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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR PEMOLINE


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All Clinical Trials for PEMOLINE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000282 ↗ Pemoline for Cocaine Abuse - 7 Completed National Institute on Drug Abuse (NIDA) Phase 2 1994-09-01 The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.
NCT00000282 ↗ Pemoline for Cocaine Abuse - 7 Completed VA Connecticut Healthcare System Phase 2 1994-09-01 The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.
NCT00000282 ↗ Pemoline for Cocaine Abuse - 7 Completed Yale University Phase 2 1994-09-01 The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.
NCT00000340 ↗ Pemoline in the Treatment of Stimulant Dependence - 5 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 1996-06-01 The purpose of this study is to assess the efficacy of pemoline in treating cocaine and/or methamphetamine dependent adults with comorbid Adult Attention Deficit Hyperactivity Disorder (ADHD).
NCT00220506 ↗ Fatigue Treatment Using Provigil Unknown status Sheba Medical Center N/A 2005-09-01 To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients
NCT00538655 ↗ A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence Completed California Pacific Medical Center Research Institute Phase 2 2008-01-01 Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants such as the amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence. Specific Aims: 1. Determine the safety of modafinil in the treatment of methamphetamine dependence. 2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence. 3. Assess the effect of modafinil on cognitive function in methamphetamine users. 4. Assess the effect of modafinil on methamphetamine withdrawal symptoms. 5. Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring. Hypotheses: 1. Modafinil will be as safe and well tolerated as placebo in a comparison group from another study. 2. Subjects given modafinil will use less methamphetamine than subjects given placebo. 3. Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo. 4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo. 5. Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PEMOLINE

Condition Name

Condition Name for PEMOLINE
Intervention Trials
Cocaine-Related Disorders 2
All Multiple Sclerosis Patients 1
Fatigue 1
Methamphetamine Addiction 1
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Condition MeSH

Condition MeSH for PEMOLINE
Intervention Trials
Sclerosis 2
Multiple Sclerosis 2
Fatigue 2
Cocaine-Related Disorders 2
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Clinical Trial Locations for PEMOLINE

Trials by Country

Trials by Country for PEMOLINE
Location Trials
United States 2
Austria 1
Israel 1
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Trials by US State

Trials by US State for PEMOLINE
Location Trials
California 1
Connecticut 1
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Clinical Trial Progress for PEMOLINE

Clinical Trial Phase

Clinical Trial Phase for PEMOLINE
Clinical Trial Phase Trials
Phase 2 4
N/A 1
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Clinical Trial Status

Clinical Trial Status for PEMOLINE
Clinical Trial Phase Trials
Completed 2
Unknown status 2
Withdrawn 1
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Clinical Trial Sponsors for PEMOLINE

Sponsor Name

Sponsor Name for PEMOLINE
Sponsor Trials
National Institute on Drug Abuse (NIDA) 2
VA Connecticut Healthcare System 1
Yale University 1
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Sponsor Type

Sponsor Type for PEMOLINE
Sponsor Trials
Other 4
NIH 2
U.S. Fed 1
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