← Back to Search

Opioid Agonist

Medication Interactions for Opioid Use Disorder and Sedative Use

Phase 1
Waitlist Available
Led By Sharon L Walsh, Ph.D.
Research Sponsored by Sharon Walsh
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 these outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Awards & highlights

Study Summary

This trial will study the effects of opioids and sedatives, alone and in combination, on people's ratings of drug liking and other abuse-related effects, as well as on physiological outcomes.

Eligible Conditions
  • Opioid Use Disorder
  • Sedative Use

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~these outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
This trial's timeline: 3 weeks for screening, Varies for treatment, and these outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Subject-Rated Outcomes
Secondary outcome measures
Change in Blood pressure
Change in Oxygen Saturation
Change in Respiration Rate

Side effects data

From 2020 Phase 4 trial • 133 Patients • NCT03075501
6%
Dry mouth
2%
Shakiness/Trembling
2%
Heart racing
1%
High heart rate and blood pressure
100%
80%
60%
40%
20%
0%
Study treatment Arm
20mg Methamphetamine
0mg Methamphetamine (Placebo)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Oral sedativeExperimental Treatment1 Intervention
Participants will receive non-therapeutic experimental doses of active or placebo oral sedative. Active sedative/placebo will be administered once per session and will be administered orally.
Group II: Oral opioid agonistExperimental Treatment1 Intervention
Participants will receive non-therapeutic experimental doses of active or placebo oral opioid agonist. Active opioid agonist/placebo will be administered once per session and will be administered orally.
Group III: Opioid agonist/sedativeExperimental Treatment2 Interventions
Participants will receive non-therapeutic, experimental doses of active opioid agonist/placebo in combination with non-therapeutic, experimental doses of active sedative/placebo. Opioid/placebo and sedative/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid and sedative doses will be administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Opioid Agonist
2019
Completed Phase 1
~40
Sedatives
2019
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,467 Previous Clinical Trials
2,619,095 Total Patients Enrolled
Sharon WalshLead Sponsor
3 Previous Clinical Trials
131 Total Patients Enrolled
Sharon L Walsh, Ph.D.Principal InvestigatorUniversity of Kentucky
2 Previous Clinical Trials
59 Total Patients Enrolled

Media Library

Opioid Agonist (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04315181 — Phase 1
Opioid Use Disorder Research Study Groups: Oral sedative, Oral opioid agonist, Opioid agonist/sedative
Opioid Use Disorder Clinical Trial 2023: Opioid Agonist Highlights & Side Effects. Trial Name: NCT04315181 — Phase 1
Opioid Agonist (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04315181 — Phase 1

Frequently Asked Questions

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

Is the minimum age for participation in this medical research set at 18 or below?

"This trial only accepts patients 18 to 55 years old. For minors and seniors, there are 14 trials available for the former cohort and 120 studies open to those above 65 years of age."

Answered by AI

What is the maximum capacity at which this clinical trial can be conducted?

"Correct. Clinicaltrials.gov documents that this research is actively enrolling participants, with the original post date being March 25th 2019 and a recent edit on November 17th 2022. 72 volunteers are needed at one location for the clinical trial to be successful."

Answered by AI

Are there opportunities for enrolment in this research project currently?

"Affirmative. Per the information found on clinicaltrials.gov, this medical trial is currently enrolling participants which were initially posted back in March of 2019 and was last updated on November 17th 2022. 72 patients are needed to be recruited from 1 site."

Answered by AI

Would I be qualified to join this clinical trial?

"This observational research is recruiting 72 individuals aged 18 to 55, and the requisite criteria for enrollment involves past or present non-medicinal consumption of opioids and sedative medications."

Answered by AI

To what extent are sedatives deemed safe for human consumption?

"Although limited data on the efficacy and safety of sedatives is available, our team at Power assigned a score of 1 to this phase 1 trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prescription Medication Interactions
Sharon Walsh 2019. "Prescription Medication Interactions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04315181.
~5 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top