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NCT05610072: BED IN 43

Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine)

Recruiting now EARLY_PHASE1 Last updated 11 December 2025
What this trial tests

EARLY_PHASE1 trial testing n-acetylcysteine in Cocaine Use Disorder in 24 participants. Currently enrolling.

Timeline
15 December 2022
Primary endpoint
31 December 2026
31 December 2026

Quick facts

Lead sponsorWilliam Stoops
PhaseEARLY_PHASE1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposebasic science
Enrollment24
Start date15 December 2022
Primary completion31 December 2026
Estimated completion31 December 2026
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

William Stoops

Who can join

Adults 18 to 55, any sex, with Cocaine Use Disorder or Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overarching hypotheses of this protocol are that (1) persistent brain glutamate changes induced by chronic opioid use will exacerbate use of cocaine during opioid physical dependence and withdrawal and (2) n-acetylcysteine (NAC) will ameliorate glutamatergic dysregulation, and thus will reduce both opioid and cocaine demand. These hypotheses will be tested with two specific aims. Specific Aim 1. Determine the reinforcing effects of cocaine in individuals with comorbid opioid and cocaine use disorder with physiological dependence on opioids during NAC maintenance. All subjects will be maintained on oral hydromorphone. They will also be randomly assigned to receive placebo or oral NAC (2.4 g/day), stratified by sex. After dose stabilization, experimental sessions will be conducted in which subjects complete hypothetical cocaine purchase tasks during opioid maintenance and opioid withdrawal. The hypotheses are: 1) cocaine purchasing will be greater during opioid withdrawal and 2) NAC maintenance will attenuate cocaine purchasing across opioid maintenance and withdrawal periods. Specific Aim 2. Evaluate glutamate functionality during periods of opioid maintenance and withdrawal in individuals with comorbid opioid and cocaine use disorder and physiological dependence on opioids during NAC maintenance. Subjects will undergo magnetic resonance spectroscopy to evaluate brain glutamate changes as a function of opioid maintenance/withdrawal state and NAC maintenance. The hypotheses are: 1) glutamate levels will be elevated during opioid withdrawal and 2) NAC maintenance will ameliorate elevated glutamate levels.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of n-acetylcysteine

Trials testing the same drug.

Other recruiting trials for Cocaine Use Disorder

Currently open trials in the same condition.

Other William Stoops trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05610072.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing