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Suvorexant and Cocaine

NCT03937986 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-02-09

Study results available
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Summary

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.

Conditions

  • Cocaine Use Disorder

Interventions

DRUG

Suvorexant

The pharmacodynamic effects of suvorexant maintenance will be determined.

DRUG

Cocaine

The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.

DRUG

Placebo oral capsule

The pharmacodynamic effects of placebo will be determined.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • William Stoops

    lead OTHER

Principal Investigators

  • William W Stoops, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-11
Primary Completion
2022-04-30
Completion
2022-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03937986 on ClinicalTrials.gov