Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 16 - 40 |
| Updated: | 5/12/2017 |
| Start Date: | June 2003 |
| End Date: | December 2011 |
Modafinil and Nicotine in Adolescents: Phase I Trial
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.
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.
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).
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).
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
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