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Opioid Analgesic

Intravenous Challenge Drug: Hydromorphone for Opioid Use Disorder

Phase 2
Waitlist Available
Led By Sandra D Comer, PhD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-reported opioid use for nontherapeutic purposes on at least 21 days in the 30 days prior to screening, physical dependence on opioids, recent intravenous opioid use, and meeting DSM 5 criteria for moderate-severe opioid use disorder.
Demonstrate understanding how to complete the self-administration tasks and VAS Questionnaire.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (8-9 weeks)
Awards & highlights

Study Summary

This trial is testing the abuse potential of the drug oxymorphone in comparison to other opioids. It is designed to study the reinforcing effects of the drug among physically dependent opioid abusers.

Eligible Conditions
  • Opioid Use Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (8-9 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (8-9 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive Subjective Drug Effects (i.e., Drug "Liking").
Secondary outcome measures
Positive Subjective Effects

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Intravenous Challenge Drug: HydromorphoneActive Control1 Intervention
IV Dose Range: 3.2, 5.6, 10, 18 mg/70kg of the participant's body weight
Group II: Intravenous Challenge Drug: OxycodoneActive Control1 Intervention
IV Dose Range: 10, 18, 32, 56 mg/70kg of the participant's body weight
Group III: Intravenous Challenge Drug: OxymorphoneActive Control1 Intervention
Intravenous (IV) Dose Range: 1.8, 3.2, 5.6, 10 mg/70kg of the participant's body weight
Group IV: Intravenous Challenge Drug: PlaceboPlacebo Group1 Intervention
IV saline

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
474 Previous Clinical Trials
153,241 Total Patients Enrolled
University of KentuckyOTHER
184 Previous Clinical Trials
226,550 Total Patients Enrolled
Sandra D Comer, PhDPrincipal InvestigatorNew York State Psychiatric Institute / Columbia University Medical Center
7 Previous Clinical Trials
540 Total Patients Enrolled

Frequently Asked Questions

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

Are there still vacancies to enter this trial?

"Per the information on clinicaltrials.gov, this particular trial is no longer taking applicants; initial posting was done on March 15th 2018 and the most recent update occurred September 1st 2022. However, there are 291 other medical trials actively recruiting patients at present."

Answered by AI

Is there an age restriction for participation in this research trial?

"This clinical trial necessitates that all participants be between 21 and 55 years of age. There are 22 trials available for those below the legal age, while 240 studies cater to seniors beyond 65."

Answered by AI

Are there any particular participants who are ideal for this trial?

"This clinical trial is seeking 20 opioid addicts, aged between 21 and 55 years old. To be eligible for the study, patients must meet specific criteria including: capacity to comprehend and provide a digitally signed consent form; self-reported illicit use of opioids on at least 3 weeks in the month preceding screening; physical dependence on opioids; recent intravenous opioid consumption; meeting DSM 5 criteria for moderate-severe opioid abuse disorder; BMI ranging from 18 to 35 kg/m2 with weight over 50kg (110 lbs); general health as determined by an investigator; women able to prove they are not pregnant or breastfeeding during screening stage; willingness and capability of"

Answered by AI

What potential risks are associated with the administration of intravenous Morphine?

"With Phase 2 evidence providing a baseline of safety, our team at Power rated Intravenous Challege Drug: Morphine as a 2 on the 3-point scale. Clinical data does not yet provide indications that this medication is efficacious."

Answered by AI
~2 spots leftby Mar 2025