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Stimulant

d-Amphetamine for Cocaine Use Disorder

Phase < 1
Recruiting
Led By Joshua Lile, PhD
Research Sponsored by Joshua A. Lile, Ph.D.
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 choices occur across a 40 minute session
Awards & highlights

Study Summary

This trial is testing a way to see how effective certain behavioral and pharmacological interventions are at reducing cocaine use.

Who is the study for?
This trial is for individuals who have recently used cocaine but are generally healthy. They should not have any serious physical or psychiatric diseases, and their lab results must be within normal ranges to participate.Check my eligibility
What is being tested?
The study is testing whether sustained release d-amphetamine, a medication, can influence the choice between taking cocaine or receiving money. Participants' decisions will be studied using tasks, computer modeling, and brain imaging (fMRI).See study design
What are the potential side effects?
While specific side effects are not listed here, sustained release d-amphetamine can typically cause jitteriness, trouble sleeping, decreased appetite, and mood changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~choices occur across a 40 minute session
This trial's timeline: 3 weeks for screening, Varies for treatment, and choices occur across a 40 minute session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TreatmentExperimental Treatment2 Interventions
Cocaine choice during d-amphetamine maintenance
Group II: Placebo TreatmentPlacebo Group2 Interventions
Cocaine choice during placebo maintenance

Find a Location

Who is running the clinical trial?

Joshua A. Lile, Ph.D.Lead Sponsor
5 Previous Clinical Trials
106 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,455 Previous Clinical Trials
2,596,946 Total Patients Enrolled
Joshua Lile, PhDPrincipal InvestigatorUniversity of Kentucky

Media Library

Sustained Release d-amphetamine (Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT04296006 — Phase < 1
Cocaine Use Disorder Research Study Groups: Placebo Treatment, Active Treatment
Cocaine Use Disorder Clinical Trial 2023: Sustained Release d-amphetamine Highlights & Side Effects. Trial Name: NCT04296006 — Phase < 1
Sustained Release d-amphetamine (Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04296006 — Phase < 1

Frequently Asked Questions

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

Is there an opportunity for recruitment currently available with this experiment?

"According to official records posted on clinicaltrials.gov, this research project is presently enrolling participants. The study was introduced on 15 January 2021 and most recently updated 11 March 2022."

Answered by AI

Is there an opportunity to participate in this clinical examination?

"The team is seeking 18 volunteers, aged between 18 and 55 years old who have a diagnosis of cocaine use disorder. The ideal candidates would also be in otherwise good health and recently used the substance."

Answered by AI

How many participants are partaking in this experimental research?

"Affirmative. Clinicaltrials.gov documents indicate that this clinical trial, which was initially posted on January 15th 2021, is actively searching for participants. 18 subjects need to be enlisted from one site in total."

Answered by AI

Are there precedents for trials involving Sustained Release d-amphetamine?

"Currently, 8 medical studies are exploring the effects of Sustained Release d-amphetamine with 1 trial in its final stage. 11 healthcare facilities across the country host these trials and one such centre is located in Atlanta, Georgia."

Answered by AI

Is there an age ceiling for participation in this experiment?

"To be included in this medical trial, applicants must fall between 18-55 years old. Alternatively, there are two dedicated studies for minors and thirteen specialised trials targeting elderly individuals over the age of 65."

Answered by AI

Who else is applying?

What state do they live in?
California
Tennessee
Indiana
How old are they?
18 - 65
What site did they apply to?
Laboratory of Human Behavioral Pharmacology
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
~0 spots leftby Apr 2024