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NCT05610072: BED IN 43
Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine)
EARLY_PHASE1 trial testing n-acetylcysteine in Cocaine Use Disorder in 24 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | William Stoops |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 15 December 2022 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- n-acetylcysteine — full drug profile →
- Hydromorphone (HYDROMORPHONE) — full drug profile →
- Placebo n-acetylcystine
- Placebo hydromorphone
Conditions studied
- Cocaine Use Disorder — all drugs for Cocaine Use Disorder →
- Opioid Use Disorder — all drugs for Opioid Use Disorder →
- Stimulant Use Disorder — all drugs for Stimulant Use Disorder →
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.
Verify or expand the search:
- PubMed search for NCT05610072
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of n-acetylcysteine
Trials testing the same drug.
- NCT05903014 — Effectiveness of N-Acetylcysteine (NAC) in Motivational Enhancement Therapy for Nicotine Addiction · Phase 4 · completed
Other recruiting trials for Cocaine Use Disorder
Currently open trials in the same condition.
- NCT07227948 — Repurposing Semaglutide for the Treatment of Cocaine Use Disorder · Phase 2 · recruiting
- NCT07086794 — Cocaine and Pentoxifylline (BED IN 47) · EARLY_PHASE1 · recruiting
- NCT06050304 — CRACK-TARGET 1: Descriptive Study of Observed Behavioral Sensitization and Expectations · NA · recruiting
- NCT07091877 — Cocaine Cue-reactivity Incubation Study · NA · recruiting
- NCT05986578 — Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder · NA · recruiting
Other William Stoops trials
Trials by the same sponsor.
- NCT07226596 — Non-Abstinence Outcomes in Methamphetamine Use Disorder · NA · recruiting
- NCT07086794 — Cocaine and Pentoxifylline (BED IN 47) · EARLY_PHASE1 · recruiting
- NCT06989853 — Methamphetamine and Troriluzole · EARLY_PHASE1 · recruiting
- NCT06326684 — Suvorexant and Alcohol · EARLY_PHASE1 · recruiting
- NCT05019430 — Cocaine and Zolmitriptan · EARLY_PHASE1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05610072 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by William Stoops
- Last refreshed: 11 December 2025
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.
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