Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tobacco Use Disorder
Intervention: Modafinil (Drug); Nicotine Replacement Therapy (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Catherine Martin, PhD, Study Chair, Affiliation: University of Kentucky
Overall contact:
Catherine A. Martin, MD, Phone: 859-257-9341, Email: cmartin@uky.edu
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.
Clinical Details
Official title: Modafinil and Nicotine in Adolescents: Phase I Trial
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety Study
Primary outcome: Safety of combination drug treatment and physiological response; measured after treatment with each dose combination
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 p. m. 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).
Eligibility
Minimum age: 16 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Smokes 10 or more cigarettes per day
Exclusion Criteria:
- Current use of any medication for a psychiatric disorder
- Positive drug screen test
- Uses smokeless tobacco
Locations and Contacts
Catherine A. Martin, MD, Phone: 859-257-9341, Email: cmartin@uky.edu
University of Kentucky, Lexington, Kentucky 40509, United States; Recruiting
Catherine Martin, MD, Phone: 859-257-9341, Email: cmartin@uky.edu
Catherine A. Martin, MD, Principal Investigator
Additional Information
Starting date: June 2003
Ending date: March 2009
Last updated: September 29, 2008
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