Zolmitriptan for Cocaine Use Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Kentucky, Lexington, KY
Cocaine Use Disorders
Zolmitriptan - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug that activates a brain receptor called the 5-HT1b receptor can reduce the abuse-related effects of cocaine in people with cocaine use disorder.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cocaine Use Disorders

Study Objectives

This trial is evaluating whether Zolmitriptan will improve 4 primary outcomes and 11 secondary outcomes in patients with Cocaine Use Disorders. Measurement will happen over the course of Following at least 3 days of maintenance on placebo during inpatient admission.

Month 1
Adjective Rating Scale-Sedative
Adjective Rating Scale-Stimulant
Delay Discounting Task
Drug Effect Questionnaire
Stop-Signal Task Inhibitory Failures
Stop-Signal Task Reaction Time
n-back Task
Month 1
Side Effects
Temperature
Month 1
Blood pressure
Daily over approximately four week inpatient admissions
Heart rate
Day 3
Reinforcing Effects of Cocaine Following Placebo Maintenance.
Day 3
Reinforcing Effects of Cocaine Following Zolmitriptan Dose 1 Maintenance.
Day 3
Reinforcing Effects of Cocaine Following Zolmitriptan Dose 2 Maintenance.
Day 3
Reinforcing Effects of Cocaine Following Zolmitriptan Dose 3 Maintenance.

Trial Safety

Safety Progress

1 of 3

Other trials for Cocaine Use Disorders

Trial Design

4 Treatment Groups

Zolmitriptan Dose 3
1 of 4
Zolmitriptan Dose 1
1 of 4
Zolmitriptan Dose 2
1 of 4
Placebo
1 of 4
Experimental Treatment
Non-Treatment Group

This trial requires 20 total participants across 4 different treatment groups

This trial involves 4 different treatments. Zolmitriptan is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Zolmitriptan Dose 3Subjects 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.
Zolmitriptan Dose 1
Drug
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.
Zolmitriptan Dose 2Subjects 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.
PlaceboSubjects 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
FDA approved
Cocaine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 times over approximately 1 month inpatient admission
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 times over approximately 1 month inpatient admission for reporting.

Closest Location

University of Kentucky - Lexington, KY

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Recent cocaine use

Patient Q&A Section

What is cocaine use disorders?

"Cocaine use disorders are characterized by impaired decision making, poor social control and poor adjustment. Furthermore, co-occurrence of cocaine use disorders with other mental disorders like PTSD has been observed at varying degrees throughout the studies. The co-occurrence of ADHD and cocaine use disorders is relatively more frequent, due to co-administration of psychostimulants." - Anonymous Online Contributor

Unverified Answer

How many people get cocaine use disorders a year in the United States?

"Drug use disorder prevalence in the United States is significantly increasing. In particular, there is a persistent need for more efficient prevention and treatment of drug use disorders." - Anonymous Online Contributor

Unverified Answer

What causes cocaine use disorders?

"Substance use disorders can include other mental health disorders as well, or comorbid cocaine use plus mental health disorders, or comorbid alcohol use disorder with a comorbid mental health disorder. Substance use disorders may cause the underlying mental disorders. Substance abuse treatment can address co-occurring psychiatric disorders and substance use disorders." - Anonymous Online Contributor

Unverified Answer

What are the signs of cocaine use disorders?

"Cocaine use in adolescence was strongly associated with cocaine use and subsequent dependence. This was in part explained by early mood symptoms that increase the likelihood of cocaine use. Although the symptoms of cocaine use were nonspecific, screening people using cocaine use and its risks warrants further study." - Anonymous Online Contributor

Unverified Answer

Can cocaine use disorders be cured?

"Cocaine use disorder patients tend to have less severe problems, earlier onset, lesser prevalence of co-occurring SUDs on other drugs, and fewer co-occurring SUDs other than those on other drugs such as alcohol. Results from a recent paper may be related to the lesser severity of Cocaine use Disorder." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cocaine use disorders?

"This review emphasizes that treatment response to various psychoactive substances depends greatly on the individual. Therefore, any treatment can be beneficial to the patient. The most effective treatment for cocaine use disorders is dependent on the patient's exact psychiatric, biological, and psychological profiles. The goal of therapy is to identify the patient's needs and develop a treatment plan to address these needs as well as optimize long-term recovery and outcomes." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving zolmitriptan?

"There were no previous randomised controlled trials, and the studies reported in the literature were not tailored to the population studied. Zolmitriptan was a novel drug with no clinical experience, and the data gathered is of limited quality and relevance to clinical practice." - Anonymous Online Contributor

Unverified Answer

Does zolmitriptan improve quality of life for those with cocaine use disorders?

"Zolmitriptan significantly improves quality of life as measured by a validated HRQOL instrument after just one single outpatient session of treatment. This drug also appears to reduce cocaine consumption in cocaine users compared to an active placebo (p < 0.05). In addition, our data suggest that zolmitriptan may be an effective therapy for the treatment of cocaine users' HRQOL." - Anonymous Online Contributor

Unverified Answer

How serious can cocaine use disorders be?

"Current estimates of cocaine use disorder prevalence are low because only one of the six criteria is fulfilled by an appreciative subset of users. Estimates range from 5 to 20% depending on the severity of the definition employed to diagnose CUD." - Anonymous Online Contributor

Unverified Answer

How does zolmitriptan work?

"Zolmitriptan has a fast onset of action with peak effects in one hour, which allows rapid and effective dosing. The rapid onset also prevents the high peak concentration from leading to adverse effects. The rapid onset and duration of action make zolmitriptan ideal for the treatment of migraine attacks, especially for those with acute migraine attacks and migraine with aura." - Anonymous Online Contributor

Unverified Answer

What does zolmitriptan usually treat?

"Zolmitriptan is not a useful agent in managing the symptoms of narcolepsy, and it is not a useful agent in restoring normal sleep, and should not be recommended as a therapy for managing the narcolepsia. Zolmitriptan's use in narcolepsy is also contraindicated, because of its triggering effect on sleep. Zolmitriptan may be prescribed for the acute treatment of migraine with or without aura, and for the management of vascular headaches; however, patients may experience adverse effects when taken for long periods. Zolmitriptan may also be prescribed in low dosages under specific conditions for some patients, but these situations are rare." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cocaine use disorders?

"There was an increase in alcohol abuse from 1984 to 2011 in the United States. However, a significant increase in reported cocaine use occurred after 2000. From 1985 to 1996, the cocaine use disorder had become well-established in the United States, as over 100,000 individuals were being treated annually. From 1998 to 2012, cocaine use disorder in the United States increased from approximately 100,000 to 539,500 individuals being treated for the disorder. The increase in cocaine use disorder was not reflected by an increase in reported use of cocaine, indicating that cocaine use disorder had a substantial impact on cocaine use for many, and probably most, individuals." - 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.
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