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NCT05019430 · ClinicalTrials.gov registry record · Early Phase 1
Cocaine and Zolmitriptan
A Early Phase 1 study, sponsored by William Stoops.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT05019430 is a Early Phase 1 study that has completed, run by William Stoops. The registered enrollment target is 12 participants.
The verdict
NCT05019430, a Early Phase 1 study, has completed, sponsored by William Stoops.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Cocaine potently inhibits the reuptake of serotonin (5-HT). Increased synaptic 5-HT resulting from this reuptake inhibition activates multiple 5-HT receptor subtypes. Some of these receptor subtypes have been implicated in the abuse-related effects of cocaine, including its primary reinforcing effects (i.e., cocaine taking behavior). 5-HT1b receptors, which are autoreceptors on 5-HT nerve endings that regulate 5-HT release and heteroreceptors that also mediate other neurotransmitter release, play a particularly important role in cocaine effects, likely because they are highly expressed in the mesocorticolimbic system. The 5-HT1b system displays profound dysregulation during both active cocaine use and abstinence. Initial preclinical research showed that selective 5-HT1b agonists enhanced the reinforcing and locomotor effects of cocaine during ongoing cocaine administration, but subsequent research showed that these agents robustly attenuated reinstatement of cocaine- and cue-primed cocaine seeking behavior. These findings have been replicated in rigorously conducted studies using multiple schedules of reinforcement and negative sucrose reinforcement controls across laboratories. Notably, though, these preclinical studies used compounds not approved for use in humans, hindering translation. Recently published data show that zolmitriptan, a commercially available selective 5-HT1b agonist migraine medication, also selectively attenuates the reinforcing and other abuse-related effects of cocaine, regardless of stage of use (i.e., ongoing or extinguished cocaine self-administration). Although a robust preclinical literature supports the premise that 5-HT1b activation reduces a number of cocaine-associated behaviors (e.g., self-administration, cocaine seeking), this area remains unstudied in humans. The overarching goal of this project is to advance these promising preclinical findings, specifically those with zolmitriptan, to a clinical population, thereby demonstrating
Interventions
- DRUG Placebo oral capsule
- DRUG Cocaine
- DRUG Zolmitriptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-10-15 |
| Est. Completion | 2025-01-09 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05019430
The ClinicalTrials.gov registry entry for NCT05019430 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is William Stoops, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo oral capsule is the first listed.
NCT05019430 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05019430 about?
NCT05019430 is a clinical study titled "Cocaine and Zolmitriptan". Cocaine potently inhibits the reuptake of serotonin (5-HT). Increased synaptic 5-HT resulting from this reuptake inhibition activates multiple 5-HT receptor subtypes. Some of these receptor subtypes have been implicated in the abuse-related effects of cocaine, including its primary reinforcing effec...
What is the current status of trial NCT05019430?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2021-10-15. Estimated completion is 2025-01-09.
What interventions are being tested in trial NCT05019430?
The interventions under investigation include: Placebo oral capsule (DRUG), Cocaine (DRUG), Zolmitriptan (DRUG).
Who is sponsoring clinical trial NCT05019430?
This trial is sponsored by William Stoops, which has 13 total clinical trials registered on ClinicalTrials.gov.
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