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NCT05630781 · ClinicalTrials.gov registry record · NA
Orexin s Role in the Neurobiology of Substance Use Disorder
A NA study of Nicotine Dependence, sponsored by National Institute on Drug Abuse (NIDA).
- Recruiting
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT05630781 is a NA study of Nicotine Dependence that is actively recruiting participants, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 140 participants, below the 185-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (24% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05630781, a NA study of Nicotine Dependence, is actively recruiting participants, sponsored by National Institute on Drug Abuse (NIDA).
- RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
Study Description: Despite the availability of pharmacotherapy for some substance use disorders, relapse vulnerability is still a significant issue. This suggests medications with alternative mechanisms of action should be explored to address this unmet need. Substantial preclinical research indicates that orexin antagonism blunts the internally and externally triggered motivation to attain abused substances. This research project will translate these preclinical findings into the clinical domain by administering the FDA approved orexin antagonist, suvorexant, to those with a substance use disorder. Suvorexant s ability to blunt neurobiological correlates of substance misuse will be assessed. This will be assessed following acute and repeated drug administration. Baseline individual differences will be considered to determine whether neurobiological variance influences suvorexant s impact in those with nicotine dependence. In an independent arm, the interaction between suvorexant and a dopamine agonist (methylphenidate) on cognitive function will be assessed in non-smoking individuals. Objectives: The objective is to determine the acute and chronic impact of the orexin antagonist, suvorexant, on neurobiological and behavioral factors linked with substance use disorders. Whether such effects are mediated by baseline characteristics will be tested. Given suvorexant is an FDA approved treatment for insomnia, sleep will be evaluated as well in the nicotine dependent arm. Endpoints: In nicotine-dependent individuals, suvorexant s impact on brain function will be assessed several ways by evaluating: 1) resting function, 2) reactivity to drug cues, 3) reactivity to non-drug related cognitive tasks. Sleep and nicotine use will be measured throughout the study period. In those without nicotine-dependence, the impact of suvorexant and the interaction of acute methylphenidate and suvorexant on brain function will be assessed. This arm will provide insight into how suvorex
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Methylphenidate
- DRUG Belsomra
Study Locations (1)
Maryland
- National Institute on Drug Abuse - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05630781
The ClinicalTrials.gov registry entry for NCT05630781 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 185-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (24% lower). The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Nicotine Dependence appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05630781 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05630781 about?
NCT05630781 is a clinical study titled "Orexin s Role in the Neurobiology of Substance Use Disorder". Study Description: Despite the availability of pharmacotherapy for some substance use disorders, relapse vulnerability is still a significant issue. This suggests medications with alternative mechanisms of action should be explored to address this unmet need. Substantial preclinical research indica...
What is the current status of trial NCT05630781?
This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2023-02-15. Estimated completion is 2027-12-31.
What conditions does trial NCT05630781 study?
This clinical trial studies the following conditions: Nicotine Dependence.
What interventions are being tested in trial NCT05630781?
The interventions under investigation include: Placebo (DRUG), Methylphenidate (DRUG), Belsomra (DRUG).
Who is sponsoring clinical trial NCT05630781?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05630781 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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