Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258479
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2005-11-22
Brief Title:
Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents
Sponsor:
Catherine Martin MD
Organization:
University of Kentucky
Study Overview
Official Title:
Modafinil and Nicotine in Adolescents Phase I Trial
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nicotine is one of the most widely abused substances in the United States Nicotine replacement therapy NRT is currently an effective treatment for nicotine dependence however even with NRT most people fail at quitting smoking after their first attempt Modafinil is a promising drug that may be useful in treating nicotine dependent individuals The purpose of this study is to evaluate the safety of the combination of modafinil and NRT in treating nicotine dependent adolescent smokers
Detailed Description:
NRT is a critical part of treating nicotine withdrawal symptoms such as cravings sleeplessness poor concentration and anxiety The addition of modafinil a promising pharmacologic agent may enhance the effectiveness of NRT by further reducing inattention and depressed mood The purpose of this study is to examine the safety of using both modafinil and NRT in treating nicotine dependent adolescents In addition this study will examine the effects of modafinil and NRT alone and in combination on alleviating symptoms of inattention and depressed mood
Participants in this 12-day dose escalation study will be tested under eight different dose conditions Modafinil and NRT will first be tested alone participants will be exposed to low doses prior to higher doses of medication Various modafinil-NRT dose combinations will then be tested Modafinil will be administered at 5 pm each day and NRT will be self-administered at the start of each day in which a participant must complete lab tests The following measures will be obtained at study visits occurring before and after the various modafinil-NRT dose combinations nicotine withdrawal symptoms medication side effects activity level cardiovascular response and profile of mood states POMS
Participants in this 12-day dose escalation study will be tested under eight different dose conditions Modafinil and NRT will first be tested alone participants will be exposed to low doses prior to higher doses of medication Various modafinil-NRT dose combinations will then be tested Modafinil will be administered at 5 pm each day and NRT will be self-administered at the start of each day in which a participant must complete lab tests The following measures will be obtained at study visits occurring before and after the various modafinil-NRT dose combinations nicotine withdrawal symptoms medication side effects activity level cardiovascular response and profile of mood states POMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMCDA | US NIH GrantContract | None | httpsreporternihgovquickSearchR03DA015413 |
| R03DA015413 | NIH | None | None |