What side effects are associated with this type of intervention?

Common treatments for Cocaine Use Disorder, such as psychostimulants (e.g., bupropion, dexamphetamine, methylphenidate), are associated with side effects like anxiety, agitation, insomnia, increased heart rate, and potential for abuse. Zolmitriptan, a selective 5-HT1b agonist being studied for its potential use, may cause dizziness, paresthesia, and nausea.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Cocaine Use Disorder. Research has explored various pharmacological approaches, including selective 5-HT1b agonists like Zolmitriptan, which have shown promise in preclinical studies by attenuating cocaine-associated behaviors. However, these findings have not yet been translated into approved treatments for humans.

What other types of research exist?

Promising novel alternatives to Zolmitriptan for treating Cocaine Use Disorder include other selective 5-HT1b agonists that have shown efficacy in preclinical studies. However, specific names of these alternatives are not provided in the context. It is advisable to consult recent clinical trials and research publications for the latest developments in this area.

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Stimulant

Zolmitriptan for Cocaine Use Disorder

Q: What is the mechanism of action of this treatment?

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.

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

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

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 more

Secondary study objectives

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

~330

0 / 1Eligibility criteria met

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.