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Stimulant

Zolmitriptan for Cocaine Use Disorder

Phase < 1
Recruiting
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 12 times over approximately 1 month inpatient admission
Awards & highlights

Study Summary

This trial will test whether or not the drug zolmitriptan, which is used to treat migraines, can also help reduce the reinforcing and other abuse-related effects of cocaine in humans.

Who is the study for?
This trial is for individuals who have recently used cocaine and do not have a history of serious physical or psychiatric disorders. Participants must not have any health conditions that could interfere with the study, such as heart disease or seizures, and women must be using effective birth control.Check my eligibility
What is being tested?
The trial is testing Zolmitriptan, a migraine medication thought to reduce cocaine's addictive effects by targeting the brain's serotonin system. It compares how well Zolmitriptan works against a placebo when taken by people with Cocaine Use Disorder.See study design
What are the potential side effects?
Zolmitriptan may cause side effects like tingling sensations, drowsiness, nausea, dry mouth, and muscle weakness. Since it affects serotonin levels in the brain, there might also be mood-related side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 times over approximately 1 month inpatient admission
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 times over approximately 1 month 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
Reinforcing Effects of Cocaine Following Placebo Maintenance.
Reinforcing Effects of Cocaine Following Zolmitriptan Dose 1 Maintenance.
Reinforcing Effects of Cocaine Following Zolmitriptan Dose 2 Maintenance.
+1 more
Secondary outcome measures
Adjective Rating Scale-Sedative
Adjective Rating Scale-Stimulant
Blood pressure
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Zolmitriptan Dose 3Experimental Treatment2 Interventions
Subjects will be maintained on oral zolmitriptan dose 3. Cocaine will be administered acutely during zolmitriptan dose 3 maintenance. Placebo will be administered acutely during zolmitriptan dose 3 maintenance.
Group II: Zolmitriptan Dose 2Experimental Treatment2 Interventions
Subjects will be maintained on oral zolmitriptan dose 2. Cocaine will be administered acutely during zolmitriptan dose 2 maintenance. Placebo will be administered acutely during zolmitriptan dose 2 maintenance.
Group III: Zolmitriptan Dose 1Experimental Treatment1 Intervention
Subjects will be maintained on oral zolmitriptan dose 1. Cocaine will be administered acutely during zolmitriptan dose 1 maintenance. Placebo will be administered acutely during zolmitriptan dose 1 maintenance.
Group IV: PlaceboPlacebo Group2 Interventions
Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zolmitriptan
2016
Completed Phase 4
~4220
Cocaine
2018
Completed Phase 4
~320

Find a Location

Who is running the clinical trial?

William StoopsLead Sponsor
8 Previous Clinical Trials
257 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,389 Total Patients Enrolled

Media Library

Cocaine (Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT05019430 — Phase < 1
Cocaine Use Disorder Research Study Groups: Placebo, Zolmitriptan Dose 1, Zolmitriptan Dose 3, Zolmitriptan Dose 2
Cocaine Use Disorder Clinical Trial 2023: Cocaine Highlights & Side Effects. Trial Name: NCT05019430 — Phase < 1
Cocaine (Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05019430 — Phase < 1

Frequently Asked Questions

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

Are elderly individuals being considered for participation in this clinical investigation?

"The minimum age for enrolment in this clinical trial is 18, while the upper limit of participation has been set at 55."

Answered by AI

What are the main aims of this trial?

"The main aim of this trial is to measure the reinforcing effects of cocaine following zolmitriptan dose 3 maintenance. As secondary objectives, participants will complete a Drug Effect Questionnaire (total scores=0-100; Higher scores=greater drug effect), a Side Effects questionnaire and a Delay Discounting Task for which responses will be used to calculate discounting slope (i.e., K). These assessments shall take place over at least three days while the patient stays admitted on our inpatient unit.."

Answered by AI

To what condition is Zolmitriptan commonly administered?

"Zolmitriptan is an effective therapeutic agent for handling local anaesthesia, moderate to severe hepatic impairments, and the management of migraine disorders."

Answered by AI

Do I qualify to participate in this research trial?

"The prerequisites for this trial are an age range of 18 to 55 and a diagnosis of cocaine use disorder. This project is looking to sign up 20 participants in total."

Answered by AI

What is the maximum capacity for people involved in this research endeavor?

"Affirmative. According to information hosted on clinicaltrials.gov, this trial was first posted in October of 2021 and is currently seeking participants. This research initiative is looking for 20 people from a single site."

Answered by AI

Are there any earlier research projects that utilized Zolmitriptan?

"Currently, 2 studies are exploring the effects of Zolmitriptan. Neither is in its final stage (Phase 3). The trials for this medication are being conducted in New Haven, Connecticut and at two other sites."

Answered by AI

Can additional participants still be enrolled in this research project?

"Affirmative. According to clinicaltrials.gov, the original posting of this study was made on October 15th 2021 and it has since been revised June 3rd 2022. The research team is currently seeking 20 volunteers across one trial site."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Cocaine and Zolmitriptan
William Stoops 2021. "Cocaine and Zolmitriptan". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05019430.
~2 spots leftby Jul 2024
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