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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
Must not have
Contraindications to cocaine or zolmitriptan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 times over approximately 1 month inpatient admission
Summary
This trial is testing zolmitriptan, a migraine medication, to see if it can help people who use cocaine. The medication works by affecting certain brain receptors to reduce the desire for cocaine. The goal is to find out if this treatment can be effective in humans as it has shown promise in animal studies. Zolmitriptan has been used successfully for treating migraines.
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot take cocaine or zolmitriptan due to health reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 times over approximately 1 month inpatient admission
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 times over approximately 1 month inpatient admission
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Adjective Rating Scale-Sedative
Adjective Rating Scale-Stimulant
Blood pressure
+8 moreTrial 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
~330
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Cocaine Use Disorder often target the serotonin (5-HT) system, particularly the 5-HT1b receptor. Cocaine increases synaptic serotonin by inhibiting its reuptake, which activates various 5-HT receptors involved in its reinforcing effects.
Selective 5-HT1b agonists, such as Zolmitriptan, have shown potential in reducing cocaine-seeking behaviors and self-administration in preclinical studies. This is significant for patients as it suggests that medications targeting the 5-HT1b receptor could help mitigate the reinforcing effects of cocaine, offering a promising approach to treatment.
Integrating treatments for methamphetamine abuse: a psychosocial perspective.
Integrating treatments for methamphetamine abuse: a psychosocial perspective.
Find a Location
Who is running the clinical trial?
William StoopsLead Sponsor
8 Previous Clinical Trials
228 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,595 Previous Clinical Trials
3,328,723 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious physical or mental health conditions that would interfere with the study.I cannot take cocaine or zolmitriptan due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Zolmitriptan Dose 1
- Group 3: Zolmitriptan Dose 3
- Group 4: Zolmitriptan Dose 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.