Sedatives for Opioid Use Disorder

Center on Drug and Alcohol Research, Lexington, KY
Opioid Use Disorder+1 More ConditionsSedatives - Drug
Eligibility
18 - 55
All Sexes

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 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).

Hour 8
Change in Blood pressure
Hour 8
Change in Oxygen Saturation
Hour 8
Change in Respiration Rate
Hour 8
Change in Subject-Rated Outcomes

Trial Safety

Phase-Based Safety

1 of 3

Side Effects for

20mg Methamphetamine
6%Dry mouth
2%Shakiness/Trembling
2%Heart racing
1%High heart rate and blood pressure
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03075501) in the 20mg Methamphetamine ARM group. Side effects include: Dry mouth with 6%, Shakiness/Trembling with 2%, Heart racing with 2%, High heart rate and blood pressure with 1%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Oral sedative
1 of 3
Oral opioid agonist
1 of 3
Opioid agonist/sedative
1 of 3

Experimental Treatment

72 Total Participants · 3 Treatment Groups

Primary Treatment: Sedatives · No Placebo Group · Phase 1

Oral sedative
Drug
Experimental Group · 1 Intervention: Sedatives · Intervention Types: Drug
Oral opioid agonist
Drug
Experimental Group · 1 Intervention: Opioid Agonist · Intervention Types: Drug
Opioid agonist/sedativeExperimental Group · 2 Interventions: Opioid Agonist, Sedatives · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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).

Who is running the clinical trial?

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

Eligibility Criteria

Age 18 - 55 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently using opioids or sedatives for non-medical reasons.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.