|---|
| Mean | 44.5 ± 5.1 |
| Sex: Female, Male(Participants) | Subjects Included in Analysis |
|---|---|
| Female | 4 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Subjects Included in Analysis |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Subjects Included in Analysis |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 2 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Subjects Included in Analysis |
|---|---|
| United States | 8 |
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Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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William Stoops