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n-Acetylcysteine for Substance Use Disorder (BED IN 43 Trial)

Phase < 1
Recruiting
Led By William W Stoops
Research Sponsored by William Stoops
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily during approximately 10 day inpatient admission
Awards & highlights

BED IN 43 Trial Summary

This trial will test if NAC can reduce opioid and cocaine demand in people with opioid and cocaine use disorder.

Who is the study for?
This trial is for adults aged 18-55 with both opioid and cocaine use disorders who are not seeking treatment. They must be physically dependent on opioids, have normal lab results, no MRI contraindications, and be in good health otherwise. Women must use effective birth control.Check my eligibility
What is being tested?
The study tests if n-acetylcysteine (NAC) can reduce the desire for cocaine during opioid dependence and withdrawal by balancing brain glutamate levels. Participants will take oral hydromorphone with either NAC or placebo and undergo tasks and MRIs to assess changes.See study design
What are the potential side effects?
Possible side effects include allergic reactions to NAC or hydromorphone, gastrointestinal issues like nausea or vomiting, headache, dizziness, skin rash, increased risk of bleeding for those on anticoagulants due to NAC.

BED IN 43 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily during approximately 10 day inpatient admission
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily during approximately 10 day inpatient admission for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gamma-aminobutyric acid
Glutamate function
Hypothetical cocaine purchasing
+1 more
Secondary outcome measures
Clinical opioid withdrawal
Craving
Subjective opioid withdrawal
Other outcome measures
Diastolic blood pressure
Heart rate
Oxygen Saturation
+4 more

BED IN 43 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: n-AcetylcysteineExperimental Treatment3 Interventions
Subjects will receive 0.6 g oral n-acetylcysteine 4 times per day.
Group II: PlaceboPlacebo Group3 Interventions
Subjects will receive oral placebo 4 times per day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
n-acetylcysteine
2006
Completed Phase 4
~250
Hydromorphone
2005
Completed Phase 4
~4340

Find a Location

Who is running the clinical trial?

William StoopsLead Sponsor
8 Previous Clinical Trials
253 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,619,324 Total Patients Enrolled
William W StoopsPrincipal InvestigatorUniversity of Kentucky

Media Library

Hydromorphone Clinical Trial Eligibility Overview. Trial Name: NCT05610072 — Phase < 1
Opioid Use Disorder Research Study Groups: n-Acetylcysteine, Placebo
Opioid Use Disorder Clinical Trial 2023: Hydromorphone Highlights & Side Effects. Trial Name: NCT05610072 — Phase < 1
Hydromorphone 2023 Treatment Timeline for Medical Study. Trial Name: NCT05610072 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program open to individuals under the age of 65?

"This trial's inclusion criteria necessitates that patients must be between 18 to 55 years old. There are 263 trials involving minors and 806 studies for seniors."

Answered by AI

Is there still opportunity for individuals to participate in this experiment?

"According to the clinicaltrials.gov database, this trial is not currently recruiting patients and has been inactive since November 8th 2022. Despite this, there are still a sizable 1,157 other medical studies that participants may join at present time."

Answered by AI

What criteria must an individual meet to be eligible for enrollment in this clinical trial?

"Patients with cocaine use disorders aged between 18 and 55 years may be eligible to join this study, which has an enrolment cap of 24 individuals."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine)
William Stoops 2022. "Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05610072.
~16 spots leftby Dec 2026
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